Procedure for Ensuring Data Integrity in Documentation
| Department | Quality Assurance (QA)/Quality Control (QC)/Production/IT |
|---|---|
| SOP No. | SOP/Ointment/159 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for ensuring data integrity in pharmaceutical documentation. Data integrity is essential for maintaining compliance with Good Manufacturing Practices (GMP), regulatory requirements, and audit readiness.
2. Scope
This SOP applies to personnel in the Quality Assurance (QA), Quality Control (QC), Production, and IT departments responsible for maintaining, verifying, and reviewing electronic and paper-based documentation.
3. Responsibilities
- QA Officer: Ensures adherence to data integrity principles.
- QC Analyst: Verifies laboratory data for accuracy and completeness.
- Production Supervisor: Ensures real-time documentation of manufacturing processes.
- IT Department: Maintains security and audit trails for electronic records.
- QA Manager: Reviews and approves data integrity policies.
4. Accountability
The QA and IT Managers are accountable for ensuring data integrity compliance across all documentation and electronic systems.
5. Procedure
5.1 ALCOA+ Principles of Data Integrity
All data must adhere to the **ALCOA+ principles**, which ensure reliability and compliance:
- Attributable – Each entry must be linked to the person responsible.
- Legible – Data must be recorded clearly and permanently.
- Contemporaneous – Entries must be made in real-time.
- Original
– Records must be the first recording (not transcribed or copied).
Accurate – Data must be correct and free from manipulation.
Permanent – Records must be durable and not altered.
Available – Data must be accessible for review and audits.
5.2 Documentation Requirements
- Data must be recorded in **indelible ink** (for paper records) or **secure electronic systems**.
- All entries must include:
- Full name and signature of the person making the entry.
- Date and time of entry.
- Reason for any data modifications.
- Corrections must follow **Good Documentation Practices (GDP)**:
- Errors must be struck through with a single line.
- Corrections must be initialed and dated.
- Do not use correction fluid or erasers.
5.3 Ensuring Data Integrity in Electronic Records
- Electronic records must be stored in **validated systems** with controlled access.
- Systems must generate **audit trails** that track:
- User logins and modifications.
- Time-stamped changes to records.
- Reasons for data entry modifications.
- Electronic signatures must comply with **21 CFR Part 11** regulations.
- Data backups must be performed **daily** and stored in a secure location.
5.4 Reviewing and Verifying Data Integrity
- QA must conduct **monthly audits** of documentation for data integrity compliance.
- QC must verify laboratory data before final approval.
- Production records must be reviewed **before batch release**.
5.5 Handling Data Integrity Violations
- Suspected data integrity issues must be **reported to QA immediately**.
- An **investigation** must be conducted to determine:
- Root cause of the violation.
- Extent of data falsification or errors.
- Impact on product quality and regulatory compliance.
- Corrective actions may include:
- Retraining employees on data integrity policies.
- Implementing stricter access controls.
- Revalidating affected systems.
5.6 Retention and Archiving of Records
- All paper records must be archived in a **fireproof storage area**.
- Electronic records must be stored with **secure encryption**.
- Retention periods:
- Manufacturing records – **Minimum 5 years**.
- QC test records – **Minimum 7 years**.
- Audit trails – **Minimum 10 years**.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- GDP – Good Documentation Practices
- CFR – Code of Federal Regulations
- IT – Information Technology
7. Documents
- Data Integrity Compliance Checklist (Annexure-1)
- Audit Trail Review Log (Annexure-2)
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- WHO Guidelines on Data Integrity
- US FDA Guidance on Data Integrity
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Data Integrity Compliance Checklist
| Compliance Area | Verification Date | Reviewed By | Findings | Corrective Actions |
|---|---|---|---|---|
| Electronic Audit Trails | 03/02/2025 | Jane Smith | Incomplete Logs | System Update Required |
Annexure-2: Audit Trail Review Log
| Date | System Name | Audit Finding | Corrective Action | QA Approval |
|---|---|---|---|---|
| 02/02/2025 | LIMS | Unauthorized Data Change | User Access Restricted | Approved |
12. Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 02/02/2025 | 2.0 | Expanded Procedure | Improved Documentation | QA Head |