PSMF Inspection Readiness Checklist

Table of Contents

• Introduction
• The Core Inspection Question
• Does the organisation understand its pharmacovigilance system?
• Does the organisation control its pharmacovigilance system?
• Can it demonstrate that control?
• Section 1: Governance Readiness
• Ownership
• Explanation
• Concrete examples
• Inspection relevance
• Sample evidence templates
• Governance Reviews
• Explanation
• Concrete examples
• Inspection relevance
• Sample evidence templates
• Section 2: QPPV Readiness
• QPPV Information
• Explanation
• Concrete examples
• Inspection relevance
• Sample evidence templates
• QPPV Awareness
• Explanation
• Concrete examples
• Inspection relevance
• Sample evidence templates
• Section 3: Product Inventory Readiness
• Product Scope
• Explanation
• Concrete examples
• Inspection relevance
• Sample evidence templates
• Reconciliation
• Explanation
• Concrete examples
• Inspection relevance
• Sample evidence templates
• Section 4: Vendor Readiness
• Vendor Inventory
• Explanation
• Concrete examples
• Inspection relevance
• Sample evidence templates
• Oversight Evidence
• Explanation
• Concrete examples
• Inspection relevance
• Sample evidence templates
• Section 5: Organisational Structure Readiness
• Explanation
• Concrete examples
• Inspection relevance
• Sample evidence templates
• Section 6: System Inventory Readiness
• Explanation
• Concrete examples
• Inspection relevance
• Sample evidence templates
• Section 7: Annex Readiness
• Annex Completeness
• Explanation
• Concrete examples
• Inspection relevance
• Sample evidence templates
• Annex Accuracy
• Explanation
• Concrete examples
• Inspection relevance
• Sample evidence templates
• Section 8: Change Control Readiness
• Explanation
• Concrete examples
• Inspection relevance
• Sample evidence templates
• Section 9: Audit and CAPA Readiness
• Audit Programme
• Explanation
• Concrete examples
• Inspection relevance
• Sample evidence templates
• CAPAs
• Explanation
• Concrete examples
• Inspection relevance
• Sample evidence templates
• Section 10: Inspection Readiness Assessment
  • Accuracy
• Explanation and evidence
• Template
  • Completeness
• Explanation and evidence
• Template
  • Traceability
• Explanation and evidence
• Template
  • Governance
• Explanation and evidence
• Template
  • Sustainability
• Explanation and evidence
• Template
• Inspection relevance
• A Simple Readiness Scoring Model
• Governance around scoring
• Practical implementation
• Inspection relevance
• What Mature Organisations Do Differently
• Expanded explanation
• Inspection relevance
• Key Takeaways
• Final note on evidence management
• References
• References
• Regulatory Note

Introduction

Many organisations prepare their PSMF shortly before an inspection.

Mature organisations maintain their PSMF in an inspection-ready state continuously.

This distinction is important.

Inspection readiness is not a document condition.

It is a governance condition.

A PSMF can appear complete while containing significant weaknesses.

Conversely, a concise PSMF may demonstrate excellent control of the pharmacovigilance system.

The objective of this checklist is therefore not simply to assess document quality.

The objective is to assess whether the PSMF accurately represents a well-governed pharmacovigilance system.

Regulatory context: European requirements (Regulation (EC) No 726/2004, Directive 2001/83/EC, Commission Implementing Regulation (EU) No 520/2012 and EMA GVP Module II) expect the PSMF to be maintained, accurate and readily available for inspection. Inspections evaluate both the content of the PSMF and the system it describes — how PV activities are governed, executed and assured.

Best practice: Develop an inspection-ready posture by embedding PSMF maintenance into routine governance activities (change control, vendor oversight, audits, management reviews), not as an episodic task.

The Core Inspection Question

Most inspection activities ultimately seek to answer three questions:

Does the organisation understand its pharmacovigilance system?

This means senior staff and the QPPV can describe system boundaries, responsibilities, major processes, and product scope without recourse to the document alone. Inspectors will test verbal knowledge against documentary evidence.

Inspection relevance: Expect inspectors to ask high-level questions first (system description, reporting pathways, major vendors) and then request documentary evidence. A dissonance between verbal answers and the PSMF raises immediate concerns.

Evidence examples: QPPV interview notes, documented organisational charts, responsibility matrices, summary flow diagrams.

Does the organisation control its pharmacovigilance system?

Control is demonstrated by written procedures, assignment of responsibilities, change control, vendor contracts, KPIs and active oversight. Control implies timely identification, escalation and mitigation of risks.

Inspection relevance: Inspectors review controls (SOPs, agreements, audit records, CAPAs) and validate whether these controls operate effectively in practice.

Evidence examples: SOPs with effective dates, vendor SLA reports, KPI dashboards, CAPA trackers showing completion and effectiveness checks.

Can it demonstrate that control?

Demonstration requires traceable documentary evidence: meeting minutes, action logs, audit reports, corrective actions, system logs and version histories. Demonstrability is the bridge between governance and inspection findings.

Inspection relevance: Inability to provide evidence on request is often cited; evidence should be organised, indexed and easily retrievable.

Evidence examples: Indexed PSMF annexes, evidence packs for recent major changes, consolidated evidence matrix mapping PSMF claims to supporting documents.

Every item within this checklist supports one or more of these objectives.

Section 1: Governance Readiness

Effective governance is the foundation of PSMF inspection readiness. Governance encompasses clear ownership, documented responsibilities, routine review mechanisms and a demonstrable escalation and decision-making trail.

Ownership

Confirm:

• PSMF ownership is formally assigned.
• Responsibilities are documented.
• Annex owners are identified.
• Escalation pathways are defined.

Explanation

• Regulatory & inspection context: GVP Module II expects that the PSMF identifies responsible persons and describes governance arrangements. Inspectors will seek to identify who is accountable for content and maintenance of the PSMF and each annex.
• Practical implementation: Appoint a single accountable owner of the PSMF (often within the PV head office) and named owners for each annex (local/regional PV lead, vendor QA, IT owner etc.). Record these assignments in a PSMF governance table and in the master document control system.

Concrete examples

• Single owner: "Head of Global Pharmacovigilance" named with contact details and delegated authority statement.
• Annex owners: Annex 1 (Organisational Structure) — Global HR Lead; Annex 2 (Product List) — Product Portfolio Manager; Annex 5 (Vendor List) — Outsourcing Oversight Manager.

Inspection relevance

• Inspectors often ask to see the PSMF owner or their delegate and may request evidence of delegated authorities. Owners should be prepared to explain how they oversee annex maintenance and how they are notified of relevant changes (e.g., product acquisition).

Sample evidence templates

• Ownership Table (sample fields)
• Document or Annex
• Owner Name
• Job Title
• Department
• Contact details (phone/email)
• Delegation document reference (if delegated)
• Date of assignment
• Signature / approval date
• Delegation of Authority sample:
• Delegator name/title
• Delegate name/title
• Scope of delegation
• Effective dates
• Signature and document control number

Governance Reviews

Confirm:

• Reviews occur according to schedule.
• Review outcomes are documented.
• Significant issues are escalated.
• Actions are tracked to completion.

Explanation

• Regulatory & inspection context: Routine governance reviews (management reviews, PV committee meetings) are expected as part of a quality system (GVP Module I). Inspectors will examine whether governance activities result in documented decisions and follow-up.
• Practical implementation: Maintain a calendar of recurring governance activities (monthly PV operations meetings, quarterly pharmacovigilance governance committee, annual PSMF review). Each review should have an agenda, attendance list, minutes, action items and a tracked closure.

Concrete examples

• Quarterly PV Governance Committee: agenda includes review of KPIs, outstanding CAPAs, vendor performance, regulatory changes affecting PSMF.
• Annual PSMF Review Log: records date, reviewer, scope of review, changes identified, and approval signature.

Inspection relevance

• Inspectors will request recent meeting minutes and evidence that identified issues were actioned and closed. Recurrent overdue actions raise concerns about governance effectiveness.

Sample evidence templates

• Governance Meeting Minutes (sample fields)
• Meeting date/time
• Attendees and roles
• Agenda items
• Key discussion points
• Decisions made
• Action items (owner, due date, status)
• Reference to PSMF sections reviewed
• Approver signature/date
• Governance Review Tracker
• Review ID
• Date of review
• Sections of PSMF reviewed
• Findings
• Actions assigned (owner/due date/status)
• Closure evidence (e.g., updated document versions, emails)

Section 2: QPPV Readiness

The QPPV is central to EU pharmacovigilance accountability. Readiness includes accurate contact information, documented deputy arrangements and demonstrable awareness of the system and risks.

QPPV Information

Verify:

• Name is correct.
• Contact details are current.
• Location information is correct.
• Deputy arrangements are documented.

Explanation

• Regulatory context: EU law requires a QPPV resident in the EEA with responsibility for establishing and maintaining the PV system. The PSMF must contain current contact details for the QPPV and any deputies. Inspectors will seek direct contact details and may call or interview the QPPV.
• Practical implementation: Keep QPPV contact details in the PSMF front matter and ensure they match regulatory records submitted to authorities. Document clear deputy arrangements with signed delegation statements and availability expectations (on-call rotas).

Concrete examples

• QPPV contact listing: name, business phone, mobile phone, secure email, postal address, time zone, availability hours, deputy names with contact details.
• Deputy arrangement: "Deputy QPPV empowered to sign CIOMS reports in the QPPV's absence for a period up to X days with supporting delegation log."

Inspection relevance

• Inspectors may attempt to contact the QPPV or request an interview. Mismatch between regulatory submissions and PSMF entries often leads to immediate queries.

Sample evidence templates

• QPPV Contact & Delegation Card
• QPPV name and registration details
• Direct phone, backup phone, email
• Geographic location and time zone
• Deputies (names, contact details, scope of delegation)
• Evidence of delegation (signed letter, HR record)
• Currency stamp (last verified date)
• QPPV Availability Log
• Date/time of contact attempts
• Outcome (contacted/not contacted)
• Notes (reason for contact/interview summary)

QPPV Awareness

Confirm the QPPV can explain:

• Organisational structure.
• Vendor oversight model.
• Product scope.
• Governance arrangements.
• Major compliance risks.

Explanation

• Regulatory & inspection context: Inspectors expect the QPPV to be knowledgeable and a credible leader for the PV system. Awareness is not limited to high-level knowledge but requires familiarity with operational controls, major vendors, critical products and current compliance issues.
• Practical implementation: Conduct and document periodic QPPV briefings and tabletop exercises; maintain a QPPV briefing pack summarising key metrics, recent audit findings, high-risk products, and active CAPAs.

Concrete examples

• QPPV briefing pack contents: organogram, top 10 products by EEA exposure, critical vendor list, recent PV inspection outcomes, current CAPAs with status, KPI dashboard.
• Simulation: QPPV participates in a mock inspection where they are asked to describe the PV governance for a recently acquired product and show relevant annexes and contracts.

Inspection relevance

• Inspectors may test the QPPV with scenario-based questions: "If you receive a serious unexpected adverse reaction from country X, who do you contact?" The QPPV should answer with the exact pathway and supporting documents.

Sample evidence templates

• QPPV Briefing Pack (content checklist)
• System overview (1-page)
• Current PSMF version and change history
• Product inventory highlights
• Vendor and system inventory
• Audit and inspection status
• Top risks and mitigations
• QPPV Interview Log
• Date/time of interview
• Interviewer(s)
• Topics covered
• Summary of QPPV responses
• Follow-up actions (if any)

Section 3: Product Inventory Readiness

The product inventory is a critical annex. It must accurately and promptly reflect the organisation's marketing and safety responsibilities.

Product Scope

Verify:

• All products are included.
• Marketing status is current.
• Acquired products are incorporated.
• Divested products are removed appropriately.

Explanation

• Regulatory & inspection context: PSMF must list products under the MAHs' responsibility and describe the pharmacovigilance system for those products. Inspectors will cross-check product lists with regulatory databases, MA records and the product marketing status.
• Practical implementation: Maintain a master product register with fields for product name, INN, MA number, MA holder, marketing authorisations by country, authorised indications, licence status (active/suspended/withdrawn), and date of last update. Set trigger events (acquisition, MA transfer, MA renewal) that require inventory updates.

Concrete examples

• Acquisition: If Company A acquires a portfolio from Company B, an immediate PSMF update should list the new products, transitional PV arrangements, and an annex describing the integration plan and timelines.
• Divestment: When a product is transferred out, evidence should show transfer of PV responsibilities, updated MA records and confirmation of removal from PSMF.

Inspection relevance

• Inspectors will request evidence that product responsibilities match regulatory records and that the organisation can demonstrate control for each listed product (e.g., safety reporting obligations met, signal management in place).

Sample evidence templates

• Product Inventory Table (sample fields)
• Internal product code
• Brand name(s)
• Generic/INN
• MA number(s)
• MA holder(s)
• Marketing status by region/country
• Date added to inventory
• Last verification date
• Notes (e.g., transitional arrangements)
• Product Change Notification Log
• Event type (acquisition/transfer/withdrawal)
• Date of event
• Actions initiated (e.g., contract updates)
• PSMF sections affected
• Evidence attached (transfer agreements, MA changes)

Reconciliation

Confirm:

• Product inventories are periodically verified.
• Discrepancies are investigated.
• Evidence of review exists.

Explanation

• Practical implementation: Reconcile product inventory regularly with commercial product lists, regulatory filings, global MA databases and local affiliates. Use reconciliation schedules and evidence of queries/resolutions.

Concrete examples

• Monthly reconciliation report between PV product list and Global Commercial Master Data.
• Discrepancy: affiliate lists a product as marketed in Country X but MA database shows no active MA — initiation of investigation and corrective action.

Inspection relevance

• Inspectors often focus on how organisations detect and resolve inventory discrepancies. Reconciliation records demonstrate control and responsiveness.

Sample evidence templates

• Reconciliation Log (sample fields)
• Reconciliation period
• Source systems compared
• Discrepancy description
• Owner of investigation
• Resolution and date
• Evidence attached (screenshots, emails)

Section 4: Vendor Readiness

Outsourced PV activities are a frequent inspection focus. A complete vendor inventory, current contracts, documented oversight and evidence of effective QA are essential.

Vendor Inventory

Verify:

• All PV vendors are listed.
• Activities are accurately described.
• Critical vendors are identifiable.
• Oversight owners are assigned.

Explanation

• Regulatory context: GVP emphasises oversight of contracted activities. The PSMF should list vendors and the activities they perform (case handling, signal detection, aggregate reporting, clinical safety support, etc.).
• Practical implementation: Maintain a vendor master register with scope of services, contract reference, criticality rating (e.g., high/medium/low), location, contact details and oversight owner. Mapping outsourced activities to PSMF responsibilities is critical.

Concrete examples

• Critical vendor: Safety database provider hosting the global ICSR repository — rated "high criticality" and subject to full periodic audit.
• Non-critical vendor: Translation services for safety reports — rated "low" with periodic quality checks.

Inspection relevance

• Inspectors request contracts, oversight evidence, KPIs and audit reports for high-criticality vendors. Absence of such records is a common inspection finding.

Sample evidence templates

• Vendor Master Table (sample fields)
• Vendor name
• Service description
• Contract reference and effective/expiry dates
• Criticality rating
• Single point of contact
• Oversight owner
• Service locations (country/data residency)
• Regulatory considerations (e.g., data transfer agreements)
• Vendor Map (visual)
• Process flow showing which vendors support each PV process (case intake, triage, database entry, reporting, signal detection, aggregate reporting)

Oversight Evidence

Confirm:

• Vendor oversight activities occur.
• Reviews are documented.
• Performance is monitored.
• Significant issues are escalated.

Explanation

• Practical implementation: Oversight should include initial vendor qualification, periodic performance reviews, KPIs/SLA monitoring, periodic audits (on-site or remote), CAPAs and contract governance. Ensure evidence is date-stamped and linked to the vendor record.

Concrete examples

• KPI examples: case processing timeliness (median days from receipt to entry), query closure rate, audit findings closed within agreed timelines.
• Oversight activity: Quarterly KPIs reviewed at a Vendor Performance Meeting with minutes, and an annual audit report attached to the vendor file.

Inspection relevance

• Inspectors will look for evidence of both planned oversight (audit schedule, KPIs) and reactive oversight (responses to late processing, data quality issues). They will expect clear KPI thresholds and evidence of remedial actions.

Sample evidence templates

• Vendor Oversight File Outline
• Contract and SOW
• Initial due diligence (vendor questionnaires, risk assessment)
• KPIs and performance reports
• Audit reports and evidence of corrective action
• Communication log (escalations, change requests)
• Data transfer/security agreements
• KPI Dashboard (sample metrics)
• Metric name
• Target
• Current performance
• Trend (3-6 months)
• Action required (if underperforming)

Section 5: Organisational Structure Readiness

Organisational clarity supports rapid, accurate responses during inspections and daily PV operations.

Verify:

• Reporting lines are current.
• Key roles are represented.
• Affiliate structures are accurate.
• Governance committees are reflected correctly.

Explanation

• Practical implementation: Maintain an organisational chart that reflects current reporting lines and dotted-line accountabilities. Ensure affiliate PV leads and contact points are current and aligned with the vendor and product inventories.

Concrete examples

• Organogram with names for PV Head Office, QPPV, deputies, global safety operations head, signal management lead, local PV contacts for each affiliate.
• Responsibility Assignment Matrix (RACI) showing who is Responsible, Accountable, Consulted, and Informed for key PV processes (ICSR processing, PSUR submission, signal detection).

Inspection relevance

• Inspectors expect the organisation chart and RACI to be consistent with who performs activities in practice. Contradictions between organograms and actual operational practice are of interest.

Sample evidence templates

• Organisational Chart (current)
• Name, role, function, contact details
• Effective date
• RACI Matrix (sample rows)
• Process (e.g., ICSR receipt)
• Responsible (e.g., Safety Case Management Team)
• Accountable (e.g., PV Head)
• Consulted (e.g., Regulatory Affairs)
• Informed (e.g., QPPV)

Section 6: System Inventory Readiness

Technical systems underpin PV operations. The PSMF should list systems, owners, validation status and data flows.

Verify:

• Safety databases are listed.
• Reporting platforms are listed.
• Signal management systems are listed.
• Retired systems have been removed.

Explanation

• Regulatory context: PSMF must identify IT systems used for pharmacovigilance activities and provide evidence of their validation and suitability for intended use. Inspectors will check system versions, hosting arrangements, validated status and data migration records.
• Practical implementation: Maintain a system inventory with fields for system name, vendor, version, purpose, hosting location, validation status, backup and retention arrangements, and owner. For cloud-hosted or third-party systems, include evidence of supplier audits and security assessments.

Concrete examples

• Safety database: "Global Safety DB v4.2 — vendor XYZ — validated 2024-05-10 — production cutover 2024-06-01 — owner: PV IT Systems Manager."
• Decommissioned system: "Legacy Case System 'LegacyDB' — retired 2023-10-31 — migration report and archive verification attached."

Inspection relevance

• Inspectors may ask for validation packages, change logs and evidence of data integrity (audit trails). They may request screenshots demonstrating how safety reports are entered and how line listings are produced.

Sample evidence templates

• System Inventory Table (sample fields)
• System name
• Vendor and version
• Purpose (ICSR, signal detection, aggregate reporting)
• Hosting and data residency
• Validation status and report reference
• Backup and retention
• Owner and contact
• Change control log reference
• System Validation Summary
• Validation owner
• Summary of validation activities (IQ/OQ/PQ)
• Acceptance criteria and results
• Known limitations and mitigations
• Date signed off

Section 7: Annex Readiness

Annexes provide the detailed evidence that supports the PSMF claims. Inspectors will typically request annexes relevant to topics under review (product lists, vendor files, SOP inventory, audit history).

Annex Completeness

Verify:

• Required annexes exist.
• Annexes are accessible.
• Annexes are version controlled.

Explanation

• Practical implementation: Create an annex index in the PSMF with version history and ownership for each annex. Access controls should ensure stakeholders can retrieve annexes quickly during an inspection. Annexes should be consistently formatted and searchable.

Concrete examples

• Common annexes: Annex A — Organisational structure; Annex B — Product list; Annex C — PV SOPs; Annex D — Vendor list and contracts; Annex E — System inventory; Annex F — Audit reports and CAPAs; Annex G — Training records; Annex H — Agreements and delegations (QPPV & deputies).
• Versioning: Annex C v2.3 (effective 2025-11-01) — SOP index updated to include revised case processing SOP.

Inspection relevance

• Inspectors may request any annex. Absence, poor format or lack of version control will be noted. Annexes must be complete and demonstrate the claimed controls.

Sample evidence templates

• Annex Index Template
• Annex ID
• Title
• Owner
• Version
• Effective date
• Location (URL/file path)
• Notes on recent changes
• Annex Access Log
• Date/time accessed
• User
• Purpose (e.g., inspection request)
• File version accessed

Annex Accuracy

Verify:

• Information remains current.
• Inventories align with reality.
• Recent changes are reflected.

Explanation

• Practical implementation: Implement periodic review cycles for each annex (e.g., product list monthly, vendor files quarterly, SOP index annually). Use change control to capture amendments and link annex updates to source evidence (contracts, MA documents, audit results).

Concrete examples

• Accuracy check: Cross-reference the annex product list with regulatory authority databases and local affiliate MA files monthly. Record the verification in the annex review log.

Inspection relevance

• Inspectors will verify the accuracy of annexes with external sources (e.g., national competent authorities) and operational staff. Discrepancies often prompt deeper examination.

Sample evidence templates

• Annex Review Checklist
• Annex name
• Review date
• Reviewer name/title
• Sections checked
• Discrepancies identified
• Actions required
• Evidence attached (screenshots, emails)
• Annex Change Log
• Change description
• Rationale
• Related document references
• Approver
• Effective date

For additional guidance see:

[[psmf-annexes-guide]]

Section 8: Change Control Readiness

Change control is the mechanism that keeps the PSMF accurate over time. A robust change control system ensures updates are identified, risk-assessed and executed with traceability.

Verify:

• Significant changes trigger review.
• PSMF impact assessments occur.
• Updates are documented.
• Approvals are retained.

Explanation

• Regulatory context: Any major change to the PV system (e.g., transfer of MAs, outsourcing of core PV functions, change of QPPV) requires updates to the PSMF and may need regulatory notifications. GVP guidance expects change control to be embedded in PV quality systems.
• Practical implementation: Define a PSMF impact assessment workflow within the global change control system. Include thresholds for immediate PSMF updates (e.g., transfer of responsibility, critical vendor changes) and a timeline for non-critical updates. Ensure change requests include a risk assessment of patient safety impact and timeline for PSMF amendment.

Concrete examples

• Trigger events: acquisition of a product line, replacement of safety database, change in QPPV, outsourcing ICSR processing to a new vendor.
• Change control record: "Change ID 2026-042 — Safety database migration — PSMF sections affected: Systems, Annex E, Vendor Annex D — Impact assessment completed 2026-04-10 — PSMF update scheduled prior to cutover."

Inspection relevance

• Inspectors will examine how changes were managed, who reviewed and approved updates and whether the PSMF and operational practice remained aligned during transitions. Evidence of a controlled cutover reduces inspection risk.

Sample evidence templates

• Change Control Impact Assessment (sample fields)
• Change ID and title
• Description of change
• Date raised
• Initiator and contact
• PSMF sections potentially affected
• Risk assessment (patient safety, regulatory, data integrity)
• Required actions (update PSMF, notify authorities)
• Approval (name/date)
• Completion evidence (links to updated documents)
• PSMF Update Log
• PSMF section updated
• Change control reference
• Summary of update
• Effective date
• Approver name/title

For additional guidance see:

[[psmf-maintenance-and-change-control]]

Section 9: Audit and CAPA Readiness

A structured audit programme and an effective CAPA system demonstrate an organisation's ability to identify, prioritise and resolve PV deficiencies.

Audit Programme

Verify:

• Planned audits occur.
• Audit schedules are current.
• Findings are tracked.

Explanation

• Practical implementation: Maintain an annual audit plan covering internal audits, vendor audits and regulatory inspections. Audits should be risk-based; higher-risk processes or vendors have higher audit frequency. Audit reports must include findings, root cause analysis, corrective actions and verification of effectiveness.

Concrete examples

• Annual plan includes: annual internal audit of global ICSR process, biennial audits of top 3 vendors, and targeted audits following major system implementations.
• Audit report: find root cause, propose CAPA, assign owner, set deadlines and specify verification steps.

Inspection relevance

• Inspectors will review the audit schedule, sample audit reports and CAPA closure evidence. Repeated findings or ineffective CAPAs are frequently highlighted during inspections.

Sample evidence templates

• Audit Plan Template
• Audit ID
• Scope
• Audit type (internal/vendor)
• Frequency
• Responsible auditor
• Scheduled date
• Audit Report Template
• Executive summary
• Objectives and scope
• Methodology
• Findings (categorized by severity)
• Root cause analysis
• CAPA plan (owner/due date)
• Evidence of closure and effectiveness

CAPAs

Verify:

• CAPAs remain current.
• Overdue actions are visible.
• Effectiveness checks occur.

Explanation

• Practical implementation: Use a CAPA tracker with dashboards showing open actions, due dates, overdue items and effectiveness metrics. Root cause analyses should be documented and used to drive systemic fixes rather than temporary workarounds.

Concrete examples

• CAPA tracker shows corrective action to retrain staff on case intake SOP, with verification via a sample audit showing reduced intake errors.
• Effectiveness check: re-audit of process three months after CAPA closure demonstrating sustained compliance.

Inspection relevance

• Inspectors scrutinise CAPA timelines, closure evidence and the robustness of effectiveness checks. Superficial CAPAs or lack of follow-up is a common deficiency.

Sample evidence templates

• CAPA Tracker (sample fields)
• CAPA ID
• Finding reference (audit/inspection/complaint)
• Description of root cause
• Corrective actions
• Preventive actions
• Owner
• Start date
• Due date
• Status
• Effectiveness check date/results

Section 10: Inspection Readiness Assessment

A structured readiness assessment provides a final gate before an inspection. It should be evidence-based and produce a remediation plan for any gaps.

Ask the following questions.

Accuracy

Does the PSMF accurately reflect the current system?

Explanation and evidence

• Verify that the PSMF content matches current SOPs, contracts, system configurations and organisational charts. Evidence: side-by-side matrix mapping PSMF statements to source documents (e.g., "PSMF: Vendor X performs ICSR entry" => "Contract Annex 1; Vendor SOP v2; KPI report").

Template

• Accuracy Mapping Matrix
• PSMF statement
• Source document(s) & location
• Date verified
• Verifier name

Completeness

Is all required information available?

Explanation and evidence

• Check that mandatory PSMF sections and annexes exist and are populated (QPPV details, product list, vendor list, system inventory, SOP index). Evidence: PSMF completeness checklist with status for each required item per GVP Module II.

Template

• Completeness Checklist
• Required element (per GVP)
• Present (Y/N)
• Version/date
• Owner
• Notes

Traceability

Can information be verified quickly?

Explanation and evidence

• Organise the PSMF with hyperlinks, annex indices and an evidence index that maps claims to documents. Evidence: evidence index, retrieval times from document management system measured during a mock request.

Template

• Evidence Index
• PSMF section
• Supporting documents (title/reference)
• File path/URL
• Retrieval time (tested)
• Notes

Governance

Are oversight activities documented?

Explanation and evidence

• Confirm that meetings, reviews, KPIs, audits and vendor oversight are documented, with decisions and actions traceable. Evidence: governance meeting minutes, KPI reports, audit schedules and CAPA files.

Template

• Governance Evidence Pack (contents)
• Recent governance meeting minutes
• KPI dashboards (last 6 months)
• Audit and inspection history
• CAPA tracker snapshot

Sustainability

Would the PSMF remain accurate if inspected tomorrow?

Explanation and evidence

• Test sustainability with a mock inspection or surprise internal review and evaluate time-to-evidence and the quality of responses. Evidence: mock inspection report, list of issues found, remediation timelines.

Template

• Mock Inspection Report
• Scope
• Observations
• Strengths
• Gaps
• Immediate actions
• Longer-term actions

A "no" answer to any of these questions should trigger review.

Inspection relevance

• Regulatory inspectors may perform similar checks; an internal readiness assessment aligned to these questions reduces the risk of adverse findings.

A Simple Readiness Scoring Model

Some organisations find scoring useful.

Example:

Interpretation:

Governance around scoring

• Assign a scoring governance group (e.g., PSMF Steering Committee) to review scores, approve action plans and prioritise remediation. Scores should be evidence-backed, with a short rationale and references to particular evidence items.

Practical implementation

• Use a scoring sheet where each area has well-defined criteria for each score to reduce subjectivity. Store the scoring rationale and link to evidence in the document management system.

Inspection relevance

• Scoring is primarily an internal governance tool. However, regulators may request summary assessments (e.g., internal audit outcomes) and seeing a mature scoring framework with governance demonstrates proactive control.

What Mature Organisations Do Differently

High-performing organisations:

• Review continuously.
• Integrate governance and maintenance.
• Assign ownership clearly.
• Monitor metrics.
• Treat inspection readiness as a daily activity.

Expanded explanation

• Continuous review: embed PSMF tasks into routine operations (e.g., product reconciliation as part of monthly commercial data reviews).
• Governance integration: ensure PSMF updates are considered in wider change control, M&A, regulatory submissions and IT change management.
• Clear ownership: owners at annex and section level with SLA expectations for updates.
• Monitor metrics: maintain a readiness dashboard (e.g., percent of annexes reviewed in last 12 months, number of overdue CAPAs).
• Daily activity: maintain an "inspection pack" that is updated continuously rather than assembled ad-hoc.

Inspection relevance

• Inspectors value organisations that can present coherent governance narratives supported by continuous metrics and living evidence. One-off remediation projects just before inspection increase risk and typically attract closer scrutiny.

Key Takeaways

• Inspection readiness reflects governance quality rather than document quality alone.
• Product inventories and vendor inventories are common risk areas.
• QPPV awareness remains a critical inspection consideration.
• Annexes require continuous maintenance.
• Change control is essential for long-term accuracy.
• Audits and CAPAs provide evidence of system effectiveness.
• Mature organisations maintain readiness continuously rather than preparing only before inspections.

Final note on evidence management

• Maintain an evidence index that maps PSMF assertions to primary documents. Evidence should be date-stamped, version-controlled and retained according to retention policies. During inspections, provide concise evidence packs that directly support the question asked rather than voluminous un-indexed folders.

References

1. EMA Good Pharmacovigilance Practices (GVP) Module II – Pharmacovigilance System Master File.
2. EMA Good Pharmacovigilance Practices (GVP) Module III – Pharmacovigilance Inspections.
3. EMA Good Pharmacovigilance Practices (GVP) Module I – Pharmacovigilance Systems and Their Quality Systems.
4. Regulation (EC) No 726/2004.
5. Directive 2001/83/EC.
6. Commission Implementing Regulation (EU) No 520/2012.
7. EMA Questions and Answers on Pharmacovigilance System Master Files.

References

1. European Parliament and Council. Directive 2001/83/EC, as amended, particularly Articles 8 and 104. urlEUR-Lex — Directive 2001/83/EChttps://eur-lex.europa.eu/eli/dir/2001/83/oj
2. European Commission. Commission Implementing Regulation (EU) No 520/2012, consolidated version applicable from 12 February 2026. urlEUR-Lex — Implementing Regulation 520/2012https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02012R0520-20260212
3. European Medicines Agency. GVP Module I — Pharmacovigilance systems and their quality systems. urlEMA — GVP Module Ihttps://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-i-pharmacovigilance-systems-and-their-quality-systems_en.pdf
4. European Medicines Agency. GVP Module II — Pharmacovigilance system master file, Revision 2. urlEMA — GVP Module II Rev. 2https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-ii-pharmacovigilance-system-master-file-rev-2_en.pdf

Regulatory Note

This article is educational. Binding obligations arise from applicable legislation and marketing-authorisation conditions. GVP and national-authority publications describe regulatory expectations. Suggested models, frequencies, thresholds, scorecards, matrices, checklists and scenarios are illustrative or recommended practice unless a legal provision is expressly identified.

Commission Implementing Regulation (EU) No 520/2012 was amended; use the consolidated text applicable from 12 February 2026 with current guidance. EMA states that affected GVP modules will be revised. Verify current legislation, guidance, national requirements, contracts and product-specific commitments before operational use.