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Validation Center

The Validation Center organizes controlled documentation used to evaluate and maintain FlaskTrack for a defined intended use and release.

Document package

A package may include:

  • validation master plan;
  • user requirements specification;
  • functional and design specifications;
  • risk assessment;
  • traceability matrix;
  • installation, operational, and performance qualification documents;
  • validation protocol and report;
  • Part 11 control matrix and applicability assessment;
  • electronic-signature and audit-review procedures;
  • supplier qualification, disaster recovery, migration, periodic review, and retirement documents;
  • vendor release evidence and configuration baseline records.

Review documents

Open a document to review its controlled content and metadata. Uploaded or generated files should be checked for title, owner, scope, status, execution evidence, and required approvals.

Export a validation package

Authorized administrators can export the package as an integrity-protected archive. Before approving the archive:

  1. confirm every required controlled filename is present once;
  2. review the package version and build provenance;
  3. verify the manifest and checksums;
  4. preserve the archive in the organization’s approved document repository;
  5. record approval and any accepted limitations.

Release and change control

A validation package applies to a defined release, environment, intended use, and configuration baseline. Reassess validation after material software, infrastructure, integration, or process changes.

Customer execution

Vendor documentation can accelerate validation, but customer-specific tests, approvals, infrastructure evidence, user procedures, and intended-use decisions remain the customer’s responsibility.