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')

... 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 achieved by analysing and ...

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)

... 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 achieved by analysing and ...