ISPE Part 11 Risk Paper

The ISPE submitted this undated paper to FDA as input to FDA’s Drug GMP modernization effort. Some of the concepts in this paper may be helpful to those trying to implement a risk based approach to electronic records as suggested in FDA’s Part 11 Redirection and Draft Scope Guidance.

ISPE Part11 White Paper

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John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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