SOP for Ensuring Data Integrity During Analytical Method Development Activities

Department	Analytical Method Development
SOP No.	SOP/AMD/037/2025
Supersedes	SOP/AMD/037/2022
Page No.	Page 1 of 14
Issue Date	19/05/2025
Effective Date	20/05/2025
Review Date	19/05/2026

1. Purpose

This SOP outlines the principles and procedures required to ensure data integrity during analytical method development activities. It ensures that all data—whether electronic or paper-based—are accurate, complete, consistent, and secure throughout their lifecycle.

2. Scope

This SOP applies to all data generated during method development, including raw data, chromatograms, spectra, calculations, reports, electronic audit trails, and records associated with analytical instrumentation and software within the AMD department.

3. Responsibilities

• Analytical Scientists: Generate, record, and review data in accordance with ALCOA+ principles and GMP requirements.
• QA: Conducts periodic data integrity audits and reviews audit trails and logbooks.
• IT: Ensures access controls, backup, and system security for computerized systems.
• Head – AMD: Ensures enforcement of data integrity procedures and takes corrective actions for any breach.

4. Accountability

The Head of AMD is accountable for ensuring continuous enforcement of data integrity practices across all AMD activities and reporting any suspected data falsification or non-compliance to senior management.

5. Procedure

5.1 Data Integrity Principles (ALCOA+)

1. Ensure that all data meet the following criteria:
   • Attributable: Data must clearly identify the person generating it.
   • Legible: Records must be readable and permanent.
   • Contemporaneous: Recorded at the time of activity.
   • Original: First recorded observation or certified true copy.
   • Accurate: Free from errors, edited with justification if needed.
   • Complete, Consistent, Enduring, Available: ALCOA+ attributes

5.2 Electronic Data Handling

1. Use validated software systems with 21 CFR Part 11 compliance (e.g., Empower, LabSolutions).
2. Enable secure login with role-based access control.
3. Ensure electronic records are backed up on secure servers as per SOP/IT/005/2025.
4. Enable and retain audit trails without overwrite capability.
5. Printouts or exported data must be linked to original raw data for traceability.

5.3 Paper-Based Record Management

1. Entries must be made using indelible ink and signed with date/time.
2. No overwriting or backdating is permitted. Corrections must include:
   • Strike-through single line
   • Initials, date, and reason for change
3. All paper records must be stored in secure, access-controlled storage areas.

5.4 Data Review and Approval

1. All data must be reviewed by a second analyst or reviewer before final reporting.
2. Review includes:
   • Chromatograms/spectra match calculations
   • Audit trails reviewed and signed
   • Any data exclusion is justified and approved by QA
3. Document review status in Annexure-1: Data Integrity Review Checklist.

5.5 Audit Trail Monitoring

1. Audit trails of key systems (HPLC, GC, UV) shall be reviewed weekly or per method lifecycle.
2. Events monitored include:
   • Deletion of data files
   • Changes to integration parameters
   • Modifications to user access
3. Record observations in Annexure-2: Audit Trail Review Log.

5.6 Data Integrity Breach Handling

1. Suspected data manipulation or falsification must be reported immediately to QA and Head – AMD.
2. QA initiates deviation report and conducts root cause analysis.
3. Corrective actions may include:
   • User retraining
   • Revocation of access
   • Revision of SOPs
4. All incidents to be tracked using Annexure-3: Data Integrity Incident Register.

5.7 Training and Awareness

1. All analysts and reviewers must undergo annual data integrity training.
2. Training topics include ALCOA+, audit trail use, record keeping, and data falsification consequences.
3. Document participation in Annexure-4: Data Integrity Training Log.

6. Abbreviations

• AMD: Analytical Method Development
• QA: Quality Assurance
• ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available
• SOP: Standard Operating Procedure

7. Documents

1. Data Integrity Review Checklist – Annexure-1
2. Audit Trail Review Log – Annexure-2
3. Data Integrity Incident Register – Annexure-3
4. Data Integrity Training Log – Annexure-4

8. References

• FDA Guidance on Data Integrity and Compliance with CGMP
• MHRA GxP Data Integrity Guidance
• WHO TRS 1019 Annex 5 – Good Data and Record Management Practices
• 21 CFR Part 11 – Electronic Records; Electronic Signatures

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 Review Checklist

Parameter	Status	Reviewed By	Date
Data Attributability Verified	Yes	Rajesh Kumar	05/05/2025
Electronic Audit Trail Reviewed	Yes	Sunita Reddy	06/05/2025

Annexure-2: Audit Trail Review Log

Date	System	Activity	Reviewer	Observations
07/05/2025	HPLC-03	Audit Trail Event Log	Ajay Verma	No abnormal entries

Annexure-3: Data Integrity Incident Register

Incident ID	Date	Description	Action Taken	Status
DI/2025/004	10/05/2025	Chromatogram deleted	User suspended & retrained	Closed

Annexure-4: Data Integrity Training Log

Employee Name	Department	Training Date	Trainer	Status
Meenal Patil	AMD	01/05/2025	QA Manager	Completed

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
04/05/2025	2.0	Added annexures for audit trail and training logs	GMP Data Review Audit