GageList Software Validation Documents

For Compliance with FDA Regulations and Guidance


GageList conducts regular software validations and provides an available Software Validation Kit that supports compliance with FDA requirements.

The FDA requires that the software you use for managing the various aspects of your quality program be validated. Validation means documenting the evidence affirming that the software you use to support product quality and safety meets users’ needs and functions in accordance with its intended use. Request Validation Kit below.

With some exceptions, these requirements apply to food and beverage manufacturers, biotech companies, drug manufacturers, biologics developers, medical device manufacturers, CROs, and other FDA-regulated industries. Such companies are required to implement controls such as audit procedures, audit trails, software validations, electronic signatures, and documentation for systems used in processing the data that the FDA requires them to maintain.


GageList Software Validation Resources

As part of our commitment to meeting the critical quality requirements of the food, pharma and biotech industries, GageList offers customers a comprehensive Software Validation Kit that includes:

  • Up-to-date Internal Validation Test Results
  • Validation Statement
  • Validation Procedure Sample
  • Validation Test Template


To request a GageList Validation Kit or to learn more about how we support compliance with FDA requirements or any other standards, please reach out to our customer support team any time.