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

Lab5 - Webdesign Schweiz 

http://www.datstat.com/edc

DatStat offers a validated EDC/CDMS that’s perfect for sponsors, CROs, and investigators seeking real-time interactions with their patients, research participants, and providers. Our platform includes best-in-class eCRFs, multi-site and multilingual support, remote (offline) data capture, cross-form validations, and nested eCRFs. Ideal for PROs and post-market surveillance surveys. DatStat clients get exceptional data quality, unmatched functionality, DIY forms, and expert support at an affordable cost, so they can deliver improved health outcomes around the world. Based in Seattle, WA since 1997.

 

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.