21 CFR and Computer System Validation

1. Key Parts of 21 CFR Relevant to CSV

21 CFR Part 11:

  • Governs electronic records and electronic signatures.
  • Ensures system integrity, security, and traceability.

Key aspects include:

  • Validation of systems to ensure accuracy, reliability, and consistency.
  • Audit trails to track changes and user actions.
  • Controls for electronic signatures equivalent to handwritten signatures.

21 CFR Part 820:

  • Applies to Quality System Regulations (QSR) for medical devices.
  • Requires validation of automated systems used in the design, manufacture, and testing of medical devices.

21 CFR Part 211:

  • Governs manufacturing practices for pharmaceuticals.
  • Includes requirements for automated systems involved in drug production, quality testing, and storage.


2. Applying 21 CFR in CSV

Planning Phase

System Requirements Definition:

  • Clearly define user and functional requirements.
  • Align these with applicable 21 CFR parts (e.g., Part 11 compliance).

Risk Assessment:

  • Identify risks associated with the computerized system and its impact on product quality and patient safety.
  • Prioritize validation activities based on risk.


Validation Activities

Validation Plan:

  • Define the scope, objectives, and responsibilities for validation.
  • Include all deliverables (e.g., IQ, OQ, PQ protocols).

Design Qualification (DQ):

  • Confirm the system design meets regulatory and business requirements.

Installation Qualification (IQ):

  • Verify proper installation of hardware and software components.

Operational Qualification (OQ):

  • Test the system’s operational functionality against specifications.

Performance Qualification (PQ):

  • Ensure the system consistently performs under real-world conditions.


Documentation and Traceability

  • Maintain comprehensive documentation of all validation activities.
  • Ensure traceability from system requirements to test cases and results.


Control Measures

Change Management:

  • Control changes to validated systems through a formal change management process.

Access Controls:

  • Limit system access to authorized personnel.

Audit Trails:

  • Ensure that the system logs all critical actions and changes.

Periodic Review

  • Regularly review and revalidate systems to ensure ongoing compliance with 21 CFR.


3. Practical Tips for 21 CFR Compliance in CSV

  • Use a risk-based approach for validation efforts.
  • Leverage tools and templates to streamline documentation.
  • Train personnel on 21 CFR requirements and CSV principles.
  • Conduct regular internal audits to identify and address compliance gaps.


Read also:


Resource Person: Siman Reddy Pondugula

Similar Posts

Leave a Reply

Your email address will not be published. Required fields are marked *