in the API manufacturing site.

3. Responsibilities

• QC Analyst: Enter test data into LIMS accurately and ensure proper documentation.
• QC Reviewer: Review and verify each LIMS entry for correctness and traceability.
• QA Officer: Perform periodic audits of LIMS data and ensure system compliance with 21 CFR Part 11.

4. Accountability

The Head – Quality Control is accountable for overall integrity, compliance, and verification of LIMS data entries in accordance with regulatory and internal policies.

5. Procedure

5.1 General Requirements

1. Only trained and authorized personnel must access the LIMS.
2. User roles and access privileges shall be defined and documented by QA/IT.
3. Electronic signatures and audit trails must be enabled and compliant with 21 CFR Part 11.

5.2 Data Entry by Analyst

1. Log in to LIMS with personal user credentials.
2. Select appropriate template or worksheet assigned to the product or test.
3. Enter raw data such as:
   • Sample ID
   • Batch number
   • Date and time of analysis
   • Instrument ID
   • Test results (numeric values, observations, pass/fail)
4. Attach scanned raw data files, chromatograms, or instrument printouts where applicable.
5. Save the entry and digitally sign the data to complete submission.

5.3 Review and Verification by Reviewer

1. Log in with reviewer access and navigate to “Pending Verification” queue.
2. Cross-check entries with:
   • Analytical worksheet
   • Instrument logbook
   • Raw data attachments
3. Verify calculations, units, specifications, and compliance with STP.
4. If discrepancies are found, reject the entry and notify the analyst for correction through documented workflow.
5. Upon successful verification, approve the data and complete reviewer sign-off.

5.4 Audit Trail Review

1. QA or designated personnel must review audit trails:
   • During batch release review
   • For any modified, deleted, or corrected entries
   • During internal audits or regulatory inspections
2. Document the audit trail review in the LIMS Audit Review Log (Annexure-1).

5.5 Data Integrity and Security

1. Do not share user IDs or passwords under any circumstance.
2. Enable automatic log-off after inactivity (e.g., 10 minutes).
3. All records must remain unaltered once approved unless accompanied by a justified change request.
4. Backup of the LIMS database must be performed daily as per IT SOP.

5.6 Error Handling

1. If a data entry error is identified:
   • Initiate a LIMS correction request
   • Document justification and supporting evidence
   • Obtain QA approval before making any changes
2. All modifications must retain the original value (strike-through or audit trail visibility).

5.7 Training and Periodic Review

1. All analysts and reviewers shall undergo training on:
   • LIMS operation
   • Data integrity
   • Change control and audit trail policies
2. QA shall perform periodic review of LIMS operations and generate audit summaries (Annexure-2).

6. Abbreviations

• LIMS: Laboratory Information Management System
• QC: Quality Control
• QA: Quality Assurance
• STP: Standard Test Procedure
• SOP: Standard Operating Procedure

7. Documents

1. LIMS Data Entry Verification Checklist
2. LIMS Audit Trail Review Log (Annexure-1)
3. LIMS Periodic Review Summary (Annexure-2)

8. References

• 21 CFR Part 11 – Electronic Records; Electronic Signatures
• MHRA Guidance on Data Integrity
• ICH Q9 – Quality Risk Management

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: LIMS Audit Trail Review Log

Date	Reviewed By	Record Type	Observation	Action Taken
13/04/2025	QA Officer	API Batch Release	No unauthorized edits	Filed

Annexure-2: LIMS Periodic Review Summary

Review Period	Reviewed By	No. of Entries Reviewed	Issues Found	Remarks
Q1 2025	QA Team	134	2 Minor Deviations	Corrective Actions Implemented

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	Implementation of LIMS	QA Head
13/04/2025	2.0	Added audit trail log and error handling workflow	Audit Recommendation	QA Head