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

Lab5 - Webdesign Schweiz 

"As your consultant I will provide personalized service for each member of your team so they learn how to work together and with computer systems to maximize productivity. I will promote your education and experience so that your company is compliant with regulatory requirements and is self-sufficient."

– David Nettleton

Companies strive to create goals, processes, culture, management, and incentives that build infrastructure. Computer Systems (software) are a dominant and increasing part of business infrastructure. Computer System Validation is process validation and has the following benefits:

  • Excellent Return On Investment (ROI) - Cost of compliance is low with respect to potential loss of intellectual property or other potential losses.
  • Provides documentation required by FDA, other regulatory agencies, and your customers.
  • Maximizes the value of the computer system and the employees that use it.
  • Reduces labor costs by increasing employee efficiency and effectiveness.
  • Enhances project management to ensure projects are implemented on schedule and on budget.
  • Saves money by discovering defects early, before failures occur in production.
  • Reduces risk. Legal liability, not regulatory, is often the most important reason to perform validation. Software is made and used by people so it is guaranteed to be imperfect. Software and process defects increase with software complexity. Having the evidence that computer systems are correct for their purpose and operating properly represents a good business practice.
  • Promotes continual process improvement. Software is constantly evolving to keep up with the increasingly complex needs of the people that use it. Therefore, validation is an ongoing necessity.

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.