Standard Operating Procedure for Electronic Records and Signatures
1) Purpose
This SOP outlines the procedures for managing electronic records and signatures in pharmaceutical manufacturing to ensure compliance with regulatory requirements for data integrity, authenticity, and traceability.
2) Scope
This SOP applies to all electronic records and signatures generated, reviewed, approved, or maintained within the pharmaceutical facility, including computerized systems and electronic documentation.
3) Responsibilities
The Quality Assurance (QA) department is responsible for overseeing compliance with electronic records and signatures procedures. All personnel involved in electronic record management are responsible for adhering to this SOP.
4) Procedure
4.1 General Principles
- Ensure electronic records are created, maintained, and retained in a secure and controlled environment to prevent unauthorized access, alteration, or deletion.
- Apply appropriate controls to electronic signatures to ensure they are legally binding and equivalent to handwritten signatures.
4.2 Documentation Requirements
- Define procedures for documenting electronic record creation, modification, and review activities.
- Maintain detailed documentation of electronic signature use, including identity verification and authorization procedures.
4.3 Access Control
- Implement access controls based on user roles and responsibilities to restrict access to electronic records and signatures.
- Ensure only authorized personnel have access to electronic systems and records as per documented procedures.
4.4 Audit Trails and System Security
- Enable and maintain audit trails in electronic systems to record all changes, deletions, or additions to electronic records.
- Implement robust system security measures to protect electronic records from unauthorized access, tampering, or loss.
4.5 Validation and Compliance
- Validate electronic systems used for record management to ensure they meet regulatory requirements for data integrity, security, and reliability.
- Regularly assess and document compliance with electronic records and signatures regulations through audits and inspections.
4.6 Training and Awareness
- Provide training on electronic records and signatures procedures to all personnel involved in electronic record management.
- Ensure ongoing awareness of regulatory updates and best practices related to electronic records and signatures.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
Electronic Records and Signatures Policy, Electronic System Validation Documentation, Training Records
7) Reference, if any
Regulatory guidelines such as FDA 21 CFR Part 11 Electronic Records; Electronic Signatures, EU GMP Annex 11 Computerized Systems, PIC/S PI 011-3 Good Practices for Computerized Systems in Regulated “GXP” Environments
8) SOP Version
Version 1.0
