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

Lab5 - Webdesign Schweiz 
  • 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

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.