PV system and the Swissmedic inspection

The pharmacovigilance system and the Swissmedic inspection

A pharmacovigilance system is a described organisation with trained people, written procedures, a case database, deadline control, a deviation and CAPA process, current PV agreements and an archive. An inspection tests whether the described system is the one you run, starting from the system description and ending in the case log.

Last reviewed: 2026-09-17

Reading time: 5 min

Reviewed by Swiss Pharmacovigilance

System description and PSMF

The pharmacovigilance system master file is the EU construct for describing a system: organisation, roles, processes, databases, providers, contracts, and a log of changes. Switzerland requires the system to be described and the description kept current. A Swiss annex covering the RPPV, ElViS access, the SDEA overview and the Swiss SOPs has proved its worth in inspections.

The components of a working system

Eight components, all of which have to exist and be evidenced. A system missing any one of them fails not because a box is unticked but because the missing piece breaks something downstream: no deadline control means late cases, no training means a lost day 0.

A written system description, kept current, with a change log
SOPs covering every process that carries a deadline or a decision
Trained staff, with dated records, including non-PV functions
A case database or a validated equivalent, with an audit trail
Deadline monitoring that flags before the deadline, not after
A deviation and CAPA process with effectiveness checks
Signed, current PV agreements with every relevant partner
An archive that is readable, complete and retrievable within a day

The SOPs you actually need

SOP libraries fail in two directions: too thin to cover the deadlines, or so large that nobody reads them. Eight documents cover a Swiss system for a small to mid-sized portfolio. Each one needs a version, a date, an approval and a named owner.

Case intake, processing and submission, including the day 0 rule
Deadline monitoring and escalation for cases at risk
Literature search and assessment
Signal management from detection to closure
Periodic safety reports: planning, writing, review, submission
Training: who, what, how often, and how it is evidenced
Deviations, CAPA and effectiveness checking
Business continuity, including the ElViS outage fallback

Training: who, how often, what evidence

Training is where systems quietly fail. The people who lose a day 0 are almost never in the PV department: they are in the field force, at medical information, in marketing or at a distributor. Everyone with patient or customer contact needs to know what a report looks like and that it goes on within 24 hours, to a named address.

Evidence means dated attendance lists, a content outline, and a defined repeat interval, typically on joining and annually thereafter. A slide deck with no attendance record is not evidence, and an inspection will say so.

What the inspector asks, and where the answer lives

Inspections are predictable in structure. The table below maps the usual questions to the artefact that answers them; if a row has no location in your organisation, that is your gap list.

Inspection topics, the evidence requested and where it lives
Inspection topic	What the inspector asks for	Where it lives
System and roles	The system description and the RPPV appointment	System description, appointment letter
Day 0	The source document for a sampled case	Case file, intake record, e-mail trail
Deadlines	The list of breaches and their root causes	Deadline report, deviation log
Expectedness	The product information version used	Case file, regulatory document archive
Signals	The signal log with decisions and reasoning	Signal log, assessment reports
Literature	The documented search strategy and hit log	Literature SOP, search records
Training	Attendance records for the field force	Training file
Partners	The SDEA and the latest reconciliation	Contract file, reconciliation records
Continuity	The ElViS outage procedure and any use of it	Continuity SOP, incident record

Twelve weeks to an inspection

Announced inspections give you time that is easy to waste. Spend it on the case log rather than on the presentation, because that is where the findings come from.

Week 12: confirm scope and dates, name the inspection lead and the room owners.
Week 11 to 9: self-inspect the case log, sample cases end to end and list the gaps.
Week 9 to 6: close what can be closed, open CAPAs for what cannot, with dates.
Week 6 to 4: refresh the system description, the SOP index and the training file.
Week 4 to 2: run a mock inspection with someone outside the process asking the questions.
Week 2 to 1: prepare the document room and rehearse retrieval within minutes.
Week 0: run the inspection with a scribe, a daily wrap-up and no improvised answers.

Findings and CAPA

A finding is not a verdict, it is a task with a deadline. What determines the outcome is the quality of your response: a genuine root cause rather than a restatement of the symptom, a correction, a preventive measure, an owner, a date, and an effectiveness check that closes the loop. A CAPA closed without an effectiveness check is not closed, and the next inspection will reopen it.

Frequently asked questions

Do we need a PSMF for Switzerland?

The PSMF as such is an EU requirement. Switzerland requires the system to be described and kept current. Using your PSMF plus a Swiss annex covering the RPPV, ElViS access, SDEAs and Swiss SOPs is the pragmatic answer and works well in inspections.

How many SOPs do we need?

Enough to cover every process carrying a deadline or a decision, which for a small to mid-sized portfolio is around eight documents. More is not better: an SOP nobody follows is a finding, not a control.

Who has to be trained?

Everyone whose work could put them in contact with a safety report: PV, medical information, field force, marketing, quality, regulatory and management, plus distributors under an SDEA. Content and depth differ by role; the 24 hour forwarding rule applies to all of them.

Are inspections announced?

Usually, with enough notice to prepare. Preparing continuously is still cheaper, because the findings come from the case log of the past two years and no amount of notice changes what is in it.

What is a critical finding?

One that indicates the system cannot reliably protect patients, for example systematic late reporting of serious cases or an absent RPPV. It carries a short remediation deadline and usually a follow-up inspection.

Can a service provider be inspected instead of us?

Swissmedic inspects the authorisation holder and can extend the inspection to a provider performing the work. Your contract has to give you audit rights and your file has to show you exercised oversight.