SOP Guide for Pharma

SOP for Ensuring Data Integrity in Electronic Storage Logs – V 2.0

Auditor

SOP for Ensuring Data Integrity in Electronic Storage Logs – V 2.0

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

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

See also  SOP for Storage of Raw Materials in Holding Area Before Quarantine - V 2.0

5.1 Data Entry and Verification

  1. 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).
  2. 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

  1. 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).
  2. 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

  1. Regular Backups:
    • IT must perform daily automated backups of electronic storage logs.
    • Record backup activities in the Backup Log (Annexure-5).
  2. 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

  1. Identifying Discrepancies:
    • Any discrepancies between electronic and physical logs must be reported immediately.
    • Document discrepancies in the Data Discrepancy Log (Annexure-7).
  2. 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).
See also  SOP for Receiving Organic Solvents and Other Volatile Raw Materials - V 2.0

5.5 Training and Continuous Improvement

  1. 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

7. Documents

  1. Electronic Storage Log Entry Log (Annexure-1)
  2. Data Verification Log (Annexure-2)
  3. Access Control Log (Annexure-3)
  4. Audit Trail Review Log (Annexure-4)
  5. Backup Log (Annexure-5)
  6. Data Recovery Test Log (Annexure-6)
  7. Data Discrepancy Log (Annexure-7)
  8. Data Breach Incident Log (Annexure-8)
  9. Data Integrity Training Log (Annexure-9)

8. References

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
See also  SOP for Receiving Hazardous Chemicals and High-Risk Raw Materials - V 2.0

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
Exit mobile version