# QPS Engineering AG > Innovative engineering solutions for pharma, biotech & food technology. > Contact: info@qps-engineering.ch ### Pages #### Account URL: https://qpsag.com/my-account/ #### Apply for a role at QPS Apply for a role at QPS At QPS Engineering AG, we’re always looking for passionate individuals who are ready to shape the future of pharmaceutical and biotech engineering. we look forward to learning more about you. 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Greenling sleeper. Call Center 800 100 975 20 34+ (123) 1800-234-5678 Our Location 800 100 975 20 34+ (123) 1800-234-5678 USA, New York – 1060Str. First Avenue 1 Email neuros@mail.co Social network neuros@mail.co Facebook-f X-twitter Linkedin-in Youtube #### Categories URL: https://qpsag.com/categories/ #### Checkout URL: https://qpsag.com/checkout/ #### Contact get in touchWe are always ready to take your requests QPS Engineering AG Backoffice Phone +41 56 281 91 14 Email info@qpsag.com Our Location Schaffhauserstrasse 304332 Stein, Switzerland Social network X-twitter Linkedin-in Youtube Instagram First Name *Email Address *Phone NumberMessage0 / 180SubmitPlease do not fill in this field. #### csv [CSV Training - Initialisierung] CSV TRAINING Systeminitialisierung: CSV Grundausbildung Willkommen im CSV Training Terminal. Entdecken Sie die Grundlagen der Computer System Validation. Trainingsmodule: ⚡ CSV Fundamentals & Bedeutung 📋 Regulatorische Anforderungen ⚠️ Risiken & Compliance ✅ Best Practices & Implementation 🎯 Mission: Entwicklung validierter, sicherer und GMP-konformer Systeme System bereit DRÜCKEN SIE "WEITER" ZUM STARTEN [CSV Training - Module 02] +---------------------------------------------------------------+ | WARNING: SYSTEM FAILURE DETECTED | |---------------------------------------------------------------| | CRITICAL ERROR: VALIDATION INTEGRITY COMPROMISED | |---------------------------------------------------------------| | ERROR CODE: 0xVAL1234 | | IMPACT: DATA LOSS, SYSTEM DOWNTIME, PATIENT SAFETY RISK | +---------------------------------------------------------------+ SYSTEM PANIC VALIDATION FAILURE DETECTED: Datenintegrität und Systemzuverlässigkeit gefährdet. Folgen: Datenverlust: Kritische Patientendaten sind unbrauchbar. Produktionsausfall: Kosten in Millionenhöhe. Regulatorische Sanktionen: Strafzahlungen und Produktionsverbot. Patientensicherheit: Gefährdung durch fehlerhafte Produkte. Real Life Beispiel: Ein Pharmakonzern musste 500.000 Einheiten eines Medikaments zurückrufen, weil das Produktionssystem nicht korrekt validiert war. Der Schaden belief sich auf über 10 Mio. €. DRÜCKEN SIE "Weiter", UM FORTZUFAHREN [CSV Training - Grundlagen] Computer System Validation 📋 Definition Computer System Validation (CSV) ist ein strukturierter Prozess zur Sicherstellung, dass computergestützte Systeme sicher, zuverlässig und regulatorisch konform arbeiten. Kernaspekte der CSV 🔒 Datenintegrität Sichere und zuverlässige Datenhaltung 👥 Patientensicherheit Schutz von Gesundheit und Leben ⚖️ Compliance FDA 21 CFR Part 11, EU GMP Annex 11 ⚡ Risikominimierung Verhinderung von Produktionsausfällen 💡 Wichtig: CSV bedeutet nicht nur Compliance – es schützt auch Ihr Unternehmen vor Risiken und Kosten! CSV Grundlagen bereit DRÜCKEN SIE "Weiter" FÜR DETAILS [CSV Training - Regulatorische Grundlagen] Regulatorische Anforderungen 📋 GxP Standards GMP: Good Manufacturing Practice GLP: Good Laboratory Practice GCP: Good Clinical Practice GDP: Good Distribution Practice Grundlegende Qualitätsstandards für die Pharmabranche 🏛️ FDA 21 CFR Part 11 Kernforderungen: System Access Control Audit Trail Elektronische Signaturen Datenintegrität Systemsicherheit US-Standard für elektronische Systeme 🌍 EU GMP Annex 11 Hauptaspekte: Risikobasierter Ansatz Validierung Datenspeicherung Systemfreigabe Periodische Evaluation EU-Richtlinie für computergestützte Systeme Konsequenzen bei Nichteinhaltung ⚠️ Warning Letter der FDA 🚫 Produktionsstopp 💰 Strafzahlungen 📉 Imageschaden 💡 Praxisbeispiel Ein Pharmaunternehmen erhielt 2023 einen FDA Warning Letter, weil: Keine ausreichende Zugangskontrolle Fehlender Audit Trail bei kritischen Daten Mangelhafte Dokumentation der Systemvalidierung Kostenpunkt: $3.5 Millionen plus 6 Monate Produktionsausfall Regulatorische Anforderungen identifiziert DRÜCKEN SIE "Weiter" FÜR DETAILS ZUR UMSETZUNG [KRITISCHE SYSTEMRISIKEN] GEFÄHRDUNGSSTUFE: KRITISCH ⚠️ VALIDIERUNGSMÄNGEL FESTGESTELLT ⚠️ RISIKOANALYSE: FEHLENDE VALIDIERUNG 💾 Datenverlust KRITISCH Verlust von Patientendaten Beschädigte Chargenprotokolle Kompromittierte Audit Trails Unrettbare Testresultate 🏭 Produktionsausfälle SCHWERWIEGEND Komplettausfall der Produktion Verzögerte Markteinführungen Fehlerhafte Chargen Lieferengpässe ⚖️ Regulatorische Folgen KRITISCH FDA Warning Letters Produktionsstilllegung Millionenstrafen Marktzulassungsverlust 🏥 Patientensicherheit KRITISCH Fehlerhafte Medikation Kontaminierte Produkte Falsche Dosierungen Gesundheitsgefährdung ⚠️ REALE VORFÄLLE 500.000 Rückruf-Einheiten 10 Mio. CHF Schaden 3 Monate Stillstand Ein Schweizer Pharmakonzern musste aufgrund unvalidierter Produktionssysteme einen Massenrückruf starten. Die fehlerhaften Daten führten zu falschen Qualitätsprüfungen. 2.5 Mio. USD Strafe 100% Produktionsstopp 6 Monate Sperrung Ein US-Hersteller erhielt einen FDA Warning Letter wegen mangelhafter Systemvalidierung. Alle Produktionslinien mussten gestoppt werden. PRÄVENTIONSMASSNAHMEN ERFORDERLICH WEITER ZU GRUNDLAGEN [CSV Training - Validierungsprozess] CSV Grundlagen 📋 Was ist CSV? Computer System Validation (CSV) ist ein systematischer Prozess, der sicherstellt, dass ein computergestütztes System konsistent und zuverlässig funktioniert und alle regulatorischen Anforderungen erfüllt. Der Validierungsprozess 01 ⚙️ Installation Qualification IQ Hardware-Installation Software-Installation Konfiguration Dokumentation 02 🔍 Operational Qualification OQ Funktionsprüfung Standardprozesse Fehlertests Kontrollen 03 ✅ Performance Qualification PQ Realbetrieb Leistungstests Prozessvalidierung Akzeptanz 🎯 Risikobasierter Ansatz 📄 Dokumentierte Nachweise 🔄 Kontinuierliche Prüfung Validierungsprozess bereit WEITER ZUR NÄCHSTEN PHASE [CSV Training - V-Modell] Das V-Modell Das V-Modell verknüpft jede Entwicklungsphase mit einer entsprechenden Validierungsphase. 📋 Benutzeranforderungen URS ✅ Performance Qualification PQ Validiert 📝 Funktionale Spezifikation FS 🔍 Operational Qualification OQ Verifiziert 🔨 Detail Design DS ⚙️ Installation Qualification IQ Installiert 💻 Implementierung Rückverfolgbarkeit Jede Anforderung wird getestet Validierung Systematische Qualifizierung Dokumentation Lückenlose Nachweise WEITER ZUM NÄCHSTEN MODUL [CSV Training - Risikoanalyse] Risikoanalyse in CSV ⚠️ Systematische Identifikation und Bewertung von Systemrisiken für Patientensicherheit und Produktqualität Risikomatrix Auswirkung → Wahrscheinlichkeit ↓ Gering Mittel Hoch Hoch Mittel Hoch Kritisch Mittel Niedrig Mittel Hoch Gering Niedrig Niedrig Mittel Risikoanalyse-Prozess 1 Identifikation Risikoquellen identifizieren Gefährdungen dokumentieren Prozesse analysieren 2 Bewertung Wahrscheinlichkeit bestimmen Auswirkungen bewerten Risikostufe ermitteln 3 Maßnahmen Kontrollen implementieren Präventive Maßnahmen Monitoring einrichten Beispiel: Medikamentendosierung Risiko: Fehlerhafte Dosierung Wahrscheinlichkeit: Mittel Auswirkung: Hoch Maßnahmen: Automatische Plausibilitätsprüfungen 4-Augen-Prinzip bei Eingabe Regelmäßige Systemvalidierung Risikoanalyse verstanden WEITER ZUM NÄCHSTEN MODUL [CSV Training - Requirements Engineering] Anforderungsmanagement 📋 Anforderungen bilden das Fundament der Validierung. Sie definieren präzise, was ein System leisten muss und wie es getestet wird. 👥 URS User Requirements Benutzeranforderungen Geschäftsprozesse Funktionale Erwartungen Rahmenbedingungen Beispiel: "System muss Chargen-Freigabe durch QA ermöglichen" ↓ ⚙️ FS Functional Specification Funktionale Spezifikation Systemprozesse Funktionsabläufe Schnittstellen Beispiel: "Elektronische Signatur mit 2-Faktor-Authentifizierung" ↓ 🔧 DS Design Specification Technische Spezifikation Technische Details Systemarchitektur Implementierung Beispiel: "OAuth2 mit JWT-Token und SSL-Verschlüsselung" ✨ Best Practices 📌 Eindeutig & präzise 🎯 Testbar 🔄 Rückverfolgbar 📊 Messbar Beispiel einer guten Anforderung: [REQ-001] Das System MUSS Passwörter mit folgenden Kriterien erzwingen: Mindestlänge: 12 Zeichen Mind. 1 Großbuchstabe Mind. 1 Sonderzeichen Mind. 1 Zahl 🎯 Testbar 📋 Eindeutig 📊 Messbar Requirements Engineering verstanden WEITER ZUM NÄCHSTEN MODUL [CSV Training - Design Review] Design Review Prozess 🔍 Ein systematischer Prozess zur Überprüfung des Systemdesigns, der Qualität sichert und Risiken minimiert. 1 📋 Vorbereitung Design-Dokumente sammeln Review-Team zusammenstellen Checklisten vorbereiten 2 ⚡ Analyse Anforderungsabdeckung prüfen Technische Machbarkeit bewerten Risiken identifizieren 3 💭 Feedback Ergebnisse dokumentieren Verbesserungen vorschlagen Maßnahmen definieren 4 ✅ Umsetzung Änderungen implementieren Nachverfolgung sicherstellen Ergebnisse verifizieren 💰 Kostenersparnis Frühe Fehlererkennung reduziert Nachbesserungskosten 🎯 Qualitätssicherung Systematische Prüfung aller Designaspekte 🤝 Zusammenarbeit Verbesserte Kommunikation zwischen Teams ⚡ Effizienz Optimierte Entwicklungsprozesse ✓ Review Checkliste ✓ Erfüllung aller Anforderungen ✓ Technische Machbarkeit ✓ Regulatorische Compliance ✓ Risikobetrachtung Review-Prozess verstanden WEITER ZUM NÄCHSTEN MODUL [CSV Training - Testmethoden] 🎯 Performance Qualification (PQ) Praxistest Reale Bedingungen Produktionsprozesse Langzeitverhalten Beispieltest: "30-Tage Produktionssimulation mit echten Daten" ⚙️ Operational Qualification (OQ) Funktionstest Standardfunktionen Fehlerfälle Grenzwerte Beispieltest: "Eingabevalidierung mit Grenzwerten und Sonderfällen" 📦 Installation Qualification (IQ) Installationstest Systemkomponenten Konfiguration Basisfunktionen Beispieltest: "Verifizierung aller installierten Module und Konfigurationen" ✨ Testprinzipien 🔄 Reproduzierbar Gleiche Bedingungen, gleiche Ergebnisse 📊 Messbar Klare Erfolgskriterien 📝 Dokumentiert Vollständige Nachverfolgbarkeit 🎯 Zielgerichtet Fokus auf kritische Funktionen Testdokumentation 📋 Testprotokoll ⚠️ Abweichungen ✅ Ergebnisse 📊 Auswertung Testmethoden verstanden WEITER ZUM NÄCHSTEN MODUL [CSV Training - Dokumentation] 📚 Das Dokumentations-Framework in CSV 1 Planungsphase 📋 Validierungsplan VP Validierungsstrategie Zeitplan Verantwortlichkeiten 📄 Requirements URS/FS Systemanforderungen Funktionen Spezifikationen 2 Durchführungsphase 📝 Testprotokolle IQ/OQ/PQ Testschritte Ergebnisse Abweichungen ⚠️ Abweichungsberichte DR Problembeschreibung Auswirkungen Maßnahmen 3 Abschlussphase ✅ Validierungsbericht VR Zusammenfassung Bewertung Freigabe 📊 Traceability Matrix TM Anforderungen Tests Ergebnisse 🔍 Nachvollziehbarkeit Lückenlose Dokumentation aller Schritte ✍️ ALCOA+ Attributable, Legible, Contemporaneous, Original, Accurate 🔐 Integrität Sichere Aufbewahrung und Versionierung ⚖️ Compliance Erfüllung regulatorischer Anforderungen Dokumentationsanforderungen verstanden WEITER ZUM NÄCHSTEN MODUL [CSV Training - Change Control] 🔄 Kontrolliertes Änderungsmanagement 01 Change Request 📝 Änderungsantrag Begründung Umfang 02 Impact Analysis 🔍 Risikoanalyse Betroffene Systeme GMP-Impact 03 Implementierung ⚙️ Umsetzung Test Dokumentation 04 Review & Freigabe ✅ QA Review Genehmigung Abschluss ⚡ Change Control Kritische Kontrollpunkte ⚠️ Risikobewertung 📊 Validierungsbedarf 📝 Dokumentation 👥 Freigabe ⚠️ Risiko unkontrollierter Änderungen Ungeprüfte Änderungen können zu: Systemausfällen Datenverlusten Compliance-Verstößen Produktionsunterbrechungen führen. Change Control verstanden WEITER ZUM NÄCHSTEN MODUL [CSV Training - Periodic Review] 🔄 Systematische Überprüfung validierter Systeme 📊 Datenanalyse Performance-Metriken Fehlerprotokolle Nutzungsstatistiken ⚡ System-Check Konfigurationen Updates Schnittstellen 📋 Compliance Regulatorische Änderungen SOP-Updates Audit-Findings ✅ Bewertung Risikoanalyse Maßnahmenplan Freigabe 2024 Periodic Review Prüfungsschwerpunkte 🎯 Performance Systemstabilität Antwortzeiten Ressourcennutzung ⚖️ Compliance GMP-Konformität Datenintegrität Audit Trail 🔒 Sicherheit Zugriffsrechte Backup/Recovery Verschlüsselung 📚 Dokumentation SOP-Aktualität Trainingsstand Change History 📅 Review-Zyklus Q1 Datensammlung Q2 Analyse Q3 Maßnahmen Q4 Abschluss Review-Prozess verstanden WEITER ZUM NÄCHSTEN MODUL [CSV Training - Datenintegrität] 🛡️ Datenintegrität: Das Fundament von GMP ALCOA Prinzipien 👤 A Attributable Nachvollziehbare Zuordnung Kontrollen: Unique User IDs Elektronische Signaturen Audit Trail 📖 L Legible Lesbar und dauerhaft Kontrollen: Standardformate Klare Darstellung Sichere Speicherung ⏱️ C Contemporaneous Zeitnahe Erfassung Kontrollen: Zeitstempel Direkte Erfassung Automatisierung 📄 O Original Ursprüngliche Form Kontrollen: Versionierung Raw Data Speicherung Änderungskontrolle ✅ A Accurate Korrekt und präzise Kontrollen: Validierung Kalibrierung Qualitätschecks 🔒 Technische Kontrollen 📝 Audit Trail Lückenlose Aufzeichnung aller Änderungen 🔐 Zugriffskontrollen Rollenbasierte Berechtigungen 💾 Backup Regelmäßige Datensicherung 🔍 Validierung Automatische Plausibilitätsprüfungen Best Practices Regelmäßige Systemprüfungen durchführen Mitarbeiter kontinuierlich schulen SOPs aktuell halten Risikobewertungen durchführen Datenintegrität verstanden WEITER ZUM NÄCHSTEN MODUL [CSV Training - Kritische Fehler] ⚠️ Kritische Fehler im CSV-Prozess 📋 Anforderungsfehler Unvollständige Spezifikationen Unklare Formulierungen Fehlende Akzeptanzkriterien Prävention: ✓ Review-Prozess ✓ Stakeholder-Abstimmung ✓ Template-Nutzung 🧪 Testfehler Unzureichende Testabdeckung Fehlende Edge Cases Mangelhafte Testdaten Prävention: ✓ Testmatrix ✓ Risikobasiertes Testen ✓ Automatisierung 📚 Dokumentationsfehler Fehlende Nachweise Ungenaue Protokollierung Veraltete Dokumente Prävention: ✓ Dokumenten-Management ✓ Versionskontrolle ✓ Review-Zyklen 🔄 Prozessfehler Fehlende Rückverfolgbarkeit Mangelnde Kontrollen Unklare Verantwortlichkeiten Prävention: ✓ Klare SOPs ✓ Rollenmodell ✓ Regelmäßige Audits 📊 Fehler-Impact Matrix Kritisch Produktionsausfall Produktrückruf Behördliche Maßnahmen Hoch Qualitätsprobleme Verzögerungen Zusatzkosten Mittel Prozessineffizienzen Nacharbeiten Dokumentationsaufwand Best Practices zur Fehlervermeidung 👥 4-Augen-Prinzip 📋 Checklisten 🎓 Training 🔄 Reviews Fehlerprävention verstanden WEITER ZUM NÄCHSTEN MODUL [CSV Training - Validierungsplan] 📋 Der Masterplan der Validierung 📑 Aufbau des Validierungsplans 1 Projektbasis Projektziele Geltungsbereich GxP-Relevanz Regulatorische Basis 2 Organisation Rollen & Verantwortlichkeiten Zeitplan Ressourcen Schulungsbedarf 3 Risikobetrachtung Kritikalitätsbewertung Risikoanalyse Kontrollstrategie Maßnahmenplan 4 Validierungsstrategie Validierungsansatz Testmethodik Akzeptanzkriterien Dokumentationsanforderungen Kritische Erfolgsfaktoren 🎯 Klarheit Eindeutige Definitionen und Ziele ⚖️ Vollständigkeit Alle relevanten Aspekte abgedeckt 📊 Messbarkeit Definierte Erfolgskriterien 🔄 Flexibilität Anpassungsfähig bei Änderungen Planungsphase im Validierungsprozess Validierungsplan Risk Assessment Spezifikationen Durchführung Validierungsplan verstanden WEITER ZUM NÄCHSTEN MODUL [CSV Training - Validierungsabschluss] 🎯 Finale Phase: Systemfreigabe Validierung erfolgreich zum Abschluss bringen 📋 Executive Summary Projektübersicht Validierungsziele Kritische Aspekte Gesamtbewertung ✅ Testergebnisse IQ Abgeschlossen OQ Abgeschlossen PQ Abgeschlossen ⚠️ Abweichungsmanagement Typ Anzahl Status Kritisch 0 ✓ Major 2 Gelöst Minor 3 Gelöst 🚀 Freigabeempfehlung ✓ System freigegeben Validation Lead Genehmigt Quality Assurance Genehmigt System Owner Genehmigt Abschluss-Checkliste ✓ Alle Tests abgeschlossen ✓ Dokumentation vollständig ✓ Abweichungen bearbeitet ✓ Unterschriften eingeholt Validierung erfolgreich abgeschlossen WEITER ZUM NÄCHSTEN MODUL [CSV Training - Change Control] Change Control Workflow 1 Änderungsantrag Beschreibung der Änderung Begründung Betroffene Systeme ⬇️ 2 Risikobewertung Niedrig: Kleine UI-Anpassungen Mittel: Funktionsänderungen Hoch: Kritische Systeme ⬇️ 3 Test & Validierung 🔍 Unit Tests ⚙️ Integration ✅ Validierung ⬇️ 4 Freigabe & Dokumentation 📝 Änderungsdokumentation 👥 QA Review ✍️ Finale Freigabe ⚠️ Kritische Hinweise Keine Änderungen ohne Dokumentation Immer Backup vor Änderungen Test in separater Umgebung Rollback-Plan vorbereiten Change Control verstanden WEITER ZUM NÄCHSTEN MODUL [CSV Training - Validierungs-Lebenszyklus] Der Validierungs-Lebenszyklus ╔══════════════════════════════════════════════════╗ ║ VALIDIERUNG: VON A BIS Z ║ ║ Ein vollständiger End-to-End Überblick ║ ╚══════════════════════════════════════════════════╝ 📋 1. Planungsphase Erforderliche Dokumente: Validation Plan (VP) User Requirements Specification (URS) Functional Requirements Specification (FRS) Configuration Specification (CS) Traceability Matrix Risk Assessment 🔍 2. Spezifikationsphase Erforderliche Dokumente: Design Specification (DS) Module Specification Hardware Specification Software Specification Interface Specification ⚡ 3. Installationsphase Erforderliche Dokumente: Installation Qualification Protocol (IQ) Installation Checklist Network Documentation Hardware/Software Installation Logs Configuration Documentation 🔧 4. Operationsphase Erforderliche Dokumente: Operational Qualification Protocol (OQ) Test Scripts Test Cases Standard Operating Procedures (SOPs) User Manuals 🎯 5. Leistungsphase Erforderliche Dokumente: Performance Qualification Protocol (PQ) Performance Test Results User Acceptance Tests Process Validation Data 📊 6. Berichtsphase Erforderliche Dokumente: Validation Summary Report Deviation Reports Change Control Records Training Records 🔄 7. Wartungsphase Laufende Aktivitäten: Periodic Review Change Management Incident Management Backup & Recovery Procedures System Monitoring 🎯 Wichtige GAMP 5 Prinzipien: Risikobasierter Ansatz Lebenszyklusmodell Skalierbare Aktivitäten Qualität durch Design Verifizierung durch Testing 🔐 ALCOA+ Prinzipien: Attributable Legible Contemporaneous Original Accurate Complete Consistent Enduring Available Validierung ist ein kontinuierlicher Prozess, keine einmalige Aktivität! [CSV Training - Regulatorische Behörden] Regulatorische Überwachung 🌐 Globale Behörden 🏛️ FDA USA Food and Drug Administration 21 CFR Part 11 Arzneimittelzulassung GMP Inspektionen Medizinprodukte 🇪🇺 EMA EU European Medicines Agency EU GMP Annex 11 Zentrale Zulassung Pharmakovigilanz Harmonisierung 🌍 WHO Global World Health Organization Globale Standards GMP Guidelines Qualitätssicherung Internationale Koordination 🏴 Nationale Behörden 🇩🇪 BfArM Bundesinstitut für Arzneimittel Arzneimittel & Medizinprodukte 🇨🇭 Swissmedic Schweizerisches Heilmittelinstitut Heilmittelkontrolle 🇬🇧 MHRA Medicines & Healthcare Products UK Regulierung ⚠️ Wichtig für Compliance Lokale und globale Anforderungen beachten Regelmäßige Updates zu Regularien verfolgen Proaktive Kommunikation mit Behörden Dokumentation aller behördlichen Interaktionen Behördliche Strukturen verstanden WEITER ZUM NÄCHSTEN MODUL [CSV Training - Regulatorische Richtlinien] CSV Regulatorischer Rahmen 🏛️ 21 CFR Part 11 FDA 🔐 Systemzugang & Berechtigungen 📝 Elektronische Signaturen 📊 Audit Trail 💾 Datensicherung 🇪🇺 EU GMP Annex 11 EMA ⚖️ Risikobasierter Ansatz 🔄 Validierung & Qualifizierung 📋 Dokumentation 🔍 Datenintegrität 📘 GAMP 5 ISPE 1 Infrastruktur 3 Non-Configured 4 Configured 5 Custom 🌐 ISO Standards 9001 QMS 27001 Security 🎯 ALCOA Prinzipien A Attributable L Legible C Contemporaneous O Original A Accurate 💡 Compliance Fokus Regelmäßige Überprüfung der Richtlinien-Updates Integration neuer Anforderungen in bestehende Systeme Dokumentierte Gap-Analyse bei Änderungen Schulung der Mitarbeiter zu neuen Anforderungen Richtlinien verstanden WEITER ZUM NÄCHSTEN MODUL [CSV Training - Validierungs-Workflow] ⚡ Validierungs-Workflow 01 📋 Planungsphase Kernaktivitäten: Validierungsplan (VP) erstellen Ressourcen planen Zeitplan definieren Team zusammenstellen 📄 Dokumente: Validation Plan Risk Assessment Project Timeline ▼ 02 📝 Spezifikationsphase Kernaktivitäten: Anforderungen definieren Funktionen spezifizieren Design dokumentieren Reviews durchführen 📄 Dokumente: URS FRS Design Specification ▼ 03 🔧 Implementierung Kernaktivitäten: System installieren Konfiguration durchführen Initiale Tests Dokumentation erstellen 📄 Dokumente: Installation Protocol Configuration Guide Test Scripts ▼ 04 🔍 Qualifizierung IQ Installation Qualification Hardware Check Software Check Network Setup OQ Operational Qualification Funktionstest Prozesstest Kontrollen PQ Performance Qualification Leistungstest Lasttest Benutzertest ▼ 05 ✅ Abschluss & Freigabe Kernaktivitäten: Ergebnisse reviewen Abweichungen bewerten System freigeben Training durchführen 📄 Dokumente: Validation Report Training Records Release Documentation System Status: VALIDIERUNG IN BEARBEITUNG [CSV Training - CSA vs. CSV] Evolution der Validierung 🏛️ CSV Computer System Validation VS 🚀 CSA Computer Software Assurance 🎯 Ansatz Vollständige Dokumentation Umfassende Tests Risikobasierter Fokus Kritische Funktionen ⚡ Effizienz Zeit-intensiv Optimiert 🔧 Methodik Skriptbasierte Tests Manuelle Durchführung Standardisierte Protokolle Automatisierte Tests Agile Methoden Kontinuierliche Validierung 📊 Dokumentation 📚 Umfangreich 📑 Fokussiert 🤝 Gemeinsame Grundlagen ✓ ALCOA-Prinzipien ✓ GxP-Compliance ✓ Qualitätssicherung 💡 Evolution statt Revolution CSA entwickelt die bewährten CSV-Prinzipien weiter und optimiert sie für moderne Anforderungen. Der Fokus liegt auf effizienter Qualitätssicherung ohne Kompromisse bei der Compliance. Unterschiede verstanden WEITER ZUM NÄCHSTEN MODUL [CSV Training - System Recovery] 🔒 Systemzugang erforderlich Geben Sie das Zugangspasswort ein, um fortzufahren: ZUGANG GEWÄHREN Verbleibende Zeit: 30:00 System Recovery: Beheben Sie den Systemausfall! 🚨 KRITISCHER SYSTEMAUSFALL ERKANNT! 🚨 Um das System wieder online zu bringen, müssen Sie die folgenden Sicherheitsfragen beantworten. Erforderliche Erfolgsquote: 70% System-Status: KRITISCH NEUSTART SYSTEM-DIAGNOSE ← Zurück 1/25 Weiter → Erforderliche Punktzahl: 70% #### Disclaimer Website Disclaimer for QPS Engineering AG General Information Welcome to our website, www.qpsag.com. The information provided on this site is for general informational purposes only. All information on the site is provided in good faith, however, we make no representation or warranty of any kind, express or implied, regarding the accuracy, adequacy, validity, reliability, availability, or completeness of any information on the site. External Links Disclaimer Our website may contain (or you may be sent through the site to) links to other websites or content belonging to or originating from third parties or links to websites and features. Such external links are not investigated, monitored, or checked for accuracy, adequacy, validity, reliability, availability, or completeness by us. Errors and Omissions Disclaimer The information given by QPS Engineering AG is for general guidance on matters of interest only. Even if QPS Engineering AG takes every precaution to ensure that the content of this website is both current and accurate, errors can occur. Plus, given the changing nature of laws, rules, and regulations, there may be delays, omissions, or inaccuracies in the information contained on this site. Fair Use Disclaimer This website reviews products, services, and processes. For this purpose, we use trademarks and products belonging to third parties. These are used only to identify the products and services and to provide thorough reviews. Contact Us Should you have any feedback, comments, requests for technical support, or other inquiries, please contact us by email: info@qpsag.com. #### Home Unlock smarter, faster, and more efficient production with innovation and digital transformation Discover moreengineering what life-science needs nextUnlock smarter, faster, and more efficient production with innovation and digital transformation Discover moreengineering what life-science needs nextUnlock smarter, faster, and more efficient production with innovation and digital transformation Discover moreengineering what life-science needs nextUnlock smarter, faster, and more efficient production with innovation and digital transformation Discover moreengineering what life-science needs next Watch video Watch video Four business units. One purpose. Compliance that performs. servicesBusiness Units Engineering Consulting Project ManagementVisual InspectionQualification / ValidationGMP ComplianceFill & FinishPackaging Visual Inspection Technology Defect Test Sets & SamplesLaser-Drilled Reference ContainersVisual Inspection TrainingDefect CatalogueQualification SupportContainer Closure Integrity Testing (CCIT) Measurement Technology Material IdentificationSurface Roughness MeasurementLUX (Light Intensity) MeasurementTemperature MeasurementNoise Level Measurement Digital Transformation Robotic Visual Inspection AI-Based Business Solutions Robotic Systems Selection & Integration Your Partner in GxP Compliance End-to-End Engineering, Project Management, and Compliance for Pharma and Biotech and Food Industry Linkedin Youtube  Qengineering  /   Qlabs   /  Qmeasure   /   QxTec   /  Qengineering  /   Qlabs   /  Qmeasure   /   QxTec   /   We engineer what lifescience needs next  /  We engineer what lifescience needs next  /  aboutA Message from Our CEO, Sergej Ruppel QPS GxP I founded QPS back in 2017 with a clear goal: to deliver solutions that help my customers become more compliant and effective. Since then, at QPS Engineering AG, I have stayed true to that mission by developing and implementing innovative, precise solutions tailored to each client’s needs—ensuring every project achieves the highest standards of quality and efficiency. With strong expertise in the life sciences, my team delivers solutions to complex challenges, supporting clients from concept through to completion. Together, we focus on building lasting partnerships and continuously optimizing processes to create measurable, long-term value. I am also deeply fascinated by the potential of AI and robotics, and by how these technologies can transform life science production. By integrating advanced automation and intelligent systems into our solutions, we aim to unlock new levels of efficiency, quality, and flexibility for our customers. Sergej Ruppel Meet the Management this is usOur Key Strengths & Advantages Experienced Team Our team of experts brings decades of combined experience in Pharma, Biotech, and Food Tech, ensuring precise solutions tailored to your specific industry needs. Customised Solutions We design and deliver bespoke solutions, fully aligned with your business objectives and regulatory requirements, ensuring optimal performance and compliance. Innovative Technologies We leverage state-of-the-art technology and methodologies, including process automation and GxP compliance systems, to ensure efficient and forward-thinking project execution. Proven Success Our portfolio includes numerous successful projects, from pharmaceutical manufacturing facilities to biotech labs, consistently delivering results that exceed client expectations. Working with QPS Engineering AG has significantly enhanced our operations. Their tailored solutions have allowed us to streamline processes and meet regulatory requirements with ease. We couldn’t be more pleased with the results.John AndersonCEOQPS Engineering AG has taken our projects to the next level. Their expertise has helped us overcome complex technical challenges while maintaining the highest standards of quality and safety. The results speak for themselves.Frank BarrowCEO testimonialsHear what our customers say about our GxP solutions Happy clients 0 + blogUnlocking the Future: Innovations and trends in Engineering More articles February 19, 2024info@qps-engineering.chWelcome to the New QPS Engineering AG Website – New Look, New Features!We are thrilled to announce the launch of our newly redesigned websiteNews & Updates June 22, 2026info@qps-engineering.chArtificial Intelligence in Pharmaceutical Inspection: Improving Quality Through Better AlgorithmsUncategorized More articles faqEverything you need to know about What services does QPS Engineering AG offer? QPS Engineering AG offers services through four specialized divisions:1. QEngineeringEngineering consulting, project management, and custom solutions for industrial challenges.2. QLabsDevelopment of test kits and visual inspection tools for pharma and biotech.3. QMeasureCalibration, sensor integration, and metrology for regulated environments.4. QxTecAutomation and robotics platforms, including machine vision systems.GMP ServicesQPS also provides GMP consulting, system qualification, and validation support. Where is QPS Engineering AG located? Answer: Our headquarters is located at Schaffhauserstrasse 30, 4332 Stein, Switzerland. From this central location, we serve clients both locally and globally. How can I contact QPS Engineering AG? Answer: You can contact us by phone at +41 56 281 91 14 or by email at info@qps-engineering.ch. Our team is ready to assist you with any inquiries or service requests. What makes QPS Engineering AG different from other engineering firms? Answer: QPS Engineering AG stands out due to our commitment to innovation, quality, and sustainability. We employ cutting-edge technologies and methodologies to ensure that our solutions are not only effective but also environmentally sustainable. Our team’s extensive experience and proactive approach to project management ensure that we deliver superior results consistently. Can QPS Engineering AG handle international projects? Answer: Yes, we have the capability and experience to manage international projects. Our team is equipped to provide services globally, adhering to international standards and regulations to ensure project success. What industries does QPS Engineering AG serve? Answer: We primarily serve the pharmaceutical, biotechnology, and food technology industries. Our solutions are designed to meet the unique challenges and regulatory requirements of these sectors. How does QPS Engineering AG ensure compliance with industry regulations? Answer: We adhere strictly to industry-specific regulations, including GMP guidelines for pharmaceuticals and biotech industries. Our team stays up-to-date with the latest regulations and incorporates compliance into every aspect of our project planning and execution. Does QPS Engineering AG offer customized solutions? Answer: Absolutely. We believe that every client and project has unique needs, and we specialize in creating customized solutions that meet these specific requirements. Our approach involves a detailed analysis of your needs followed by the development of tailored solutions. What is the process for starting a project with QPS Engineering AG? Answer: The first step is to contact us with your project needs. From there, we will arrange a consultation to discuss your requirements in detail. After the initial consultation, we will provide a proposal that outlines the project scope, timeline, and budget. How does QPS Engineering AG ensure project success? Answer: We ensure project success through rigorous planning, constant communication with our clients, and strict adherence to project timelines and budgets. Our quality assurance process involves regular reviews and adjustments as needed to meet project goals. Explore more contact usWe are always ready to take your requests QPS Engineering AG Backoffice Phone +41 56 281 91 14 Our Location +41 56 281 91 14 Schaffhauserstrasse 30 4332 Stein, Switzerland Email info@qpsag.com Social network info@qpsag.com Linkedin-in Youtube Instagram #### ILMAC 2025 Downloads Zugang zu unseren Client Downloads Enter your email for exclusive client downloads E-Mail-Adresse * Firmenname * Interessen (Optional) Ich stimme zu, Mitteilungen von QPSAG zu erhalten und verstehe die Datenschutzerklärung Jetzt Zugang erhalten Ihr Account wird erstellt... Zugang beschränkt Bitte registrieren Sie sich oben, um Zugang zu unseren Client Downloads zu erhalten. #### Intro Meet Powerfull of Artificial Intelligence WordPress Theme Scroll down See demo Awesome collection of different blocks 0 + With a great range of blocks, widgets, and pages, you’ll have everything youq need to create a truly exceptional website, that stands out from the crowd Solutions Plugins Install only three free plugins for full working: Elementor, Woocommerce & WPForms Multilingual RTL Multilingual, RTL & translation ready Pre-built pages 0 + Unleashing the Potential of Artificial Intelligence for Intelligent Solutions 0 + WOW! Meet incredable & creative demo pages Unique design Free Life Time Update Fast & Friendly Support 01. HomeArtificial Intelligence 04. HomeImage Generator 03. HomeAI Agency  07. HomeAI Solutions 09. HomeAI Startup 10. HomeVision        New 14. HomeScience Lab New 15. HomeCreative Bureau Coming soon. We’re working on it! 02. 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Well documented We have created useful documentation to help you change your website quickly and easily. All graphic included After purchasing and installing our theme you also get all demo data: fonts, pre-built pages and images for your use. Multilangual We have prepared all the functionality for a quick language change. You only need to install special plugins. User stories: hear what others love about our WordPress themes! manojchouh Nice theme with excellent support from the developers. All of my doubts and requests were fixed within a day. elkab 3 Amazing customer support. I had one modifications and the customer support was super helpful and quick to answer them both. tolunayc code quality very high and they have very detailed documentaion also they have very corporate for customer ticket hikevin2000  the customer suport is excellent！Thank you Sergey for your quick response and everything you did for me! metintahayilma A perfect theme in every respect. 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Thanks for sharing your work. manojchouh Nice theme with excellent support from the developers. All of my doubts and requests were fixed within a day. emil_b Great theme, and great customer support!The author always provided a solution even though it was not theme related.I’ll surely buy new WordPress themes from Artureanec. startelectric2022 I purchased the theme because I really liked the design. After I started working with it I realized that I needed to translate some elements into Romanian. Embrace the future with our Neuros Artificial Intelligence WordPress theme! Buy Neuros now #### Legal Notice Legal Notice (Impressum) Company Name:QPS Engineering AG Address:Schaffhauserstrasse 30,4332 Stein, Switzerland Represented by:Sergej Ruppel Contact:Phone: +41 56 281 91 14Email: info@qps-engineering.ch Register Court:Aargau Registration Number:CH-400.3.450.705-2 VAT ID:CHE-130.220.943 Economic ID:CHE-130.220.943 #### Login Customizer This page is used for Login Customizer plugin. It will not be visible to your readers. Do not delete it. #### Management QPS Management Team QPS Sergej RuppelLead Engineer & Managing Director (CEO) QPS Sammy DrexlerTechnical Project Manager & Deputy Managing Director QPS Anika RuppelCEO Assistant & Laboratory & Marketing QPS Babak AghahassaniTechnical Project Manager & Senior Project Engineer QPS Jana GudsowatiCEO Assistant & Back Office QPS Roman PaharukovDirector of Visual Inspection #### Meet QPS Welcome to QPS Engineering AG - Your Partners in GxP Excellence aboutWho We Are QPS Engineering AG is a pioneer in providing specialized engineering services that ensure precision, compliance, and sustainability. Our dedicated team of experts brings decades of combined experience to every project, driving innovation and excellence.Our MissionWe strive to lead the way in engineering solutions by integrating the latest technologies, adhering to rigorous standards, and fostering a culture of continuous improvement. Our mission is to deliver superior results that not only meet but exceed our clients’ expectations. QPS/GXP Innovative Solutions Across Multiple Sectors: Pharmaceuticals: From process optimization to compliance and safety enhancements.Biotechnology: We design facilities and processes that are flexible and scalable, meeting the needs of tomorrow’s biotech advancements.Food Technology: Implementing robust systems that increase efficiency while ensuring product quality. Watch video Watch video Client-Centric Approach: We tailor our services to meet the specific needs of each client, ensuring highest quality in engineering practice clients served 0 + Powered by teamThe QPS Leadership Team welcomes you Awesome team members 0 + Meet The Team QPS Babak AghahassaniTechnical Project Manager & Senior Project Engineer QPS Sergej RuppelLead Engineer & Managing Director (CEO) QPS Jana GudsowatiCEO Assistant & Back Office QPS Anika RuppelCEO Assistant & Laboratory & Marketing QPS Sammy DrexlerTechnical Project Manager & Deputy Managing Director contact usWe are always ready to take your requests QPS Engineering AG Backoffice Phone +41 56 281 91 14 Our Location +41 56 281 91 14 Schaffhauserstrasse 30 4332 Stein, Switzerland Email info@qpsag.com Social network info@qpsag.com Linkedin-in Youtube Instagram #### Mermaid Mermaid Live Editor #### messe URL: https://qpsag.com/messe/ #### News June 22, 2026info@qps-engineering.chArtificial Intelligence in Pharmaceutical Inspection: Improving Quality Through Better AlgorithmsInspection of parenteral products is essential in pharmaceutical manufacturing. Every container leaving a facility must meet strict quality standards to ensure patient safety and maintain efficient production. DiscussiUncategorized March 20, 2025info@qps-engineering.chWelcome to the New QPS Engineering AG Website!🚀 We’re Live! After months of development, we are thrilled to officially launch the brand-new website for QPS Engineering AG! Our goal was to create an intuitive and informative platform where clients, partners, aNews & UpdatesTechnology & Innovation October 21, 2024info@qps-engineering.chQPS Engineering AG: Engineering Excellence Meets Innovative SolutionsAt QPS Engineering AG, we don’t just solve problems—we engineer solutions that drive efficiency, compliance, and growth in the Pharma, Biotech, and Food Tech industries. As a team of dedicated engineers with a passNews & Updates February 19, 2024info@qps-engineering.chWelcome to the New QPS Engineering AG Website – New Look, New Features!We are thrilled to announce the launch of our newly redesigned website! At QPS Engineering AG, we have worked hard to create a modern, user-friendly platform that reflects the innovative spirit of our company. With a fNews & Updates #### Privacy Policy Privacy Policy for QPS Engineering AG Welcome to the QPS Engineering AG website (www.qpsag.com). This Privacy Policy outlines our practices concerning the collection, use, and protection of personal information. 1. Information Collection When you visit our website, interact with our services, or contact us via forms, we may collect information that personally identifies you. This includes: Personal Details: Such as name, email address, and phone number when you fill out forms or register for services. Usage Data: Information on how you use the website, including pages accessed and links clicked. Cookies: For details on the types of cookies we use and how they operate, please refer to our Cookie Policy. 2. Use of Information We use the information we collect to: Service Provision: Delivering services you have requested. Communication: Responding to inquiries and sending important updates. Improvement: Enhancing our website and tailoring user experience based on feedback. 3. Information Sharing We do not share your personal data with third parties except: Service Providers: Contractors and service providers we use to support our business, bound by contractual obligations to keep personal information confidential and use it only for the purposes for which we disclose it to them. Compliance and Safety: To comply with the law or to protect the rights, property, or safety of our business, our clients, or others. 4. Data Security We implement measures to protect your personal data against unauthorized access, alteration, disclosure, or destruction. We employ industry-standard practices and security measures, including SSL encryption, to ensure data security. 5. Your Rights You have the right to: Access: Request a copy of your personal data we hold. Rectify: Ask us to correct inaccuracies in your data. Erase: Request the deletion of your data, subject to certain exceptions. Restrict: Limit the way we use your personal data. Object: Challenge certain uses of your personal data. 6. Changes to Privacy Policy We may update this policy from time to time by posting a new version on our website. We will provide notice of significant changes and encourage you to review this policy periodically for the latest information on our privacy practices. 7. Contact Information For any questions or concerns regarding this policy or your personal data, please contact us at: QPS Engineering AGSchaffhauserstrasse 30, 4332 Stein, SwitzerlandPhone: +41 56 281 91 14Email: info@qpsag.com #### Product list URL: https://qpsag.com/shop/ #### Projects Visual Inspection Testset Manufacturing Sterilisation of Systems Qualification LYO for Big Batch Sizes Qualification Fill and Finish Computerized System Validation Support Qualification of AVI Syringes and Vials Product Transfer of different Filling Line contact usWe are always ready to take your requests QPS Engineering AG Backoffice Phone +41 56 281 91 14 Our Location +41 56 281 91 14 Schaffhauserstrasse 30 4332 Stein, Switzerland Email info@qpsag.com Social network info@qpsag.com X-twitter Linkedin-in Youtube Instagram #### Request a Quote [yith_ywraq_request_quote] #### Services servicesWe deliver engineering excellence, ensuring safe and efficient systems with full regulatory compliance. Engineering Consulting We provide comprehensive engineering consulting services, offering expertise in project management, process optimization, and GMP compliance. Our tailored solutions ensure your projects are completed efficiently, on time, and within budget. Visual Inspection Technology Our cutting-edge visual inspection systems enhance quality control through precise defect detection. We specialize in customized solutions for MVI, SAVI, and AVI, ensuring your production processes meet the highest standards. Measurement Technology Our precision measurement services, including illuminance, noise level, and temperature mapping, support quality assurance in critical environments. We offer advanced, reliable tools to guarantee compliance with industry standards. Digital Transformation With the power of AI and robotics we revolutionize your business. Our digital services integrate advanced artificial intelligence solutions and cutting-edge robotic systems to optimize processes, enhance efficiency, and drive innovation.  servicesempowering business transformation with tailored engineering and consulting solutions Our Services At QPS Engineering AG, we deliver tailored engineering and consulting solutions for the Pharma, Biotech, and Food Tech industries. Our approach combines technical precision with an unwavering commitment to compliance, ensuring that every project meets the highest standards of GMP and ISO certifications. QxTecQxTec is dedicated to digital transformation by integrating cutting-edge technologies like artificial intelligence and robotics. QEngineeringQEngineering specializes in GMP-compliant engineering and seamless integration of AI into existing systems. QMeasureQMeasure delivers high-precision measurement services with smart automation for quality-critical environments. QLabsQLabs develops AI-powered visual inspection systems to improve defect detection and operator qualification. Specialized Devisions: Q Engineering: Specialising in custom engineering solutions, we design and implement robust, GMP-compliant systems for the Pharma, Biotech, and Food Tech sectors. From process optimisation to system validation, we provide comprehensive support to ensure the efficiency and compliance of your operational processes.Q Labs: Our dedicated division for visual inspection systems, providing customised test sets (DiS) for MVI, SAVI, and AVI. These systems support critical processes, ensuring operator qualification and improving defect detection across your production line.Q Measure: Delivering precision measurement services such as illuminance, noise level, roughness, non-destructive testing, and temperature mapping. These services are essential for enhancing quality assurance and ensuring consistent product performance.Q xTec: Our cutting-edge division for digital transformation services, QxTec integrates advanced technologies like artificial intelligence (AI) and robotics to revolutionize your operations. We offer tailored solutions in AI-driven process optimization, robotic automation, and cybersecurity, ensuring your business achieves enhanced efficiency, scalability, and innovation. From intelligent data analytics to autonomous systems integration, QxTec empowers your organization to stay competitive in the rapidly evolving digital landscape. servicesOur engineering services help companies achieve the highest standards with compliant solutions. Explore more 01/QxTec/ 01/QxTec/  02/QEngineering/ 02/QEngineering/  03/QMeasure/ 03/QMeasure/  04/QLabs/ 04/QLabs/  Explore more contact usWe are always ready to take your requests QPS Engineering AG Backoffice Phone +41 56 281 91 14 Our Location +41 56 281 91 14 Schaffhauserstrasse 30 4332 Stein, Switzerland Email info@qpsag.com Social network info@qpsag.com X-twitter Linkedin-in Youtube Instagram #### Team teamThe Neural Network experts: uniting talent for intelligent solutions Awesome team members 0 + QPS Sergej RuppelLead Engineer & Managing Director (CEO) / Artificial Intellegance in shaping the future of technology. / Artificial Intellegance in shaping the future of technology.  Working withNeuro has been a game-changer for our business. Their AI solutions have revolutionized our operations, enabling us to automate repetitive tasks and make data-driven decisions with ease. We couldn't be happier with the results."John AndersonCEO of XYZ CompanyWorking withNeuro has been a game-changer for our business. Their AI solutions have revolutionized our operations, enabling us to automate repetitive tasks and make data-driven decisions with ease. We couldn't be happier with the results."John AndersonCEO of XYZ Company testimonialsHear what our customers say about our AI solutions Happy clients 0 + awardsCelebrating our award-winning achievements 2021 Site of the day NLPGenius: Natural Language Processing Powered by Neural Networks 2021 Best animation SmartTrader: Predictive Stock Market Analysis using Neural Networks 2022 Site of the day HealthCareAI: Personalized Diagnostics and Treatment Recommendations with Neural Networks 2023 Video Splash AutoDrive: Autonomous Vehicle Navigation with Advanced Neural Networks get in touchWe are always ready to help you and answer your questions Pacific hake false trevally queen parrotfish black prickleback mosshead warbonnet sweeper! Greenling sleeper. Call Center 800 100 975 20 34+ (123) 1800-234-5678 Our Location 800 100 975 20 34+ (123) 1800-234-5678 USA, New York – 1060Str. First Avenue 1 Email neuros@mail.co Social network neuros@mail.co Facebook-f X-twitter Linkedin-in Youtube #### Thank You We will contact you soon. #### Typography Heading 1 - 80px Heading 2 - 60px Heading 3 - 40px Heading 4 - 30px Heading 5 - 25px Heading 6 - 20px Halosaur duckbilled barracudina, goosefish gar pleco, chum salmon armoured catfish gudgeon sawfish whitefish orbicular batfish mummichog paradise fish!Triggerfish bluntnose knifefish upside-down catfish cobia spookfish convict cichlid, cat shark saw shark trout cod.” Pacific hake false trevally queen parrotfish black prickleback moss. Pacific hake false trevally queen parrotfish black prickleback moss Halosaur duckbilled barracudina, goosefish gar pleco, chum salmon armoured catfish gudgeon sawfish whitefish orbicular batfishTriggerfish bluntnose knifefish upside-down catfish cobia spookfish convict cichlid, “cat shark; saw shark trout cod.” Pacific hake false trevally queen parrotfish black prickleback moss. Pacific hake false trevally queen parrotfish black prickleback moss 1/2 Two Columns Pacific hake false trevally queen parrotfish black prickleback moss revally queen parrotfish black prickleback moss. Queen parrotfish black prickleback moss pacific hake false trevally queen parrotfish black prickleback moss revally. Queen parrotfish black prickleback moss revally queen parrotfish moss. Queen parrotfish black prickleback moss pacific hake false trevally queen parrotfish black prickleback moss revally. Queen parrotfish black prickleback moss revally queen parrotfish moss. Queen parrotfish black prickleback moss pacific hake false trevally queen parrotfish black prickleback moss revally 1/3 Three Columns Pacific hake false trevally queen parrotfish black prickleback moss revally queen parrotfish black prickleback moss. Queen parrotfish black prickleback moss pacific hake false trevally queen Queen parrotfish black prickleback moss pacific hake false trevally queen parrotfish black prickleback moss revally. Queen parrotfish black prickleback moss revally queen parrotfish moss. Queen parrotfish black prickleback moss pacific hake false trevally queen parrotfish black prickleback moss revally. Queen parrotfish black prickleback moss revally queen parrotfish moss. 1/4 Four Columns Queen parrotfish black prickleback moss pacific hake false trevally queen parrotfish black prickleback moss revally. Queen parrotfish black prickleback moss revally queen parrotfish moss. Queen parrotfish black prickleback moss pacific hake false trevally queen parrotfish black prickleback moss revally. Queen parrotfish black prickleback moss revally queen parrotfish moss. Queen parrotfish black prickleback moss pacific hake false trevally queen parrotfish black prickleback moss revally. Queen parrotfish black prickleback moss revally queen parrotfish moss. Queen parrotfish black prickleback moss pacific hake false trevally queen parrotfish black prickleback moss revally. Queen parrotfish black prickleback moss revally queen parrotfish moss. Artificial Intelligence refers to the development of computer systems that can perform tasks that would typically require human intelligence. It involves the creation of algorithms and models that enable machines to learn, reason, perceive, and make decisions. Blockquotes Artificial Intelligence refers to the development of computer systems that can perform tasks that would typically require human intelligence. It involves the creation of algorithms and models that enable machines to learn, reason, perceive, and make decisions. Style list Pacific hake false trevally queen parrotfish blackPrickleback moss revally queen parrotfish blackQueen parrotfish black prickleback moss pacificHake false trevally queen Pacific hake false trevally queen parrotfish blackPrickleback moss revally queen parrotfish blackQueen parrotfish black prickleback moss pacificHake false trevally queen get in touchWe are always ready to help you and answer your questions Pacific hake false trevally queen parrotfish black prickleback mosshead warbonnet sweeper! Greenling sleeper. Call Center 800 100 975 20 34+ (123) 1800-234-5678 Our Location 800 100 975 20 34+ (123) 1800-234-5678 USA, New York – 1060Str. First Avenue 1 Email neuros@mail.co Social network neuros@mail.co Facebook-f X-twitter Linkedin-in Youtube ### Projects #### Computerized System Validation Support In this project, QPS Engineering supported a pharmaceutical client in validating a newly introduced computerized system used in a GMP-regulated production environment. The scope covered the full CSV lifecycle, from initial system assessment to audit-ready documentation. Our team developed a comprehensive, risk-based validation strategy based on GAMP 5 principles, ensuring full compliance with EU Annex 11 and 21 CFR Part 11. We collaborated closely with QA, IT, and system vendors to define user requirements, assess supplier documentation, and implement a traceable validation process. Through detailed planning and efficient execution, QPS delivered a fully validated system that passed inspection without observations and integrated smoothly into the client’s existing quality management framework. Scope of Services Gap analysis and vendor audit Validation Master Plan (VMP) URS, FS, DS creation based on business and regulatory needs Risk assessment (RA), traceability matrix, and test plan design Execution of IQ/OQ/PQ protocols Data integrity assessment and backup/restore verification Final report and audit preparation package #### Product Transfer of different Filling Line This project involved the successful GMP-compliant transfer of pharmaceutical products between two distinct aseptic filling lines. The objective was to ensure process consistency, product integrity, and regulatory compliance while adapting to different technical setups and machine configurations. QPS Engineering led the full lifecycle of the product transfer, from feasibility analysis and risk assessment to the execution of media fills and performance qualification (PQ). A detailed comparability study was conducted to validate that critical quality attributes remained unaffected by the line change. Scope of Services: Risk-based feasibility study and gap analysis between both lines Execution of validation protocols including media fills and process simulations Definition and adjustment of format parts and process parameters Documentation support for change control and regulatory readiness #### Qualification Fill and Finish This project involved the full GMP qualification of a complete fill and finish process line, including upstream preparation, aseptic filling, and final container closure. The objective was to commission and qualify the system for clinical and commercial production of sterile drug products. QPS Engineering managed the entire project lifecycle from FAT/SAT coordination through to IQ, OQ, and PQ execution on-site. The scope covered vial washing tunnels, sterilization tunnels, filling machines, isolator systems, and capping stations. Particular focus was placed on achieving contamination control, cleanroom integration, and operator protection. Our team developed all required qualification documentation based on client-specific SOPs and GAMP 5 principles, including risk assessments, test protocols, and final reports. We supported media fills, alarm testing, and ensured traceability of critical parameters across the full process. Scope of Services FAT/SAT witnessing and documentation review Installation Qualification (IQ) of all fill-finish equipment Operational Qualification (OQ) with challenge tests and alarm simulations Performance Qualification (PQ) with process simulation (media fills) Integration of environmental monitoring and cleanroom classification GMP documentation package including risk-based traceability matrix Regulatory inspection support #### Qualification LYO for Big Batch Sizes This project focused on the qualification of a large-scale freeze dryer (lyophilizer) designed to process high batch volumes of parenteral drug products. The goal was to ensure GMP-compliant installation, operation, and performance of the equipment under real production conditions, with a particular emphasis on load capacity, uniformity of drying, and integration into existing cleanroom infrastructure. QPS Engineering oversaw the entire qualification lifecycle, including the definition of User Requirements Specifications (URS), execution of IQ, OQ, and PQ protocols, and the coordination of loading system validation. Special attention was given to shelf temperature mapping, vacuum control, condenser performance, and product chamber uniformity to ensure consistent drying across the full batch size. The project also included cycle development support and test runs using placebo product to simulate real loads. Final documentation was compiled in alignment with GAMP 5 and EU GMP Annex 1 guidelines for sterile manufacturing. Scope of Services URS definition and vendor alignment Installation and commissioning of large-scale freeze dryer (HOF system) IQ/OQ execution including shelf mapping and system alarms Performance Qualification (PQ) using placebo vials at maximum load Integration with isolator, loading system, and clean utilities Development support for robust and scalable freeze-drying cycles Final qualification report and audit support package #### Qualification of AVI Syringes and Vials This project involved the GMP-compliant qualification of an Automated Visual Inspection (AVI) system for prefilled syringes and vials. The objective was to enhance the detection accuracy for particulate and cosmetic defects while ensuring full compliance with regulatory requirements. QPS Engineering was responsible for the complete qualification strategy, including risk assessments, IQ/OQ planning and execution, and the validation of the image processing system. A key focus was the integration of modern AI-based defect recognition algorithms, implemented seamlessly into the existing production line without modifying its structure. Scope of Services: GMP-compliant qualification (IQ/OQ) of AVI systems for syringes and vials Design and execution of a comprehensive reference defect program Integration of AI-driven image processing to improve detection capabilities Support during regulatory inspections and audit preparation #### Sterilisation of Systems This project involved the qualification and validation of sterilization procedures for complex pharmaceutical manufacturing systems, including product-contact equipment, transfer lines, vessels, and isolators. The main objective was to ensure microbiological integrity and reproducible sterility across all critical components prior to aseptic manufacturing. QPS Engineering led the definition of sterilization strategies based on system design, material compatibility, and regulatory requirements. This included development and execution of moist heat sterilization cycles (autoclave and SIP), dry heat sterilization (DHS), and H₂O₂ vapor sterilization within isolators. Comprehensive biological and chemical indicator studies were conducted to verify lethality and uniformity of sterilization. The qualification followed a risk-based approach and was documented according to EU GMP Annex 1 and ISO 14937 standards. Scope of Services Definition of sterilization strategy per equipment and material type Development and qualification of SIP and H₂O₂ cycles Thermocouple mapping and cold spot identification Use of biological indicators (BI) and chemical indicators (CI) Alarm testing, system hold-time studies, and requalification planning Final reporting for internal QA and regulatory inspections #### Testset Manufacturing This project focused on the GMP-compliant design and manufacturing of customized test sets used for visual inspection system qualification. The test sets simulate realistic defect scenarios in syringes, vials, and ampoules to support Manual, Semi-Automated, and Automated Visual Inspection (MVI, SAVI, AVI) processes. QPS Engineering managed the full process from defect design and feasibility studies to controlled manufacturing, documentation, and delivery. The defects included particle contamination, glass cracks, cosmetic flaws, fill level deviations, and stopper issues—produced under validated and traceable conditions. The test sets are now being used in operator training, system qualification, and requalification campaigns across various sterile manufacturing facilities in Europe. Scope of Services Design and simulation of real-life defect scenarios GMP-compliant manufacturing of test containers (vials, syringes, ampoules) Documentation of defect type, location, and severity per item Labeling, packaging, and transport validation Custom defect libraries tailored to customer-specific inspection needs Ongoing support for test set lifecycle management and traceability #### Visual Inspection This project focused on the implementation and qualification of visual inspection systems for parenteral drug products, including prefilled syringes, vials, and ampoules. The goal was to ensure reliable defect detection—both cosmetic and particulate—while meeting strict GMP and Annex 1 requirements. QPS Engineering supported the entire process: from defining the inspection strategy and creating defect libraries to qualifying equipment and training operators. Manual (MVI), Semi-Automated (SAVI), and fully Automated Visual Inspection (AVI) systems were all covered. We provided tailored solutions for each system type, including lighting optimization, camera calibration, and test kit preparation. Operator qualification procedures were also implemented to ensure consistent inspection performance in routine production. Scope of Services Development of GMP-compliant inspection strategies (MVI, SAVI, AVI) Design and qualification of reference defect libraries IQ/OQ execution of visual inspection systems Operator qualification programs and training materials System calibration and performance verification Audit support and documentation package ### Services #### QEngineering QENGINEERING BY QPS ENGINEERING AG Engineering Excellence for Pharma & Biotech We design, optimize, and qualify pharmaceutical and biotechnological systems — fully GMP-compliant, risk-based, and driven by deep process understanding. Start Your Project Talk to an Expert ISO 9001 certified GMP integrated engineering Full lifecycle support ↓ Scroll to learn more ENGINEERING FOR REGULATED INDUSTRIES Precise, GMP-Aligned, and Future-Ready Engineering QEngineering delivers end-to-end engineering expertise for pharmaceutical, biotech, and high-potent production environments. From concept to commissioning, we ensure technical integrity, regulatory compliance, and long-term operational excellence. Our multidisciplinary team combines process engineering, automation, facility design, and validation expertise. We work closely with your stakeholders to deliver solutions that are technically robust, inspection-ready, and optimized for operational efficiency—whether you're building a new facility, upgrading existing systems, or preparing for regulatory audits. GMP-oriented design Risk-based engineering Integrated EPCMQV execution Short inquiry – we get back to you Send us a brief request about your project. We respond with a first assessment and next steps within 1–2 business days. Name E-mail Area of interest Please select… Pharma process engineering Biotech process engineering Project & lifecycle management Qualification & validation Project in 1–2 sentences (optional) Send inquiry We process your data according to GDPR / Swiss data protection law and only use it to respond to your request. OUR CORE SERVICES Engineering solutions for complex pharma & biotech projects From system initialization to lifecycle documentation — QEngineering supports you across the entire project lifecycle with robust, GMP-aligned engineering services. System Services System Initialization & Testing Ensure a seamless startup and robust performance through structured commissioning, testing, and qualification protocols. Discuss system startup Process Analyses Process Analyses for Quality Engineering Identify optimization potential, improve long-term reliability, and increase efficiency through engineering-driven assessments. Improve process reliability Project Support Project & Process Engineering Support Strengthen your project execution with reliable engineering oversight, aligned to timelines, costs, and regulatory expectations. Get project support CSV & Studies Qualification, Validation & Technical Studies GAMP 5–aligned validation strategies to qualify systems and processes in accordance with global GMP standards. Plan validation strategy Documentation Documentation & Audit Services Inspection-ready documentation and audit support to maintain lifecycle compliance and regulatory transparency. Secure documentation support Pharma Engineering Pharma Process Engineering Solutions for sterile, high-potent, OSD, BFS, and contained manufacturing environments — integrated, safe, and scalable. Explore pharma solutions PHARMA & BIOTECH ENGINEERING From concept to qualification – with one engineering partner We support your projects across the entire lifecycle: from feasibility and concept studies to detailed design, execution, commissioning, and qualification. Our approach combines technical depth, GMP integration, and structured risk management. Feasibility & concept studies for pharma and biotech facilities Basic & detailed design with integrated GMP and safety requirements Execution and commissioning with structured documentation and testing Qualification & validation aligned with GAMP 5 and global GMP GMP integrated by design Compliance is embedded into every engineering decision — not added at the end. Risk-based approach We identify technical and regulatory risks early and align mitigation plans with your stakeholders. ISO 9001 certified Quality management and documentation standards you can rely on in audits and inspections. Continuous improvement Lessons learned and best practices continuously feed back into your next project phase. CONTACT Ready to start your engineering project? Share a few details about your system, facility, or project. Our QEngineering experts will contact you with a structured response and proposed next steps. Company Name E-mail Phone (optional) Service area Please select… Pharma process engineering Biotech process engineering EPCMQV project management Qualification & validation Documentation & audit support Project description I agree that QPS Engineering AG may process my data for the purpose of handling my inquiry. I have read the privacy policy. Send detailed inquiry You receive a confirmation and a personal response from our QEngineering team, usually within 1–2 business days. #### QLabs QLABS BY QPS ENGINEERING AG — PRODUCTS, AUDITS & TRAINING Optimize the Performance & Reliability of Your Inspection Processes QLabs develops custom DiS test sets, defect catalogs, and maintenance programs for manual, semi-automated, and automated visual inspection — ensuring your processes reliably detect particles and defects, satisfy GMP requirements, and pass audits. Request Test Sets Learn More About QLabs ISO 9001 & ISO 14001 certified Pharma & Biotech focus GMP / GxP-compliant solutions Made in Switzerland ↓ Scroll to explore TEST SETS & DEFECT CATALOGS The Cornerstone of Visual Inspection QLabs specializes in the development of custom test sets that are decisive for qualification and validation across Manual Visual Inspection (MVI), Semi-Automated Visual Inspection (SAVI), and Automated Visual Inspection (AVI). Our customer-specific DiS (Defect Imitation Sample) test sets are fundamental to developing and optimizing inspection systems, qualifying operators effectively, and strengthening their ability to detect defects. They secure reliability and precision in real production environments — a key factor for consistently high-quality inspection. MVI, SAVI & AVI solutions GMP-compliant test sets Audit-ready documentation Quick inquiry — we'll get back to you Send us a brief request about your project. We respond with an initial assessment and next steps within 1–2 business days. Name E-mail Area of interest Please select… DiS test sets Defect catalogs (vials / syringes) Maintenance & servicing Training & audits Qualification & validation Project in 1–2 sentences (optional) Send inquiry We process your data according to GDPR / Swiss data protection law and only use it to respond to your request. VISUAL INSPECTION BASICS Why visual inspection matters In the pharmaceutical industry, visual inspection is critical for ensuring product quality and safety. It is an indispensable tool for identifying particles and other defects, guaranteeing that products meet the highest quality standards and the requirements of patient safety. Effective inspection requires more than trained inspectors — it depends on appropriate test sets and adherence to strict regulations. Test sets serve three core purposes in this process: Training — new inspectors build expertise in recognizing defects. Qualification — inspectors and systems regularly demonstrate their detection performance against defined test-set standards. Validation — manual inspector competence and automated system accuracy are confirmed against required quality standards. OUR CORE SERVICES Building blocks of visual inspection with QLabs QLabs combines defect catalogs, custom test sets, training and audits, and ongoing maintenance to sustainably ensure the performance and reliability of your inspection processes. Products Defect Catalogs The foundational document listing defect types to identify problems and improve product and process quality. Available for vials and syringes — and the basis on which we produce individual test sets. Request defect catalog info DiS Test Sets Custom Test Sets Customer-specific Defect Imitation Sample sets for qualifying operators and equipment, validating systems, and reducing the False Reject Rate to cut costs and improve productivity. Get DiS test set quote Services Training & Audits Systematic operator training built on our defect catalogs and test sets, plus audit preparation and support — so your team and your documentation are ready when inspectors arrive. Plan training or audit support Maintenance Servicing & Upkeep Cleaning, periodic inspection, and a reserve pool of replacement samples keep your test sets qualified and reliable. Send your sets to our experts for professional review and renewal. Discuss maintenance contracts OUR TEST SETS IN DETAIL Four test set types for every inspection need Our test sets are built on standardized conditions and reference samples, ensuring the comparability and reproducibility of inspection results across operators and equipment. Function Check Fuko Test Set Verifies the functionality and operational readiness of equipment and systems. Use: Confirms all components and systems work as intended and meet required performance criteria, identifying and resolving malfunctions before they escalate. Probabilistic DiS Probabilistic Defects Assesses the ability of operators and systems to identify non-deterministic particles and defects. Use: Detection-rate determination, operator and equipment qualification, and identifying weak points in inspection systems and processes — supporting proactive risk minimization. Static DiS Static Defects Systematically identifies and analyzes static, fixed-position defects on products. Use: Packaging-material control, container inspection for cracks or deformation, and detection of cosmetic defects outside tolerance — safeguarding product integrity and quality. System Test ST System Test Checks the accuracy and reliability of camera systems and optical components. Use: Verifies imaging systems used to inspect medications, packaging, and labelling work precisely, plus maintenance and integrity of optical components. REQUIREMENTS IN PHARMA & BIOTECH PRODUCTION Why pharmaceutical manufacturers rely on test sets The need for individual test sets arises from several critical industry requirements. They ensure that all quality-relevant processes meet strict GMP standards and deliver consistent, high-quality results. Regulatory compliance GMP compliance is not optional but mandatory. Test sets let manufacturers demonstrate adherence effectively and pass audits successfully. Quality assurance Where product quality directly affects consumer health and safety, qualifying equipment and processes guarantees every batch meets the required standards. Risk minimization Test sets help identify and minimize production risks — including contamination and process errors — that could compromise product quality. Efficiency gains Optimization reduces the False Reject Rate, avoids costly false rejections, lowers quality costs, and improves productivity and profitability. MAINTENANCE & UPKEEP Regular maintenance — lasting reliability Regular maintenance of test sets is decisive for ensuring their lasting performance and reliability. This critical step keeps your inspection processes aligned with the highest quality standards over time. 1 Sample cleaning Careful cleaning prevents false detections caused by contamination rather than actual product defects — so results are based purely on real defects. 2 Sample verification Periodic checks ensure samples retain their qualification status, show no wear, avoid double defects, and accurately reflect every documented defect. 3 Reserve sample pool A reserve pool allows fast, efficient replacement of any disqualified sample, keeping test sets fully operational at all times. 4 Professional service Send your test sets to our experts for thorough inspection and replacement of worn samples, keeping them at current technical and quality standards. DEFECT CATALOGS — VIALS & SYRINGES Detect defects consistently, by regulation A defect catalog is a foundational document — in industry and pharma alike — that lists defect types to identify problems and improve product and process quality, safety, and efficiency. It supports quality assurance by catching issues early, helps optimize processes to reduce costs, improves operator training and risk management, and ensures regulatory compliance and patient safety. We offer dedicated catalogs for: Vials — overview of vial defects for fault identification Syringes — overview of syringe defects for fault identification On the basis of these catalogs, we produce the individual test sets used for systematic operator training and objective assessment of inspection systems. Audit-ready documentation Support with qualification and validation documents aligned with current GMP / GxP requirements. ISO-certified processes QPS Engineering AG is ISO 9001 and ISO 14001 certified — ensuring structured, traceable workflows. Pharma & Biotech focus Experience with aseptic lines, high-volume inspection, and demanding audits. Strong team, close to customers A dedicated team delivering great results — with short lines of communication and close collaboration on every project. CONTACT Ready to enhance your visual inspection? Share details about your system, facility, or project. Our QLabs experts will contact you with a structured response and proposed next steps. QPS Engineering AG, Schaffhauserstrasse 30, 4332 Stein, Switzerland +41 56 281 91 14 info@qps-engineering.ch Company Name E-mail Phone (optional) Service area Please select… DiS test sets Defect catalogs Training & qualification Maintenance & servicing Validation support Audit preparation Project description I agree that QPS Engineering AG may process my data for the purpose of handling my inquiry. I have read the privacy policy. Send detailed inquiry You receive a confirmation and a personal response from our QLabs team, usually within 1–2 business days. #### QMeasure QMEASURE BY QPS ENGINEERING AG Precision Measurement Services for Quality Assurance We deliver high-precision measurement services tailored to pharmaceutical, biotechnology, and food technology industries. Our expertise in illuminance, noise level, roughness, non-destructive testing, and temperature mapping ensures accurate, reliable, and compliant quality assurance. Request Measurement Services Explore Our Services ISO 9001 certified Calibrated equipment GxP-compliant documentation ↓ Scroll to learn more PRECISION MEASUREMENT SOLUTIONS Accurate, Reliable, and Compliant Measurements QMeasure specializes in delivering comprehensive measurement services that support your quality assurance processes in regulated environments. From environmental monitoring to material testing, we ensure your measurements meet the highest standards. Our team uses calibrated equipment and follows strict protocols to provide traceable, audit-ready documentation for all measurement activities, helping you maintain compliance and operational excellence. Temperature mapping Environmental measurements Material testing Quick inquiry — we'll get back to you Send us a brief request about your measurement needs. We respond with an initial assessment and next steps within 1–2 business days. Name E-mail Measurement type Please select… Temperature mapping Illuminance measurement Noise level measurement Roughness testing Non-destructive testing Project in 1–2 sentences (optional) Send inquiry We process your data according to GDPR / Swiss data protection law and only use it to respond to your request. OUR MEASUREMENT SERVICES Comprehensive solutions for quality assurance QMeasure offers a complete range of measurement services designed to support your quality assurance processes in pharmaceutical, biotech, and food technology facilities. Critical Services Temperature Mapping & Qualification Comprehensive temperature mapping for storage areas, refrigerators, freezers, incubators, and manufacturing spaces. Full qualification documentation for regulatory compliance. Request temperature mapping Environmental Monitoring Illuminance & Noise Level Testing Precise measurement of lighting conditions and noise levels to ensure compliance with workplace safety standards and optimal working conditions in cleanrooms and production areas. Get environmental assessment Material Analysis Roughness & Non-Destructive Testing Surface roughness measurement and non-destructive testing (NDT) to verify material quality, detect defects, and ensure compliance with specifications without damaging the product. Schedule material testing PRECISION & COMPLIANCE Why precision measurement matters in regulated industries In pharmaceutical and biotechnology manufacturing, precise measurements are not just about quality — they're about patient safety, regulatory compliance, and operational reliability. QMeasure ensures that every measurement is performed with calibrated equipment, documented according to GxP requirements, and delivered with full traceability. Our services support: Qualification and validation of facilities and equipment Ongoing monitoring and periodic re-qualification Audit preparation and regulatory inspection support Troubleshooting and process optimization All measurements are conducted by trained specialists using calibrated instruments with traceable certification, ensuring your data stands up to the most rigorous audits. Calibrated equipment All measurement instruments are regularly calibrated with traceable certification to international standards. GxP-compliant documentation Complete documentation packages that meet FDA, EMA, and other regulatory requirements. ISO 9001 certified QPS Engineering AG maintains ISO 9001 certification for consistent, quality-focused processes. Expert team Specialists with deep knowledge of pharmaceutical and biotech measurement requirements. CONTACT Ready to ensure measurement precision? Share details about your facility, equipment, or measurement needs. Our QMeasure experts will contact you with a structured proposal and timeline. Company Name E-mail Phone (optional) Measurement service Please select… Temperature mapping & qualification Illuminance measurement Noise level assessment Surface roughness testing Non-destructive testing (NDT) Comprehensive measurement package Project description I agree that QPS Engineering AG may process my data for the purpose of handling my inquiry. I have read the privacy policy. Send detailed inquiry You receive a confirmation and a personal response from our QMeasure team, usually within 1–2 business days. #### QxTec QxTec Solutions Advanced Robotics, AI & Visual Inspection Solutions QxTec delivers end-to-end inspection and digital transformation solutions — from automated and manual visual inspection to robotic systems and AI-driven business tools — all tailored to the pharmaceutical, biotech, and food technology industries. Automated Visual Inspection RAVI-720 Robotic automated visual inspection that combines vision systems, AI defect detection, and precise robotic handling to identify particulate and cosmetic defects in vials, syringes, ampoules, and cartridges — earlier and more consistently than manual checks. Explore RAVI-720 Manual Visual Inspection MVI – Quantum Hoods & Booths Manual and semi-automatic inspection hoods and booths for particulate and cosmetic defect detection of parenteral products. With MVI Tracker, inspectors gain actionable, GxP-compliant intelligence on incoming defects and a powerful training tool for new operators. Discover hoods & booths Robotics & Automation Robotic Solutions Integration of cutting-edge robotic systems to automate repetitive tasks, improve precision, reduce variability, and maximize output quality across production and laboratory environments in regulated industries. Discuss robotic solutions Artificial Intelligence AI Business Tools Custom AI solutions for predictive maintenance, quality analysis, process optimization, and data-driven decision making — turning your operational data into actionable intelligence and measurable business value. Explore AI business tools OUR INNOVATION APPROACH From concept to production-ready solutions QxTec doesn't just develop technology — we partner with you to understand your challenges, prototype solutions, and deploy systems that create measurable value. Our approach combines agile development with deep industry knowledge: Discovery Phase: Understanding your processes, pain points, and opportunities Proof of Concept: Rapid prototyping to validate technical feasibility Development: Building robust, scalable solutions with clean code Integration: Seamless deployment into your existing infrastructure Training & Support: Empowering your team to operate and scale solutions All our solutions are designed with regulatory compliance in mind, ensuring they meet GxP requirements while pushing the boundaries of what's possible. AI-first mindset We leverage the latest AI technologies to solve complex problems with intelligent, adaptive solutions. Custom development Every solution is tailored to your specific needs, technical environment, and business objectives. Regulatory expertise Deep understanding of GxP requirements ensures compliant innovation from day one. Scalable architecture Modular, future-proof systems that grow with your business and adapt to changing needs. CONTACT Ready to innovate with AI & robotics? Share your digital transformation vision with us. Our QxTec experts will contact you with innovative ideas and a roadmap to bring them to life. Company Name E-mail Phone (optional) Innovation area Please select… AVI-Rovis (automated visual inspection) MVI – Quantum hoods & booths Robotic solutions AI business tools Innovation challenge I agree that QPS Engineering AG may process my data for the purpose of handling my inquiry. I have read the privacy policy. Send innovation inquiry You receive a confirmation and a personal response from our QxTec innovation team, usually within 1–2 business days.