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

Very useful course - I would recommend it to anyone.

– Biotech company
Waltham, MA

David Nettleton
FDA Compliance Specialist, Author

Blood bank donor and manufacturing
Clinical trial; CDMS (all phases)
Corrective action
Computer security
Document control
Electronic Data Capture (EDC); OCR, fax, Web, laptop, and manual
Enterprise Resource Planning (ERP); SAP, QAD, BatchMaster, Infor Syteline, Infor Visual - Reporting Services; Access, Crystal, Cyberquery, Gupta.
Excel spreadsheets developed for regulated applications
Internet billing
Laboratory instruments
LIMS
Manufacturing
Medical device software (full Systems Development Life Cycle)
Medical testing software to detect blood borne viruses
MRI software to detect breast cancer
Nuclear power plant maintenance
Pharmaceutical
Retail software such as Visio and MS Windows operating systems
RFID
Server room moves
Software As A Service (SaaS)
Telephone switch equipment
Toxicology
VMWare, Hyper-V

One of the nation's foremost experts on CSV for 21CFR Part 11, David Nettleton and Janet Gough have written four books:

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

See the Books page for more information and to order.

This short video explains in simple terminologywhat Computer System Validation isand how it saves your company money