Validation

One of the most challenging aspects of developing 21 CFR Part 11 compliant software is validation. Wyatt Technology has risen to this challenge to make ASTRA a completely validated product:

  • All software development is done under a formal quality system, using a standard software lifecycle model.
  • Documented testing and traceability is performed to demonstrate accuracy, reliability, and consistent intended performance.
  • The ability to discern altered or invalid records is part of the design of ASTRA's database storage.

Ultimately, we understand that the end user must verify that Wyatt Technology has held true to the demands of validation when creating ASTRA. To that end, we welcome audits of the software development process from qualified auditors.

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