For more than 25 years, regulated life sciences companies have been performing FDA Computer System Validation (CSV) to ensure that systems used in the manufacture of regulated drug products and medical devices meet their intended use and satisfy data integrity requirements.

This white paper will cover:

  • What is the Difference Between FDA Computer Software Assurance (CSA) and Computer System Validation?
  • Compliance Solutions for Life Sciences: Intended Use of Computer Software Assurance