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GAMP 5 - Good Automated Manufacturing Practice

MasterControl's Quality Management Systems are designed by industry practitioner for automating the GAMP 5 process in any organization. A Quality Management Software system is the crux of any quality and compliance process. It is a regulatory requirement that FDA / global regulatory inspectors and ISO auditors consider critical. An automated GAMP 5 system reduces audit time and findings, and a decreases risk of product recalls. It improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.


Watch Videos: Learn More About GAMP 5

Download Free GAMP 5 Resources

Educational Materials

Get insider information about the most relevant issues in Manufacturing today, and how to navigate and overcome the complexities of GAMP 5.

Produktdatenblätter
White Paper
  • Qualitätsmanagementlösungen können Unternehmen unnötige – und oftmals horrende – Kosten für schlechte Qualitätprozesse ersparen. Erfahren Sie, wie Marktführer QMS-Software einsetzen, um für strategischere und nachhaltigere Verbesserungen des Qualitätssystems zu sorgen.
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Analyst Report
  • Marktführende Hersteller verabschieden sich zunehmend von veralteten, nicht integrierten Qualitätsmanagementlösungen. Erfahren Sie, warum geschlossene, von QMS-Technologie gestützte Qualitätsprozesse nachweisbare Auswirkungen auf die Qualitätsleistung eines Hersteller haben.

Produktinformationen

Discover how MasterControl Quality Management System can manage your GAMP 5 process, all while mitigating risk, improving speed-to-market, and generating ROI.

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Produktdatenblätter
Produktdatenblätter
Fragen und Antworten

Toolkits & Demos

Holen Sie sich detaillierte, umfassende Ressourcen, die Sie bei der Entwicklung Ihres CAPA-Softwareprogramms unterstützen.

Produktdatenblätter
Interaktive und Live-Demonstrationen
  • Das Qualitätsmanagementsystem (QMS) von MasterControl bietet eine breite Palette an Softwarelösungen für Qualitätsmanagement, Dokumentenlenkung, Produktlebenszyklusmanagement, Lieferantenmanagement, Auditmanagement, Schulungsmanagement und weitere, auf Ihre Unternehmensbedürfnisse abgestimmten Lösungen. Dieser Überblick zeigt, wie Sie mit dem QMS von MasterControl Abfall vermeiden, Audits vereinfachen und die Einhaltung behördlicher Vorschriften erleichtern.


How the White Paper about GAMP 5 can help You


The International Society for Pharmaceutical Engineering (ISPE) issued the worldwide release of GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems in March of 2008. The updated manual for GAMP 5 provides guidelines for good automated manufacturing practices that are referenced in markets around the world, including North and South America, Europe, and Japan.

The white paper that you can download above offers GAMP 5 guidelines and offers ideas on how companies can utilize the processes and templates in the updated manual for GAMP 5 to minimize validation efforts and improve by good automated manufacturing practices.

A variety of subjects related to good automated manufacturing practice are covered in detail in the white paper, specifically:

  • A brief history of GAMP
  • The rationale for GAMP 5
  • The driving forces behind GAMP 5
  • A comparison of GAMP 5 and GAMP 4 -- specifically how they differ
  • Tips on how companies can leverage GAMP 5 to their greatest benefit


Five Key Concepts of GAMP 5


The white paper also outlines and explains the five key concepts behind good automated manufacturing practice 5

  • Product and Process Understanding
  • Lifecycle approach within QMS
  • Scalable Lifecycle Activities
  • Science Based Quality Risk Management
  • Leveraging Supplier Involvement

Other highlights of the GAMP 5 manual covered in the white paper include:

  • Clarified roles
  • Flexibility of format and structure
  • Good automated manufacturing practice for suppliers expectations
  • Supplier assessment and more

For More Information on Good Automated Manufacturing Practice - GAMP 5


For more information about GAMP 5, please feel free to contact a MasterControl representative.

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