This short video explains, in simple terminology, what Computer System Validation is, and how it saves your company money!
Download a one-page brochure.
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After we attended David’s training, we implemented the procedures he recommended, and we just had our first FDA inspection with no 483s.
– International Pharmaceutical CompanyAmman, Jordan
One of the nation's foremost experts on CSV for 21 CFR Part 11, David Nettleton has written four books with Janet Gough:
Risk Based Software Validation - Ten easy Steps
Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164
Managing the Documentation Maze Read a Review
Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance
See the Books page for more information and to order.