What we do

How it runs

01
Audit Scoping
With you, we settle why the supplier needs an audit, then the scope, the criteria, the sites, the dates and what you need to receive.
02
Supplier Documentation Review
You share what you already hold, and we request the supplier’s PQS documentation, audit history and data, so the audit looks where the risk is.
03
Audit Planning
We turn the agreed scope into an audit plan and settle the agenda, interviews, sampling and access with the supplier.
04
Audit Execution
At the supplier’s site, we assess systems and processes, interview staff, sample records and collect objective evidence.
05
Conclusions & Reporting
We present our conclusions to the supplier, classify each finding and issue the final report on which you base your qualification decision.
06
CAPA Follow-Up
If the follow-up is in scope, we review the supplier’s CAPA response and evidence and tell you whether the supplier has closed each finding.

Yes. If you have your own procedures, checklists and report format, we run the audit against them and deliver the report in your format. If you do not, we use ours and hand them over with the report.
We agree the criteria with you in the scoping call and write them into the audit plan. They can be EU GMP and its annexes, GACP, the relevant GxP, your own quality agreement, or a combination of them. We assess only against criteria agreed in advance.
Yes, once you have introduced us. We send requests, the agenda and documents through one channel agreed with you, and we copy you on every request and document we send the supplier.
We classify each finding as critical, major or minor, state the objective evidence behind it and the requirement it refers to, and present it to the supplier at the closing meeting, before we issue the report.
We fix the date with you in the scoping call and write it into the audit plan alongside the deliverables, before the audit starts. If the report has to fit a qualification schedule, raise it in that call.
Yes, when it is in scope. We review the supplier’s corrective actions and the evidence behind them, and tell you which findings the supplier has closed and which remain open.
We record it in the report as a limitation of scope, against the part of the audit it affected. The report states what we could not assess and why, so you decide on what we saw.