1. ISPE GAMP 5 in der Praxis
('Uncategorised Content')

ONLY A GERMAN VERSION OF THIS ARTICLE IS AVAILABLE   ISPE GAMP®5 in der Praxis:  IT Qualitätsmanagement für das 21. Jahrhundert   Der GAMP®5 Leitfaden der ISPE (International Society ...

2. Focused Solution Packages (FSP)
('Uncategorised Content')

... responsibilities, deliverables, project tasks, planning. ISPE GAMP®5 Package: If you want to use and implement a more scaleable and risk-based approach for Validation, this is the right focused solution ...

3. HP Quality Center
('Uncategorised Content')

    HP Quality Center used for risk-based computer system validation according ISPE GAMP®5: Release Management: Plan, organize, and manage your Software Releases and Versions, Patch ...

4. Compliance Management
('Uncategorised Content')

... subject matter experts for ISPE GAMP®5 and ASTM E2500. The so called risk-based approach will be based on a Quality Risk Management concept, refer to ICH Q9. A scalable approach to validation can be ...

5. Speeches and Publications
('Uncategorised Content')

  Our managing director, Markus Roemer, maintains an active speaking and publication schedule. He is a gifted speaker who motivates audiences with practical advice and powerful strategies.  All speeches ...

6. ISPE GAMP 5 in der Praxis
(Uncategorised Content)

ONLY A GERMAN VERSION OF THIS ARTICLE IS AVAILABLE   ISPE GAMP®5 in der Praxis:  IT Qualitätsmanagement für das 21. Jahrhundert   Der GAMP®5 Leitfaden der ISPE (International Society ...

7. Focused Solution Packages (FSP)
(Uncategorised Content)

... responsibilities, deliverables, project tasks, planning. ISPE GAMP®5 Package: If you want to use and implement a more scaleable and risk-based approach for Validation, this is the right focused solution ...

8. HP Quality Center
(Uncategorised Content)

    HP Quality Center used for risk-based computer system validation according ISPE GAMP®5: Release Management: Plan, organize, and manage your Software Releases and Versions, Patch ...

9. Compliance Management
(Uncategorised Content)

... subject matter experts for ISPE GAMP®5 and ASTM E2500. The so called risk-based approach will be based on a Quality Risk Management concept, refer to ICH Q9. A scalable approach to validation can be ...