Validation: What It Means in an FDA Regulated Environment

Chrys Kyee, Genentech Inc

Even though formal validation may not be required in unregulated environments, many mission-critical applications could benefit from performing some of the same activities required for FDA regulated systems. Validation provides documented evidence showing, with a high degree of assurance, that a system will consistently meet its predetermined requirements. FDA validation is required if the use of the computer system could potentially impact product quality, safety, or efficacy, or if the system is used to support a regulatory submission function. Learn how validation is accomplished by looking at a series of qualification exercises typically prescribed in a Validation Protocol. Take back with you templates for a typical Validation Protocol, including the System Development Review, Installation Qualification, Operational Qualification, Performance Qualification, and Revalidation. See how your review and test practices can benefit from aspects of the rigor required for regulated software.

  • The scope of validation-who, what, when, how, and why
  • Templates and a sample OQ script
  • Good documentation practices as specified for FDA regulated software

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