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 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.