FDA Center for Biologics Evaluation and Research released SOPP 8116 “Using Electronic Signatures for Investigational and Marketing Regulatory Document Concurrence/Signoff” Version #4 Effective Date: August 10, 2010. This describes their approach to using electronic signatures for certain regulatory approvals (including correspondence and premarket submissions) and is based on applying each person’s network profile identification via...Read More
Schedule Discussion with John F. Murray, Jr.
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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