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Solution

Keep the access trail behind GMP-critical systems continuous

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.

  • With Rencore's scalable automation solutions, organizations can not only meet current challenges but also prepare themselves for future technological advancements.
    Case Study
    Philipp Widmer Philipp Widmer Head of Platform Services Universitätsspital Basel
  • 26% vs 3%

    Organizations that govern Microsoft 365 well realize significant Copilot value 26% of the time, versus 3% for those that do not.

    Gartner, 2025 Microsoft 365 Copilot Survey
  • As we continue to expand our cloud capabilities, the foundation laid by Rencore Governance will undoubtedly play a crucial role in ensuring that each step forward is taken with confidence, security, and compliance in mind.
    Case Study
    Claude Bisdorff Claude Bisdorff Head of IT Systems Ville de Luxembourg
  • 116%

    ROI from Microsoft 365 Copilot once the program is adopted and governed, in Forrester’s Total Economic Impact study.

    Forrester Total Economic Impact
  • I currently estimate that we save around €80k per year by freeing up our IT admin team to do the work that counts.
    Case Study
    Undisclosed Undisclosed Former Lead O365 Competence Center Royal BAM
  • 71%

    of enterprises name security and governance among their top challenges to deploying Microsoft 365 Copilot.

    Gartner
  • Rencore's centralized governance tool excelled at ensuring secure data in Microsoft 365 and minimizing the risk of unauthorized access.
    Case Study
    Greg Bowles Greg Bowles IT Operations Manager Specialist Risk Group
  • 150,000+

    AI agents in use at the average Fortune 500 company by 2028. Agent sprawl is the next sprawl.

    Gartner
  • With Rencore Governance we are able to reduce manual governance activities, improve our service quality and generate valuable insights across our Microsoft service stack.
    Undisclosed Undisclosed Head of AI & Process Automation Wacker Chemie AG
FAQ

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.

Keep the access trail behind GMP-critical systems continuous

Rencore is the governance layer that lets GxP manufacturers adopt Microsoft 365, Power Platform, and AI at speed, without losing control of who can see, share, or automate what.