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

Lab5 - Webdesign Schweiz 

This course provides in depth study of document control systems. It is applicable to all types of companies, especially those with government, legal, and regulatory oversight. It is intended for managers and documentation specialists. Most important, participants will learn how to evolve their current systems to increase productivity and effectively managed electronic and paper documents.

1-FDA and Document Record Keeping Systems (DRKS)

2-Technologies for Document Management

3-Data Migration Strategies

4-Introduction: Understanding responsibilities

5-IT Responsibilities

6-QA Responsibilities

---end of day one---

7-Document Control Responsibilities

8-Keeping Up-To-Date with Industry Standards for DRKS

9-HIPAA Compliance for DRKS

10-Managing Information

11-System Changes and Upgrades

---end of day two---

David's Books

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
Risk Based Software Validation - Ten easy Steps

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

Managing the Documentation Maze
Managing the Documentation Maze
Read a Review

Commercial Off the Shelf COTS Software Validation
Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance

See the Books page for more information and to order.