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21 CFR Part 11 support

FlaskTrack includes capabilities that can support electronic records and electronic signatures in environments where 21 CFR Part 11 is applicable. Use of the software does not automatically make a process, record, or organization compliant.

Supported control areas

FlaskTrack can support:

  • unique authenticated user accounts;
  • role-based access control;
  • password and two-factor authentication controls;
  • electronic signatures linked to specific actions and records;
  • timestamped audit records with actor and change context;
  • controlled protocol and workflow versions;
  • review and approval workflows;
  • record export and retention processes;
  • validation documentation and IQ/OQ/PQ evidence.

Organization responsibilities

The regulated organization remains responsible for:

  • determining Part 11 applicability and intended use;
  • validating the configured system for that intended use;
  • approving procedures for access, signatures, records, audit review, backup, retention, and change control;
  • training users and documenting authorization;
  • maintaining accurate system clocks and infrastructure;
  • reviewing vendor releases and changes;
  • controlling data migration, archival, and retirement;
  • evaluating integrations and external systems.

Validation Center

The Validation Center provides controlled validation documents, release evidence, integrity metadata, and export functions. Qualification workspaces provide structured IQ, OQ, and PQ execution and review.

Applicability assessment

Complete and approve a documented applicability assessment before relying on electronic records or signatures. The assessment should identify regulated records, signature meanings, retention periods, system boundaries, interfaces, risks, and compensating controls.

This documentation describes product capabilities, not legal advice or a certification of compliance. Consult qualified quality, regulatory, and legal personnel for the organization’s use case.