SOP Guide for Pharma

SOP for Ensuring Data Integrity in EHS Documentation

Auditor

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

  • EHS Documentation Officer: Oversee data management practices and ensure compliance with data integrity standards.
  • Department Heads: Review and verify documentation within their departments for accuracy and completeness.
  • IT Support Team: Manage digital data security and ensure proper backup systems are in place.
  • Employees: Follow prescribed procedures to ensure data accuracy and integrity when entering or updating records.
See also  SOP for Activation and Use of Fire Suppression Systems

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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  2. Verify Source Data:
    • Cross-check raw data, such as test results or incident details, against original records for accuracy before entry.
  3. 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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  • Implement Validation Checks:
    • Use automated or manual validation checks to ensure data entries align with predefined criteria, such as acceptable ranges or formats.
  • 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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    2. Maintain Audit Trails:
      • Enable audit trails in digital systems to track changes, including timestamps, user details, and descriptions of modifications.
    3. 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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    2. Test Recovery Systems:
      • Conduct regular tests of backup and recovery systems to ensure data can be restored quickly and accurately if needed.
    3. 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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    2. Update Procedures:
      • Revise this SOP as needed to reflect new technologies, regulations, or organizational changes.
    3. Train Employees:
      • Provide regular training sessions on data integrity principles and updates to the SOP.

    5) Abbreviations, if any

    • EHS: Environmental, Health, and Safety
    • IT: Information Technology

    6) Documents, if any

    • EHS Data Validation Logs
    • Audit Trail Reports
    • Data Backup and Recovery Logs

    7) Reference, if any

    • ISO 9001 Quality Management Standards
    • ISO 27001 Information Security Management Standards
    • OSHA Recordkeeping Guidelines

    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
    See also  SOP for Documenting and Reporting Near-Miss Incidents
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