Skip Navigation Links.

Electronic Records and Signatures (21 CFR Part 11 Compliance)

21 CFR Part 11 Overview

21 CFR Part 11 is a regulation issued by the U.S. Food and Drug Administration (FDA) that sets forth the criteria for electronic records and electronic signatures in the pharmaceutical, biotechnology, and medical device industries. It establishes the requirements for the use of electronic systems to create, modify, maintain, archive, retrieve, or transmit certain records and documents subject to FDA regulations.

Electronic Record

Electronic records in regulated environments serve as digital counterparts to traditional paper records and must hold the same significance and integrity. They are subject to the same stringent regulatory standards, such as those outlined in 21 CFR Part 11. Electronic records must accurately capture, store, and represent critical information related to processes, data, and transactions. These records are essential for documenting, tracking, and verifying activities in various industries, particularly in pharmaceuticals and healthcare.

The meaning and importance of electronic records lie in their legal equivalence to paper records, their role in establishing transparency and traceability, and their ability to provide a reliable and secure means of preserving critical data. Electronic records must adhere to regulatory requirements to ensure their authenticity, accuracy, and security, ultimately contributing to compliance and maintaining trust in digital documentation and transactions.

Electronic Signature

Electronic signatures in regulated environments must carry the same legal significance and intent as handwritten signatures. This equivalence is essential for maintaining the integrity and authenticity of electronic records and transactions. Electronic signatures establish accountability, trust, and transparency by confirming that the signatory is committing to the content or action represented by the signature. To ensure that electronic signatures have meaning, organizations must adhere to robust processes and compliance regulations, such as 21 CFR Part 11 in pharmaceuticals, which require electronic signatures to be as reliable and legally binding as their handwritten counterparts. This involves implementing secure and authenticated electronic signature procedures, maintaining tamper-evident records, and providing adequate training to personnel to ensure they understand the significance of electronic signatures in regulatory compliance.

Key Provisions of 21 CFR Part 11

Key provisions of 21 CFR Part 11 outline stringent requirements for electronic recordkeeping in regulated industries. These requirements encompass validation processes to ensure system accuracy and reliability, access control measures to restrict system entry to authorized personnel, robust audit trails to securely capture all electronic record actions, legally equivalent electronic signatures linked to respective records, comprehensive system security measures, and meticulous data integrity safeguards throughout record lifecycles.

Documentation of recordkeeping procedures, staff training, and secure record retention and retrieval processes are also essential components of compliance.

21 CFR Part 11 Compliance Checklist

Using a Part 11 compliance checklist customized to an organization's specific processes and systems can significantly aid in conforming to these regulatory standards. This ensures that electronic records and systems fulfill the necessary security, integrity, and traceability criteria mandated by the regulation.

The checklist offers a systematic framework for verifying compliance with 21 CFR Part 11 requirements, and organizations should adapt and tailor it to their unique systems and processes while ensuring alignment with regulatory expectations and industry best practices.

  1. Electronic System Validation:

    • Verify that electronic systems used for regulated activities are validated.
    • Review validation documentation, including protocols, test results, and reports.
    • Ensure that validation activities demonstrate the system's accuracy, reliability, and consistent performance.
  2. Access Control and User Authentication:

    • Verify that access to electronic records and systems is controlled and restricted to authorized personnel.
    • Review access control policies, user roles, and permissions.
    • Confirm that only authorized individuals can access and modify electronic records.
  3. Audit Trail Implementation:

    • Verify the presence and effectiveness of audit trails that capture and record all actions on electronic records.
    • Review audit trail settings and test scenarios to generate and examine audit trail records.
    • Ensure that audit trails are secure, time-stamped, and tamper-evident.
  4. Electronic Signature Compliance:

    • Verify that electronic signatures are legally equivalent to handwritten signatures and properly linked to electronic records.
    • Review electronic signature processes and authentication methods.
    • Confirm that electronic signatures are secure and appropriately controlled.
  5. System Security Measures:

    • Verify that security measures are in place to prevent unauthorized access, data alteration, or deletion.
    • Review security policies, user authentication, and password policies.
    • Ensure that data and systems are protected from unauthorized access or tampering.
  6. Data Integrity Safeguards:

    • Verify that electronic records are accurate, complete, and reliable.
    • Review data integrity policies, validation results, and change control processes.
    • Confirm that data integrity is maintained throughout the record lifecycle.
  7. Documentation of Procedures:

    • Verify that all procedures, policies, and practices related to electronic recordkeeping and electronic signatures are documented.
    • Review written standard operating procedures (SOPs) and recordkeeping policies.
    • Ensure that documented procedures align with regulatory requirements.
  8. Training for Personnel:

    • Verify that personnel involved in electronic recordkeeping receive appropriate training.
    • Review training records and training programs.
    • Confirm that personnel are adequately trained on Part 11 requirements.
  9. Retention and Retrieval of Records:

    • Verify that electronic records are maintained and retrievable throughout their retention periods.
    • Review record retention policies and practices.
    • Ensure that records are stored securely and accessible for review and inspection by regulatory authorities.
  10. Handling Electronic Copies:

    • Verify procedures for handling electronic copies of paper records and electronic records created to meet regulatory requirements.
    • Review policies and practices for creating, managing, and retaining electronic copies.
    • Confirm that procedures align with regulatory expectations for electronic copies.
  11. Regular Reviews and Audits:

    • Verify that regular reviews and audits are conducted to verify compliance.
    • Review audit reports and compliance monitoring activities.
    • Ensure that reviews and audits identify and address non-compliance issues promptly.
  12. Comprehensive Documentation:

    • Verify that comprehensive documentation of Part 11 compliance efforts is maintained.
    • Review all documentation related to Part 11 compliance activities.
    • Ensure that a clear and complete documentation trail exists for Part 11 compliance efforts.

21 CFR Part 11 Remediation Actions

Part 11 remediation actions encompass a set of measures aimed at resolving non-compliance issues and aligning electronic records and signatures with the rigorous standards outlined in 21 CFR Part 11. These actions are essential for achieving regulatory compliance and ensuring the integrity and security of electronic records and signatures in regulated industries.

Typically, these actions include the review and update of policies and procedures to align them with regulatory standards, the revalidation of electronic systems to ensure accuracy and reliability, the enhancement of access controls to restrict system entry to authorized individuals, and the strengthening of audit trail capabilities to securely capture all electronic record actions.

Remediation efforts may also emphasize the implementation of secure electronic signature processes that meet legal equivalence standards, the enhancement of system security to prevent unauthorized access, and the establishment of robust data integrity measures throughout the record lifecycle.

Additionally, key components of Part 11 remediation efforts encompass regular personnel training, systematic record retention and retrieval processes, and internal audits to identify and rectify compliance gaps.