recording and follow Good Documentation Practices (GDP).

Data Reviewers: Verify data accuracy, authenticity, and traceability before approval.

System Administrators: Manage access control, backups, and audit trails in analytical software systems.

QA Unit: Conducts periodic audits for data integrity compliance and investigates deviations.

4. Accountability

The Head of Bioanalytical Laboratory is accountable for enforcing data integrity practices and ensuring ongoing adherence to regulatory expectations across all BA/BE studies.

5. Procedure

5.1 ALCOA+ Principles Implementation

1. Ensure that all data generated meets the ALCOA+ criteria:
   • Attributable: Clearly identify who performed the action.
   • Legible: Data must be readable and permanent.
   • Contemporaneous: Record data at the time of activity.
   • Original: Maintain original source data.
   • Accurate: Ensure correctness and reliability.
   • Complete, Consistent, Enduring, Available – Additional (+) principles to support lifecycle integrity.

5.2 Data Entry and Review

1. Ensure all data entries in logbooks, software, and LIMS are dated, signed, and attributable to the person performing the activity.
2. Use ink for handwritten entries; never use pencil or correction fluid.
3. Any corrections must be made using a single line strike-through, signed, dated, and justified.
4. Electronic data shall be reviewed using audit trails, reviewer comments, and version histories.

5.3 Electronic System Controls

1. Access to analytical instruments, LIMS, and CDS shall be restricted via unique user IDs and passwords.
2. System administrators must maintain access level logs and periodically review them.
3. Audit trails shall be enabled for all critical data actions including acquisition, modification, and deletion.
4. Perform daily backup of all electronic data and store copies in secure, validated repositories.

5.4 Sample and Reagent Traceability

1. Label all reagents, samples, and solutions with:
   • Name, concentration, preparation date, expiry date, and prepared by
2. Track sample movement using Annexure-1: Sample Movement Log.

5.5 Training and Awareness

1. All personnel shall receive annual training on data integrity principles and documentation practices.
2. Training records shall be maintained as per Annexure-2: Training Record Log.

5.6 Deviation and Investigation Management

1. Any suspected data manipulation, backdating, or falsification must be immediately reported to QA.
2. QA shall investigate and document findings using Annexure-3: Data Integrity Incident Form.
3. Corrective and Preventive Actions (CAPA) must be initiated and tracked to closure.

5.7 Data Retention and Archival

1. Retain raw data, audit trails, logbooks, and reports for a minimum of 5 years or as per regulatory requirements.
2. Archived data should be stored in a manner that prevents tampering, loss, or degradation.

6. Abbreviations

• BA/BE: Bioavailability/Bioequivalence
• LIMS: Laboratory Information Management System
• CDS: Chromatography Data System
• GDP: Good Documentation Practice
• CAPA: Corrective and Preventive Action
• QA: Quality Assurance

7. Documents

1. Sample Movement Log – Annexure-1
2. Training Record Log – Annexure-2
3. Data Integrity Incident Form – Annexure-3

8. References

• MHRA GxP Data Integrity Guidance
• FDA 21 CFR Part 11
• ICH Q10: Pharmaceutical Quality System
• WHO TRS No. 996, Annex 5 – 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: Sample Movement Log

Sample ID	Date	From Location	To Location	Moved By	Verified By
PL-212	15/04/2025	Freezer -20°C	LC-MS Lab	Rajesh Kumar	Sunita Reddy

Annexure-2: Training Record Log

Employee Name	Training Topic	Date	Trainer	Remarks
Ajay Verma	Data Integrity in BA/BE	10/03/2025	QA Officer	Completed

Annexure-3: Data Integrity Incident Form

Incident ID	Date	Reported By	Description	Investigation Summary	CAPA Reference
DI-001	14/04/2025	QA Auditor	Backdated chromatogram found	Confirmed by audit trail	CAPA-009

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
17/04/2025	2.0	Expanded ALCOA+ framework and annexures added	Regulatory Update	QA Head