Key points
- Pharmacovigilance documents must be archived, retained, accessed, and retired through controlled processes that preserve inspection evidence and prevent use of obsolete documents.
- Retention periods must be defined and aligned with regulatory, quality system, and company requirements.
- Access to controlled documents must be restricted so that users can only rely on current approved versions.
- Obsolete and retired documents must be clearly identified, removed from active use, and retained where required.
- Archived records must remain secure, retrievable, complete, and inspection-ready.
- Inspection-ready evidence must demonstrate controlled retention, access permissions, obsolete copy management, and document retrieval capability.
What inspectors expect
Each point below should be supported by controlled documents and traceable records.
- PV documents and records must be retained according to defined requirements.
- Archived documents must remain complete, secure, and retrievable.
- Only current approved documents must be available for routine use.
- Obsolete documents must be removed from active circulation.
- Access rights and audit trails must support document integrity and compliance.
Summary
Inspectors assess whether pharmacovigilance documents are archived, retained, accessed, and retired through controlled processes. They review retention rules, access permissions, obsolete document controls, and evidence that archived records are complete and retrievable. They also assess whether document control prevents use of outdated or uncontrolled documents across the PV system.
Common questions
These are the questions this page is designed to answer directly.
- How are pharmacovigilance documents archived?
- What do inspectors check for document archiving in PV?
- How long should pharmacovigilance documents be retained?
- What is document retirement in pharmacovigilance?
- How do you control access to PV documents?
- How do you prevent use of obsolete documents?
- What are retention requirements for PV records?
- What is access control in document management?
- How do regulators assess document archiving and retention?
- What evidence is required for document control compliance?
Evidence objects inspectors expect
Document Archiving and Retention Records
- Defined retention periods for PV documents and records
- Archive records showing document storage location
- Evidence of secure and controlled record retention
- Retrieval logs or archive access records
Controlled Document Master List
- Status of active, obsolete, retired, or archived documents
- Current version number and effective date
- Document owner and responsible function
- Archive or retirement status clearly recorded
Obsolete and Retired Document Controls
- Obsolete documents clearly marked as superseded or retired
- Removal of outdated documents from active use
- Controlled retention of historical versions
- Evidence that users cannot access obsolete documents for routine work
Access Control and Permissions Evidence
- User permissions for document management systems
- Restricted editing and approval rights
- Access limited to current approved documents
- Periodic review of access rights
Electronic Records and Audit Trail Evidence
- Audit trails for document access, approval, and changes
- Electronic signatures where used
- System records showing document lifecycle events
- Traceability of who accessed or modified controlled documents
Inspection Retrieval Evidence
- Ability to retrieve historical document versions during inspection
- Evidence of archived SOPs used during specific periods
- Traceability between effective dates and operational use
- Rapid retrieval of requested PV records
Regulatory Basis (Primary Sources)
- GVP Module I – requirement for controlled documentation and quality system records
- GVP Module II – requirement for pharmacovigilance system documentation and PSMF evidence
- ICH E2D – requirement for reliable and traceable safety data management processes
- MHRA GPvP guidance – expectations for controlled, retrievable pharmacovigilance records
- FDA 21 CFR Part 11 – requirements for electronic records, audit trails, and access control
Typical Inspection Questions (What Inspectors Ask)
- How are pharmacovigilance documents archived and retained?
- How do you prevent obsolete documents from being used?
- Show me the version of this SOP that was effective at the time of this case.
- Who has access to edit or approve controlled documents?
- How quickly can you retrieve archived PV records during inspection?
Failure patterns
Obsolete SOPs remain accessible and are used in active operations.
Archived documents cannot be retrieved during inspection.
Retention periods are undefined or inconsistently applied.
Access rights allow unauthorised editing or uncontrolled document changes.
Historical versions are missing, incomplete, or not linked to effective dates.
What good looks like
- Defined archive and retention rules for all PV documents and records.
- Clear separation between active, obsolete, retired, and archived documents.
- Controlled access ensuring users rely only on approved current documents.
- Complete historical document versions retained and retrievable.
- Audit trails supporting access, approval, change, and retirement events.
Operationalisation
- Define document retention and archive requirements in the PV document control SOP.
- Maintain a controlled master list showing active, obsolete, retired, and archived document status.
- Restrict user access so only current approved documents are available for routine use.
- Mark obsolete documents clearly and remove them from operational circulation.
- Ensure archived documents remain secure, complete, and retrievable during inspections.
- Review access permissions and archive controls periodically to confirm continued compliance.
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FAQ
What is document archiving in pharmacovigilance?
Document archiving is the controlled storage of historical PV documents and records so they remain secure, complete, retrievable, and available as inspection evidence.
How long should pharmacovigilance documents be retained?
Retention periods should be defined in company procedures and aligned with applicable regulatory, quality system, and business requirements for PV records.
What is document retirement in pharmacovigilance?
Document retirement is the formal removal of a controlled document from active use while retaining it as a historical record where required.
How do you prevent use of obsolete PV documents?
Obsolete documents are controlled by removing them from active locations, restricting access, marking them as superseded or retired, and ensuring only current approved versions are available to users.
Do inspectors review archived pharmacovigilance documents?
Yes. Inspectors may request historical SOP versions, approval records, revision histories, and archive evidence to verify what procedures were in effect at a specific time.
What access controls are expected for PV documents?
Access controls should restrict editing, approval, and distribution rights to authorised personnel and ensure users can access only current approved documents for routine activities.
What is an uncontrolled copy in document control?
An uncontrolled copy is a document copy that is not managed within the official document control system and may become outdated or inconsistent with the approved version.
Sources
Primary guidance used to inform this map. This page is a structured interpretation layer; always validate against the original source documents.
European Medicines Agency (EMA)
- Guideline on good pharmacovigilance practices (GVP) – Module IView source
- Guideline on good pharmacovigilance practices (GVP) – Module IIView source
FDA
- 21 CFR Part 11 – Electronic RecordsView source
ICH
- Post-Approval Safety Data Management (E2D)View source
MHRA
- Good Pharmacovigilance Practice (GPvP)View source