– Contemporaneous: Data must be recorded at the time of observation.
– Original: Maintain original data or a verified copy.
– Accurate: Data must be correct and complete.
– Complete, Consistent, Enduring, and Available: Records must be maintained throughout the data lifecycle and accessible when required.

4.2 Data Entry Practices
– Use controlled forms, templates, or software systems for data entry.
– For paper records:
– Use indelible ink for all entries.
– Strike through errors with a single line, record the correction, and include the date and initials.
– Do not use correction fluid or erasers.
– For electronic records:
– Use validated systems that provide secure audit trails.
– Include time stamps for all data entries and modifications.
– Ensure unique login credentials for each user.

4.3 Review and Verification of Records
– Supervisors or designated personnel must review all QC records for accuracy and completeness.
– Use checklists or pre-defined criteria to ensure data aligns with the following:
– Specifications.
– Process parameters.
– Acceptance criteria.
– Verify calculations and transcriptions, and resolve discrepancies immediately.

4.4 Record Storage and Access Control
– Store paper records in designated, secure filing areas with restricted access.
– For electronic records:
– Use validated electronic data management systems with user authentication and role-based access.
– Regularly back up data to prevent loss.
– Implement encryption for sensitive data.

4.5 Data Retention and Archiving
– Retain QC records for the duration specified by regulatory guidelines or the product lifecycle, whichever is longer.
– For electronic records:
– Use formats compatible with long-term storage.
– Migrate data to updated systems or formats as needed to prevent obsolescence.
– Archive obsolete records securely, ensuring they remain accessible for audits or regulatory inspections.

4.6 Regular Audits and Inspections
– QA must perform regular audits to ensure compliance with this SOP and identify risks to data integrity.
– Include checks for:
– Unauthorized access or modifications.
– Gaps in documentation or missing records.
– Compliance with ALCOA+ principles.
– Document audit findings and implement corrective actions as needed.

4.7 Handling Data Integrity Breaches
– Report any suspected breaches of data integrity immediately to QA.
– QA must investigate the breach, document findings, and determine its impact on product quality or regulatory compliance.
– Implement corrective and preventive actions (CAPA) to address root causes and prevent recurrence.

4.8 Training and Awareness
– Conduct training sessions for all personnel involved in QC activities, focusing on:
– ALCOA+ principles.
– Proper data entry practices.
– Use of electronic data systems.
– Regulatory requirements for data integrity.
– Maintain training records, including attendance logs and evaluation results.

5) Abbreviations

– ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available
– QC: Quality Control
– QA: Quality Assurance
– CAPA: Corrective and Preventive Actions
– SOP: Standard Operating Procedure

6) Documents

– Controlled Forms and Templates
– Audit Checklists
– Training Records
– CAPA Reports
– Data Integrity Audit Reports
– Electronic Data Management System Validation Records

7) Reference

– FDA CFR Title 21, Part 11: Electronic Records; Electronic Signatures
– ISO 13485: Medical devices – Quality management systems
– ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories

8) SOP Version

– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]

Annexure

Annexure 1: Data Integrity Audit Checklist Template

Audit Date	Checklist Item	Compliance Status	Remarks
DD/MM/YYYY	Are all entries attributed to specific personnel?	Compliant	No issues found

Annexure 2: Controlled Form Template

Date	Record ID	Data Collected	Recorded By	Verified By
DD/MM/YYYY	REC-001	Measurement Results	John Doe	Jane Smith