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Device Validation Forum: Issues with Medical Device Part 11 Electronic Records; Electronic Signatures | IVT

INTRODUCTION As the medical device industry moves toward electronic records (ER) and signatures by in-house systems and/or cloud/web-based systems, and away from paper documentation, 21 Code of Federal Regulations (CFR) Part 11, Electronic Records; Electronic Signatures (ES) verification and validation (V&V) activities and documentation become mandatory. These issues are not only a regulatory/Part 11 concern but also a user/customer concern. These requirements should not be viewed as unnecessary bureaucratic red tape. All industries, not just US Food and Drug Administration-regulated ones,...

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