SOP Guide for Pharma

SOP for Ensuring Data Integrity in EHS Documentation

SOP for Ensuring Data Integrity in EHS Documentation

Standard Operating Procedure for Ensuring Data Integrity in Environmental, Health, and Safety (EHS) Documentation

1) Purpose

The purpose of this SOP is to establish guidelines for maintaining data integrity in Environmental, Health, and Safety (EHS) documentation, ensuring accuracy, consistency, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in creating, managing, and maintaining EHS documentation, including records related to safety audits, incident reports, training logs, waste disposal, and compliance reports.

3) Responsibilities

4) Procedure

4.1 Data Collection and Entry

  1. Use Approved Templates:
    • Ensure all data is recorded using standardized templates to maintain consistency across documents.
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  3. Verify Source Data:
    • Cross-check raw data, such as test results or incident details, against original records for accuracy before entry.
  4. Ensure Completeness:
    • Review entries to confirm that all required fields are completed and accurately reflect the source data.

4.2 Data Validation and Review

  1. Conduct Regular Reviews:
    • Schedule periodic reviews of EHS documentation to identify and correct errors or inconsistencies.
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  3. Implement Validation Checks:
    • Use automated or manual validation checks to ensure data entries align with predefined criteria, such as acceptable ranges or formats.
  4. Flag Discrepancies:
    • Highlight and investigate anomalies or discrepancies in data, and document corrective actions taken.

4.3 Data Security and Access Control

  1. Restrict Access:
    • Limit access to EHS documentation systems to authorized personnel only, based on roles and responsibilities.
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  3. Maintain Audit Trails:
    • Enable audit trails in digital systems to track changes, including timestamps, user details, and descriptions of modifications.
  4. Implement Data Encryption:
    • Use encryption methods to protect sensitive EHS data, both in transit and at rest.

4.4 Data Backup and Recovery

  1. Schedule Regular Backups:
    • Back up EHS documentation daily, using automated systems for secure storage in multiple locations.
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  3. Test Recovery Systems:
    • Conduct regular tests of backup and recovery systems to ensure data can be restored quickly and accurately if needed.
  4. Document Backup Processes:
    • Maintain records of backup schedules, storage locations, and recovery tests for audit purposes.

4.5 Continuous Improvement

  1. Gather Feedback:
    • Solicit feedback from users to identify challenges or inefficiencies in data integrity processes.
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  3. Update Procedures:
    • Revise this SOP as needed to reflect new technologies, regulations, or organizational changes.
  4. Train Employees:
    • Provide regular training sessions on data integrity principles and updates to the SOP.

5) Abbreviations, if any

6) Documents, if any

7) Reference, if any

8) SOP Version

Version: 1.0

Annexure

Template 1: EHS Data Validation Log

 
Date Document Type Validated By Discrepancies Identified Corrective Actions
DD/MM/YYYY Incident Report John Doe Incorrect Date Updated Entry

Template 2: Data Backup Log

 
Date Backup Type Storage Location Status Remarks
DD/MM/YYYY Full Cloud Server A Successful None
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