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

Lab5 - Webdesign Schweiz 

I really enjoyed last week’s COTS Software Validation class.  Thank you for spending a good amount of time on explaining the specifics of 21 CFR Part 11.  This was the area I needed the most help understanding and you did a great job of clearing up any Part 11 questions I had previous to the class.

- Software Quality Engineer

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.