Audit & Inspection Readiness
A quality system is only as strong as its last audit.
Audit programmes built around each client actual risk profile rather than a generic checklist, with findings that come attached to a way forward.
The problem
Most audit reports are read once and filed.
A report that lists forty findings without ranking them tells leadership nothing they can act on. Everything looks equally urgent, so nothing gets prioritised, and the same findings appear next year with a different date.
The other failure is the comfortable audit. An auditor who wants to be invited back softens the one finding that matters. It feels professional at the time and it is worthless, because the inspector will not soften it.
We rank findings by impact on subject safety and data integrity, attach a practical remediation path to each, and put the uncomfortable one first.
Talk to a specialist
Tell us the problem. A specialist replies, not a form robot.
What we do
What we audit.
Internal system audits
Your quality system against the standard you claim to meet.
Vendor and supplier audits
CROs, labs, CMOs and suppliers, audited to your criteria.
Investigator site audits
Site conduct, consent, source and essential documents.
GCP, GMP and GLP
Scoped to the regulation that actually applies to the activity.
Mock inspections
A rehearsal with the difficulty turned up, before the real one.
CAPA and remediation
Closing findings to effectiveness rather than to a date.
For consultants
Roles we place in audit and quality.
Auditors with genuine inspection experience are scarce, and most are working. This is another discipline where being known matters.
- QA Auditors, GCP GMP and GLP
- Lead Auditors
- CAPA and Complaints Specialists
- Quality Engineers
- Inspection Readiness Leads
- Supplier Quality Specialists
Proof
Ranked
Every finding, by impact on subject safety and data integrity.
Client testimonials for this discipline are being collected and will appear here once approved in writing by the clients concerned.
Questions
Questions we get asked.
Will you tell us things we do not want to hear?
Yes, privately and first. A softened report costs you more than an uncomfortable meeting.
Can you remediate what you find?
Yes, and most clients ask us to. Where independence matters we keep the audit and remediation teams separate and say so in writing.
How far ahead should we start inspection readiness?
Earlier than feels necessary. Most of what a mock inspection finds takes weeks to fix properly and days to fix badly.
Do you audit our vendors on our behalf?
Yes, to your criteria and your quality agreement, with a report your own QA function can stand behind.
What standards do you work to?
ICH GCP, 21 CFR Parts 11, 210, 211 and 820, ISO 13485 and ISO 14971, scoped to the activity. Siri itself holds no ISO certifications; these are the standards we audit against.
Related
Where to go next.
Talk to someone who has done this.
Hiring for it, or looking for the work. Either conversation is welcome.