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Compliance overview

FlaskTrack provides configurable controls for traceability, reviews, evidence, authorization, signatures, and validation activities. These features support an organization’s quality system; they do not replace procedures, training, risk assessment, validation, or legal interpretation.

Compliance overview in FlaskTrack
The compliance area brings frameworks, checklists, events, validation, and evidence controls together.

Control areas

flowchart TB
    A[Frameworks and policies] --> B[Authorization and checklists]
    B --> C[Operational execution]
    C --> D[Audit trail and evidence]
    D --> E[Electronic signatures and reviews]
    E --> F[Validation and qualification]

Frameworks and policies

Frameworks represent an external requirement or internal policy. Regulatory tags, levels, scopes, and authorization rules determine where a policy applies and whether an action is allowed, requires approval, or is blocked.

Checklists and evidence

Checklists capture objective confirmations and required evidence. Scope rules determine which entities and actions receive a checklist.

Audit trail

Auditable actions record the actor, action, entity, time, and available before/after context. Integrity chaining helps detect alteration.

Electronic signatures

Selected high-risk actions require reauthorization and create an electronic-signature record tied to the action and entity.

Compliance events

Events record deviations, incidents, exceptions, investigations, and follow-up work according to organization procedure.

Validation and qualification

The Validation Center stores controlled documentation and exportable release evidence. Qualification workspaces support IQ, OQ, and PQ test execution and review.

  1. Define intended use and applicable requirements.
  2. Configure roles and approval responsibilities.
  3. Create frameworks, levels, tags, rules, and scopes.
  4. Create focused checklists and reference documents.
  5. Configure electronic-signature expectations.
  6. Test representative allowed, approval-required, and blocked actions.
  7. Execute validation and qualification activities.
  8. Approve the production configuration and review it periodically.

See compliance management, electronic signatures, Part 11 support, and validation.