PIC/S Guide to Good Manufacturing Practice for Medicinal Products
Documentation

PIC/S Guide to Good Manufacturing Practice for Medicinal Products PICSGMP-4: Chapter 4: Documentation - System, Record-Keeping, Data Integrity

Per PIC/S GMP Chapter 4: documentation. Requirements include (a) implement Documentation System including controlled procedures + work instructions + specifications + records + reports + (b) implement Record Keeping including batch records + raw materials + in-process tests + finished product testing + cleaning + maintenance + training + complaints + investigations + (c) ensure data integrity including ALCOA+ principles - Attributable + Legible + Contemporaneous + Original + Accurate + Complete + Consistent + Enduring + Available + (d) implement document control including version + approval + distribution + retention + retirement + (e) implement electronic record + signature controls per 21 CFR Part 11 + Annex 11 where applicable + (f) maintain retention aligned to regulatory + investigative requirements.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

What else in your programme already covers this

This control maps to 48 controls across 24 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

21 CFR Part 211 - Current Good Manufacturing Practice · 3 controls

BSI IT-Grundschutz · 3 controls

  • BSI-28 Audit event logging and storage
  • BSI-29 Audit record review and analysis
  • BSI-31 Audit log protection and retention

NIST SP 800-53 Rev 5 · 3 controls

SWIFT CSCF · 3 controls

  • SWIFTCSCF-3 Physically Secure the Environment (Objective 3)
  • SWIFTCSCF-4 Prevent Compromise of Credentials (Objective 4)
  • SWIFTCSCF-7 Plan Incident Response (Objective 7)

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence · 2 controls

  • ISO-15189-6.3 Facilities and environmental conditions
  • ISO-15189-6.5 Equipment calibration and metrological traceability

PCI DSS 4.0 · 2 controls

  • 2.1.1 2.1.1 Requirement 2 policies and procedures governed
  • 2.1.2 2.1.2 Requirement 2 roles and responsibilities assigned

21 CFR Part 58 - Good Laboratory Practice (GLP) · 1 control

  • 58.49 Laboratory Operation Areas

AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) · 1 control

  • AWWA-4.4 Audit Logging and Monitoring

Annex 11 to EU GMP - Computerised Systems · 1 control

FFIEC Cybersecurity Assessment Tool (CAT) · 1 control

  • CAT-D3-2 Detective controls

FTC GLBA Safeguards Rule (16 CFR Part 314) · 1 control

  • FTC-Safeguards-9-Elements 9 Safeguard Elements - Access, Inventory, Encryption, Secure-Dev, MFA, Disposal, Change-Mgmt, Monitoring, Pen-Test (16 CFR 314.4(c))

IEC 62304:2015 Medical Device Software Lifecycle Processes · 1 control

  • IEC62304-5.1 Software Development Planning

IEC 62351 - Power Systems Communication Security · 1 control

  • 62351-14 Cyber security event logging

ISO 27799:2025 · 1 control

  • ISO27799-05 Audit trail for ePHI access

ISO/IEC 17025:2017 - General Requirements for Testing and Calibration · 1 control

  • ISO-17025-6.5 Metrological traceability

ISO/IEC 25012:2008 - Data Quality Model · 1 control

  • ISO-25012-4.11 Traceability

ISO/IEC 27011:2024 · 1 control

  • 27011-8.4 Logging and monitoring

ISO/IEC 27043:2015 · 1 control

  • ISO27043-24 Logging and monitoring

ISO/SAE 21434 · 1 control

  • ISO21434-24 Logging and monitoring

NIST SP 800-190 · 1 control

OWASP SAMM · 1 control

  • OWASPSAMM-5 Operations: Incident Management, Environment Management, Operational Management

SQF Code Edition 9 - Safe Quality Food · 1 control

  • 2.1.3 Food Safety and Quality Culture

Singapore AI Governance Framework · 1 control

  • AIGF-3.3 Repeatability and Traceability

South Korea ISMS-P · 1 control

  • ISMSP-SYS-03 Security Monitoring and Log Management

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Query this from an agent

The graph holds this control, the 48 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpointAll PIC/S Guide to Good Manufacturing Practice for Medicinal Products controls