Standard Operating Procedure for Ensuring Data Integrity in Electronic Storage Logs
| Department | Warehouse / Quality Assurance / IT |
|---|---|
| SOP No. | SOP/RM/182/2025 |
| Supersedes | SOP/RM/182/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 17/04/2025 |
| Effective Date | 24/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
This Standard Operating Procedure (SOP) establishes guidelines for ensuring the integrity, accuracy, and security of electronic storage logs used to manage raw materials. This SOP complies with Good Manufacturing Practices (GMP) and 21 CFR Part 11 for electronic records.
2. Scope
This SOP applies to all warehouse, quality assurance (QA), and IT personnel involved in managing, reviewing, and securing electronic storage logs for raw materials.
3. Responsibilities
- Warehouse Personnel: Ensure accurate entry and timely updates of storage data in electronic logs.
- Quality Assurance (QA) Team: Review and verify data integrity, ensuring compliance with regulatory standards.
- IT Department: Maintain the electronic systems, ensure data security, and provide backup and recovery protocols.
4. Accountability
The QA Manager is accountable for data review and integrity checks, while the IT Manager is responsible for system security, data backup, and recovery. The Warehouse Manager ensures accurate data entry and compliance with the SOP.
5. Procedure
5.1 Data Entry and Verification
- Electronic Data Entry:
- All storage data must be entered electronically using validated systems compliant with 21 CFR Part 11.
- Document entries in the Electronic Storage Log Entry Log (Annexure-1).
- Verification of Data Entries:
- QA personnel must verify data accuracy daily against physical records where applicable.
- Record verifications in the Data Verification Log (Annexure-2).
5.2 Data Integrity and Security
- Access Control:
- Limit system access to authorized personnel only, using unique user IDs and strong passwords.
- Record user access permissions in the Access Control Log (Annexure-3).
- Audit Trails:
- Ensure audit trails are enabled for all electronic logs, capturing changes, deletions, and timestamps.
- Document audit trail reviews in the Audit Trail Review Log (Annexure-4).
5.3 Backup and Data Recovery
- Regular Backups:
- IT must perform daily automated backups of electronic storage logs.
- Record backup activities in the Backup Log (Annexure-5).
- Data Recovery Testing:
- Conduct quarterly tests of backup recovery processes to ensure data integrity in the event of data loss.
- Document tests in the Data Recovery Test Log (Annexure-6).
5.4 Handling Data Discrepancies and Breaches
- Identifying Discrepancies:
- Any discrepancies between electronic and physical logs must be reported immediately.
- Document discrepancies in the Data Discrepancy Log (Annexure-7).
- Data Breach Response:
- In case of suspected data breaches, IT must investigate and take corrective actions immediately.
- Record breach incidents and resolutions in the Data Breach Incident Log (Annexure-8).
5.5 Training and Continuous Improvement
- Training on Data Integrity:
- Conduct regular training sessions on data integrity protocols and electronic log management.
- Document training sessions in the Data Integrity Training Log (Annexure-9).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- IT: Information Technology
7. Documents
- Electronic Storage Log Entry Log (Annexure-1)
- Data Verification Log (Annexure-2)
- Access Control Log (Annexure-3)
- Audit Trail Review Log (Annexure-4)
- Backup Log (Annexure-5)
- Data Recovery Test Log (Annexure-6)
- Data Discrepancy Log (Annexure-7)
- Data Breach Incident Log (Annexure-8)
- Data Integrity Training Log (Annexure-9)
8. References
- 21 CFR Part 11 – Electronic Records; Electronic Signatures
- WHO Good Storage Practices for Pharmaceuticals
- FDA Guidance on Data Integrity and Compliance with CGMP
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
Annexure-1: Electronic Storage Log Entry Log
| Date | Material Name | Entry Description | Entered By |
|---|---|---|---|
| 17/04/2025 | API X | Batch logged in ERP | Ravi Kumar |
Annexure-2: Data Verification Log
| Date | Material Name | Verification Status | Verified By |
|---|---|---|---|
| 17/04/2025 | API X | Verified | Neha Verma |
Annexure-3: Access Control Log
| Date | User Name | Access Level | Granted By |
|---|---|---|---|
| 17/04/2025 | Amit Joshi | Read/Write | IT Admin |
Annexure-4: Audit Trail Review Log
| Date | Log Reviewed | Findings | Reviewed By |
|---|---|---|---|
| 17/04/2025 | Electronic Storage Log | No discrepancies found | QA Manager |
Annexure-5: Backup Log
| Date | System Backed Up | Backup Status | Performed By |
|---|---|---|---|
| 17/04/2025 | ERP System | Successful | Ajay Sharma |
Annexure-6: Data Recovery Test Log
| Date | System Tested | Recovery Status | Tested By |
|---|---|---|---|
| 17/04/2025 | ERP System | Successful | IT Supervisor |
Annexure-7: Data Discrepancy Log
| Date | Material Name | Discrepancy Description | Reported By |
|---|---|---|---|
| 17/04/2025 | API Y | Incorrect batch number logged | Kiran Patel |
Annexure-8: Data Breach Incident Log
| Date | Breach Description | Action Taken | Resolved By |
|---|---|---|---|
| 17/04/2025 | Unauthorized access attempt detected | Account locked, password reset | IT Admin |
Annexure-9: Data Integrity Training Log
| Date | Employee Name | Training Topic | Trainer | Remarks |
|---|---|---|---|---|
| 17/04/2025 | Sanjay Mehta | Data Integrity and Compliance | QA Manager | Completed Successfully |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Implementation | QA Head |
| 17/04/2025 | 2.0 | Updated procedures for electronic data security and compliance. | Regulatory Update | QA Head |