When someone leaves, your compliance should not leave with them.
Every departure takes weeks of accumulated knowledge with it. Every new hire costs just as much to rebuild it. My Audit Corner is the living memory of your system — the one that never hands in its resignation.
A risk no one budgets for — but everyone pays.
In an RA/QA team, knowledge doesn't live in the manuals. It lives in people's heads: which documents were recently updated, which ones carry a non-conformity history, where the IVDR transition stands, which Technical File is fragile before the audit. That informal knowledge, accumulated over months — sometimes years — is nearly impossible to transfer, especially when the document repositories contain several thousand files.
When someone leaves
Whether it's a resignation, a sick leave, or a maternity leave, the person takes their understanding of the system with them: the real state of the documentation, the implicit priorities, the document dependencies no one else knows about. The handover window is always too short, and the successor inherits a system they don't yet understand.
When someone arrives
The new hire takes weeks — sometimes months — to build enough visibility on the QMS and the Technical Files to be truly operational. They don’t know what to prioritize, they don’t know the real compliance state, and they spend considerable time asking questions of colleagues who are already overloaded.
When the absence is temporary
The trickiest scenario. A three-month sick leave, a maternity leave: you don't hire, you wait. And meanwhile, files stop progressing, deadlines get closer, and no one has the visibility to pick up ongoing topics.
RA/QA turnover: a risk multiplier.
Longer time-to-market
Every month of unproductive onboarding pushes back your CE marking deadlines. On a portfolio of 60 Technical Files, a quarter of drift can shift an entire product roadmap.
Non-compliance risk
Without visibility on the real state of the system, gaps go unnoticed. Documentation inconsistencies pile up. And the external audit is coming.
Overload on the remaining team
The person who stays absorbs the questions, trains the new hire, and continues their own files. The risk of error skyrockets — and the next resignation is never far away.
Direct financial cost
Between recruiting, months of ramp-up, colleagues dedicated to training, and consultants called in to cover the gap: the real cost of an RA/QA turnover runs into tens of thousands of euros per position.
What your peers deal with every day.
"Thanks, but right now I first need to get up to speed on what exists before thinking about improvements. I'm so absorbed by the pharma side that on the medical device side, I have little time left before our QARA lead leaves."
— RA/QA officer, newly hired at a medical device manufacturer
"We have a key resource on sick leave for three months, not replaced. And meanwhile, 60 IVDR files are stalled, with end-2028 deadlines approaching."
— Regulatory Affairs Manager, IVD manufacturer
"My maternity leave will impact the calendar. We need to discuss replacement and continuity internally, but no one has visibility on the real state of our files."
— Head of Quality, medtech startup
"50% of our regulatory department’s time is spent handling repetitive internal requests. Half our day is spent answering the same questions."
— Regulatory Affairs Manager, IVD manufacturer
My Audit Corner — the team member who never leaves.
MAC doesn't replace your experts. It ensures their knowledge stays accessible, even once they are gone. As soon as it connects to your documentation, MAC maps, analyzes, and maintains a living status view of your entire documentation system.
Someone leaves: zero knowledge loss
Your reality
The handover happens in a few days at best. Entire parts of the system stay in the dark.
The MAC solution
The status review is permanent and independent from individuals. The compliance dashboard, per-clause scores, document dependencies — everything is there, updated continuously. Whoever takes over inherits a complete, current snapshot of the system.
How it works, concretely.
Smart QMS
Your institutional memory
Permanent status view of your QMS. ISO 13485 compliance score per clause. Automatic detection of inconsistencies between documents. The new hire sees at a glance where the system stands — without asking anyone.
Ask MAC
The colleague who knows everything
A conversational assistant connected to your documentation. It answers operational questions, surfaces relevant procedures, and points to the right documents. Available 24/7, it never goes on vacation.
"Having a software that records the answers already given and automatically serves them back through a chatbot grounded in company data — that's exactly what we need."
Action plan
The day-one roadmap
A prioritized, always-up-to-date action plan with assignable tasks and pre-filled content. The new hire doesn’t start with a blank page — they start with a roadmap.
Technical File
Portfolio visibility
Every Technical File is analyzed, scored, and its gaps are identified. When a product owner leaves, their successor doesn’t inherit a black box — they inherit a full diagnostic.
Impact at every level of the organization.
Leadership / HR
- RA/QA turnover is no longer a strategic risk — it’s a managed event
- Time-to-market is no longer held hostage by a departure
- Onboarding costs drop drastically
- Compliance is guaranteed regardless of team movements
RA/QA teams
- No more marathon, incomplete handovers
- No more time wasted answering the same questions
- New colleagues become autonomous faster — less load on those who stay
- Team knowledge is capitalized, not lost
My Audit Corner is the team member who never leaves, who knows everything, and who can be queried on any aspect of your system.
You can't stop turnover. But you can make sure it no longer costs you anything in compliance.
Stop letting a departure put your compliance at risk.
Discover how MAC secures the continuity of your quality system — no matter how your teams move.