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

 

still from video watch the CSV Video Now

Download a one-page brochure.


Download the video (>100mb).

Contact

contact email and phone

Random Testimonial

Thanks for the report and the references to the EDC vendors. I greatly appreciate your dedication and professionalism and learned a  lot from you on how to audit. I think you did a great job there and I sincerely hope that we will continue working together.

– Pharmaceutical company
Reykjavik, Iceland

Meet our Founder

David Nettleton
David Nettleton
FDA Compliance Specialist, Author

Why You Need Computer System Validation!
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.
 

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
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.