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The compliance kernel

Compliance by construction.

Other eQMS tools sit a checklist beside the work and trust your team to follow it, so the gap surfaces at the audit, when it is a finding. The kernel makes the non-compliant path impossible to take: not trained on the current revision, and the run will not start. Your people stay inspection-ready by doing their jobs, not by remembering the rules.

Built to adapt to your regulatory regime: 21 CFR Part 11 · ISO 17025 · ISO 13485 · ISO 9001 · GxP

Compliance by design

The wrong path is not blocked. It does not exist.

Everywhere else, compliance is a tax your team pays daily and a scramble before every inspection. Here it is a property of the data: the only path left open is the compliant one. So you stop policing, and the slip that would have cost you never gets made.

Verify result · R-8901
Requested by Sam Okafor
PermissionGranted
Training · SOP-114 rev 4Expired 12 Jun
Action unavailable. Retrain on the current revision to continue.
The slip that becomes a finding elsewhere cannot be made here
  • The deviation never happens

    Other systems trust the analyst and catch the slip at review. Here an action without the right clearance, current training, and signature cannot execute, so the finding never gets made.

  • Stop chasing expired training

    Elsewhere a lapsed qualification surfaces when the auditor finds it. Here the lapsed action simply stops working. Verification fails before a finding can, and competency polices itself.

  • Validate signing once, trust it everywhere

    Bolt-on suites sign each module differently, every one its own validation. Here one signature path covers every record, locks it, and carries who and why. One thing to qualify, not a dozen.

  • Inspection prep, from weeks to a read

    Reconstructing who-changed-what is the pre-audit scramble everywhere else. Here it is already written and unrewritable: who, what, when on every change. Audit day is a five-minute read.

  • Enter a new market without re-buying

    A new standard usually means a new tool or a long config project. Here you set the approval chain per organization, and the same core runs Part 11 in one lab and ISO 13485 in the next.

  • Add clients without adding risk

    Contract labs run a silo per client. Here every record is sealed to its organization on one deployment, so you scale clients without scaling exposure.

0
uncleared actions reach your data
Hours
to be inspection-ready, not weeks
Every regime
on one product, no forking
100%
21 CFR Part 11 clauses addressed
Built on the kernel

The same gate powers what comes next.

Because compliance lives in one place, new capabilities inherit it for free. No bolt-ons, no second source of truth.

The kernel also satisfies the standards an auditor checks. See Compliance & security.

Try to cut a corner.

Verify a result you are not cleared for in the live demo, and watch the system stop you, with the reason. The slip that becomes a finding everywhere else cannot be made here.