GVP Auditing and Inspection Readiness
The challenge: Procedures can look compliant on paper without being effective in practice. Gaps in a PV system, whether in human or animal health, tend to surface as findings during a regulatory inspection, not before.
The solution: An independent audit that tests the system against how it actually operates, not how it is documented to operate. Findings are ranked by risk, with a remediation plan attached to each one.
From the Trenches
The Challenge
01
A defensible audit programme needs a risk-based strategy behind it: which systems and partners get audited, how often, and on what basis. Building that logic from scratch is a specialist task most small PV teams have not had to do before, and getting it wrong means either under-auditing or spending audit resource in the wrong places.
The Solution
We build the audit strategy itself: scope, frequency, and risk criteria defined and documented, ready for your team to execute or for us to run on your behalf.
The Challenge
02
Running an audit programme is coordination work as much as technical work: scheduling, contracting independent auditors, overseeing how each audit is conducted, and making sure the resulting documentation fits your QMS. On a small team, this competes directly with the day-to-day PV work the audits are meant to check.
The Solution
We manage the programme end to end: auditor contracting, quality oversight of how each audit is conducted, and documentation delivered in the format your QMS requires.
The Challenge
03
Some audits need to be conducted by people who are demonstrably independent of the system under review, which can rule out internal staff entirely depending on scope and risk level.
The Solution
We conduct the audit itself, using our own auditors or contracted independent auditors matched to the scope and independence requirement of each engagement.
The Challenge
04
Most small PV teams have never hosted a regulatory inspection. When one is announced, gaps in documentation and unclear ownership surface under time pressure, and staff who have never sat across from an inspector are unsure how to conduct themselves in the room.
The Solution
A structured readiness review combined with practical training on how to host an inspection: mock interviews, role clarity on who speaks to inspectors, and document walkthroughs your team can rehearse before the real one arrives.
The Challenge
05
The Solution
The Challenge
06
The Solution
From first contact to ongoing compliance: Our structured three-step process gets you audit-ready with minimal disruption.
For a growing company, an upcoming regulatory inspection can feel like a threat. But it doesn’t have to be. A strategic, risk-based approach to auditing transforms compliance from a reactive burden into a proactive asset. It provides the certainty that your systems are not just compliant today, but resilient for tomorrow’s growth and scrutiny.
Independent pharmacovigilance leadership for small and mid-size pharma and biotech.
Building PV systems for whatever situation put them under strain.
Responsible for leading human health and veterinary PV audits to help organisations build robust, inspection-ready PV systems.
