21. ISPE GAMP 5 in der Praxis
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... teilweise auch recht komplex wirken, da für jedes spezifische Teilgebiet bereits Expertenwissen vorhanden sein muss. Nicht nur im Pharma- und Medizinproduktebereich werden viele IT-Projekte immer noch ...

22. About
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... biological, biotechnology, healthcare and medical device industry. Our consultants are themselves from the industry and have the education, knowledge and hands-on personal experience and validation expertise ...

23. Focused Solution Packages (FSP)
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... run a Mock (Pre-Audit) up-front and implement corrective actions and strategies. We can also set up a team of different auditors for you: native speakers, special topics experts, qualified persons, etc. ...

24. Terms & Conditions
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... we cannot settle amicably relating to the nature or quality of the services will be referred to an expert to be agreed. The written report of the expert will as between you and us be conclusive evidence ...

25. Code of Ethics
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... we work and live. A healthy planet and a healthy community go hand in hand. Our satisfaction guarantee:   You get 12 months of free expert advice to help prepare and protect you when any auditor ...

26. HP Quality Center
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... Plan: Specify your test specification and script, prepare test data and test environment, link test cases to requirements, create a test execution order, assign testers (subject matter experts) for each ...

27. Compliance Management
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... like PMBOK, Prince2, ISO 12207, ISPE GAMP and Good Practice Guides, CMMI, Scrum or ITIL, and we choose the right strategy and extent for your business needs. We are recognized subject matter experts for ...

28. CCS Network
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... for interaction and partnerships between different subject matter experts, test, and validation specialists, IT solution providers, tool and application advisors, and compliance consultants and stimulate ...

29. Compliance Proposal
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... shown up? Clients work directly with our Managing Director and Principal, Markus Roemer, a globally recognized expert on IT projects and computer system validation.   Markus Roemer is: an active ...

30. Select the result you want:
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... efficient tool implementation and long-term strategies. Rapid, expert response to audit results, inspections, observations, or warning letters: Require audit support, corrective actions? Need assistance ...