Designed with 21 CFR Part 11 Compliance

The REMETREX PQMS approach to electronic records, electronic signatures, audit trails, access controls, and regulated complaint management.

Designed around the requirements of regulated electronic records.

REMETREX PQMS is positioned in the strategic materials as a 21 CFR Part 11 compliant application, with electronic records, audit trails, and access controls treated as foundational elements.

21 CFR Part 11 Complaint Management Software

  • Designed for Regulated Use

    The system was designed around the needs of regulated quality teams, with controls intended to support electronic records and controlled complaint-management processes.

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  • Electronic Records

    Complaint records are maintained within a structured application rather than relying solely on disconnected documents or spreadsheets.

  • Audit Trail

    The strategic materials describe an immutable audit trail across records and actions. The final technical specification should define exactly what events are captured, retained, and reviewable.

  • Access Controls

    Controlled access is a foundational component of a regulated application. Customer procedures should define roles, permissions, provisioning, review, and deprovisioning.

  • Electronic Signatures

    Where electronic signatures are used, the implementation should be evaluated and controlled according to applicable Part 11 requirements and the organization’s procedures.

  • Customer Responsibility

    Software designed to support Part 11 does not by itself make an organization compliant. The customer remains responsible for appropriate procedures, validation, training, configuration, security, and use.

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