The problem
Keep the access trail behind GMP-critical systems continuous: why it breaks now
Data integrity and access-trail requirements around GMP-critical systems are already strict, and generative AI use near those systems is becoming more restricted, not less. Validated environments can't absorb ad hoc access changes without breaking their own compliance status. Rencore automates access governance so every change is enforced and logged the same way, every time.
Built for your role
What each stakeholder gets
- CISO / Security Leader. The question is not whether GMP-critical systems are monitored, it is whether the access trail behind them is complete enough to survive an inspection. Rencore keeps that trail continuous.
- IT Administrator / M365 Architect. Validated environments cannot absorb ad hoc access changes without breaking their own compliance status. Automate access governance so every change is enforced and logged the same way, every time.
- IT Manager / IT Director. Data integrity audits need access-trail evidence on demand, not reconstructed from memory and email threads. Build that evidence into daily operations.
- Business Leader / AI Champion. In DACH specifically, lead with governing the boundary generative AI cannot cross yet under draft Annex 22, not with acceleration. Everywhere else, lead with adopting AI without opening a new access-trail gap.
Why Rencore
Proof points
- 13x Named by Gartner as the third-party governance alternative
- 4.8/5 Rating on G2
- 157% Year-one ROI reported by customers
- 100%+ ARR growth, three years running
Data integrity and access-trail requirements around GMP-critical systems are already strict, and generative AI use near those systems is becoming more restricted, not less. Rencore keeps the evidence ready before the inspection asks.
Trusted by security, IT, and platform leaders
Security, IT, and platform leaders use Rencore to see their Microsoft estate, cut cost and risk, and roll out Copilot and agents on a governed foundation.
Where this hits hardest
UK & Ireland
GMP data integrity expectations apply regardless of which national regulator is auditing. The governance argument is the access trail itself: who touched a GMP-critical document, and can that be proven without a manual reconstruction.
Nordics & Benelux
EU GMP Annex 11 already sets expectations for computerized systems and data integrity in manufacturing. That existing obligation, not a future one, is the argument for continuous access-trail evidence today.
DACH
Draft Annex 22 would bar generative AI from touching critical GMP systems entirely — still a draft, so it's the direction of travel, not settled law. This is the one region where the AI message flips: lead with governing the boundary AI cannot cross yet, not with accelerating adoption.
North America
FDA expectations for electronic records and access trails under 21 CFR Part 11 mean GxP manufacturers need to prove who accessed a validated system and when. Reported access-trail gaps in the sector make the cost of not having that proof concrete.

