PV audits, mock inspections and training
External providers test your Swiss pharmacovigilance system before Swissmedic does. A gap analysis against Art. 61 ff. TPO, a mock inspection that samples your case log end to end, an SDEA review, a written report with prioritised findings, CAPA support, and role based training for the functions that actually lose a day 0.
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- Reviewed by Swiss Pharmacovigilance
What this service is
An independent examination of your system and its evidence, followed by the training that closes the human gaps it finds. The output is a written report with findings graded by severity and a remediation plan you can work through, not a list of observations.
What you get
- A gap analysis against Art. 61 ff. TPO and the Swissmedic guidance
- A mock inspection sampling cases end to end, back to the source document
- A review of your SOP set for coverage, currency and usability
- An SDEA review, including whether the cascade and reconciliation work
- A written report with findings graded critical, major and minor
- A prioritised remediation plan with owners and realistic dates
- CAPA support, including root cause work and effectiveness checks
- Role based training in German, French and English, with attendance records
How external providers run it
- Scope: products, period, sites and providers in scope, agreed in writing.
- Document review off site: system description, SOPs, training file, SDEAs.
- Case sampling: select cases across the period, including serious and late ones.
- On site or remote interviews with PV, regulatory, field force and management.
- Draft report with graded findings, discussed with you before it is final.
- Remediation planning, then training delivered to the functions that need it.
- Optional follow-up review to confirm the CAPAs are effective.
What external providers need from you
- Read access to the case log and the source documents for the sampled period
- The system description, the SOP set and the training file
- The SDEAs and any reconciliation records
- Access to the people who do the work, not only to their managers
- Any previous inspection reports and open CAPAs
| Offering | Method | Deliverable | Duration |
|---|---|---|---|
| Gap analysis | Document review against the TPO | Gap list with severity and effort | 3 to 5 days |
| Mock inspection | Case sampling plus interviews | Inspection style report, graded findings | 5 to 8 days |
| SDEA review | Contract review plus reconciliation check | Clause gap list per partner | 1 to 3 days |
| CAPA support | Root cause work with your team | CAPA plan with effectiveness checks | 2 to 5 days |
| Field force training | Workshop, case based | Attendance record and material | Half a day per group |
| PV team training | Workshop on Swiss specifics | Attendance record and material | 1 day |
| Management briefing | Briefing on accountability and findings | Slide record and minutes | 2 hours |
Onboarding
- Week 1: scope agreed, confidentiality in place, document request issued.
- Week 2: document review off site, case sample selected.
- Week 3: interviews and case tracing, on site or remote.
- Week 4: draft report discussed, then final report and remediation plan.
- Week 5 onwards: training delivered and CAPA work supported.
Pricing model
Audits and training are day rates, quoted as a fixed number of days per the table above once the scope is agreed. Travel is charged at cost. A follow-up review to confirm CAPA effectiveness is quoted separately, because whether it is needed depends on what the first review finds.
Frequently asked questions
How is a mock inspection different from a gap analysis?
A gap analysis reads your documents and tells you what is missing. A mock inspection tests whether the documented system is the one you run, by sampling cases and tracing them to source. Most real findings come from the second.
What does an audit cost?
A day rate, quoted as a fixed number of days once the scope is set, with travel at cost. The table above gives the usual duration for each offering, so the range is predictable before you commit.
Will the report be used against external providers?
The report is yours and confidential. An honest internal finding with a dated CAPA is a strength in a real inspection; an audit report that found nothing is rarely believed.
Can you audit provider service provider?
Yes, if your contract gives you audit rights. Auditing the provider is often where the useful findings are, particularly on day 0 recording and the cascade deadlines.
In which languages do you train?
German, French and English, and Italian on request. The field force training matters most in the language people actually work in, because the goal is a behaviour change rather than an attendance record.
Do you also help during a real inspection?
Yes. External providers support the preparation, attend, and help draft the responses and the CAPA plan afterwards. That support is quoted as a day rate.
Do you need an RPPV in Switzerland?
We act as the qualified person responsible for pharmacovigilance, run case processing and write the PSURs for your Swiss authorisations.