Standard Operating Procedure for Electronic Signature and Electronic Record

Purpose

The purpose of this SOP is to establish procedures for the use of electronic signatures and the management of electronic records within the pharmaceutical manufacturing facility. This ensures compliance with regulatory guidelines, data integrity, and traceability.

Scope

This SOP applies to all personnel involved in the manufacturing, quality control, and quality assurance of pharmaceutical products, including operators, technicians, and quality assurance personnel.

Responsibilities

• Electronic Record Owners: Responsible for ensuring the proper use and management of electronic signatures and records within their respective areas.
• Quality Assurance Personnel: Responsible for conducting periodic reviews to ensure compliance with regulatory requirements for electronic signatures and records.
• Operators and Technicians: Responsible for applying electronic signatures in accordance with established procedures and ensuring the integrity of electronic records.

Procedure

1. Definition of Electronic Signature: Clearly define what constitutes an electronic signature within the organization, including the use of unique identifiers, passwords, or other secure means of identification.
2. Authentication: Establish procedures for the authentication of individuals applying electronic signatures, ensuring that only authorized personnel have access to electronic signature credentials.
3. Authorized Electronic Signature Users: Maintain a list of authorized personnel who are allowed to apply electronic signatures. Regularly review and update this list as needed.
4. Electronic Signature Application: Define the circumstances and processes under which electronic signatures are to be applied. Ensure that the application of electronic signatures is traceable and recorded.
5. Electronic Record Management: Establish procedures for the creation, modification, and storage of electronic records. Include guidelines for naming conventions, version control, and record retention.
6. Security Controls: Implement security controls to prevent unauthorized access, modification, or deletion of electronic records. Ensure that electronic records are stored in a secure and tamper-evident manner.
7. Review of Electronic Signatures and Records: Conduct periodic reviews of electronic signatures and records to ensure compliance with regulatory requirements. Document and address any identified discrepancies or issues.
8. Audit Trail: Implement an audit trail system that captures all relevant details of electronic signature applications and record modifications. Regularly review and archive audit trail data.
9. Disabling Electronic Signatures: Define procedures for temporarily or permanently disabling electronic signatures for individuals who are no longer authorized to apply them.
10. Training: Provide training to personnel involved in the use of electronic signatures and electronic records. Ensure that they understand the importance of data integrity and compliance with regulatory requirements.
11. Documentation: Maintain detailed documentation of all electronic signatures and electronic records, including authentication logs, audit trails, and training records.
12. Periodic Review and Revision: Periodically review and revise this SOP to ensure its continued effectiveness and alignment with regulatory standards.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Electronic Signature Log
• Electronic Record Management Plan
• Authentication Records
• Training Records

Reference

21 CFR Part 11 – Electronic Records; Electronic Signatures

SOP Version

Version 1.0