This short video explains, in simple terminology,
what Computer System Validation is,
and how it saves your company money!

Lab5 - Webdesign Schweiz 

Thanks for the report and the references to the EDC vendors. I greatly appreciate your dedication and professionalism and learned a  lot from you on how to audit. I think you did a great job there and I sincerely hope that we will continue working together.

– Pharmaceutical Company
Reykjavik, Iceland

David's Books

One of the nation's foremost experts on CSV for 21 CFR Part 11, David Nettleton has written several books with Janet Gough, including:

Software as a Service - Risk-Based Validation with Time-Saving Templates

Software as a Service
Risk-Based Validation
with Time-Saving Templates

NEW for 2020!

Managing the Documentation Maze
Managing the Documentation Maze

Electronic Record Keeping
Electronic Record Keeping
Achieving and Maintaining
Compliancewith 21 CFR Part 11 and
45 CFR Parts 160, 162, and 164

See the Books page for more information and to order.