COMPLIANCE

Compliance work that never ends, read by agents that never stop reading.

The agents read your records, find the exceptions and show their reasoning. The decisions stay with your people.

THE PROBLEM

The evidence exists. Assembling it is the work.

The evidence for a batch, a lot or a shipment sits in the ERP, the quality system, the maintenance system, the laboratory system, document control and in paper records scanned into a folder. Someone has to open each one, line it up against the others and find what does not match. That work is manual, it repeats every batch, and it is done by the most experienced people in the plant. When the reading is done for them, their time goes to judgment.

WHAT THE AGENTS DO

Six steps, the same every time.

The agents do the reading and the cross-checking. Your reviewers do the judging.

01

Read the sources, electronic and scanned.

02

Link every record to one batch, lot or shipment identifier.

03

Compare against the approved baselines: specifications, revisions, approvals and ranges.

04

Raise each exception with its reason and its evidence.

05

Route it to a named reviewer.

06

Follow up until closure, and check that closure happened.

What the agents never do

Release, certify or disposition a batch

Close a deviation, investigation or CAPA

File anything with an authority

Write to your systems outside the transitions you approve

Send a message without a named person's approval

Contact a regulatory authority or a customer

Promote itself to a higher autonomy level

Make you compliant. Compliance decisions and accountability stay with you.

INDUSTRIES

Choose your industry

Pharmaceutical and Life Sciences

Batch record review, market document applicability, deviations and inspection readiness, read across your quality, manufacturing and packaging systems.

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Food and Beverage

Supplier certificates, allergen changeovers, preventive control records and lot traceability, assembled for your next audit.

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Nutraceutical and Dietary Supplements

Component identity, master and batch production records, and label claim support, checked against specification.

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Chemicals

Safety data sheet currency, hazard classification and customer compliance questionnaires, tracked without a spreadsheet.

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HOW IT WORKS

Every agent works as the maker. Your people stay the checker.

The rules that decide whether an exception exists are code, versioned and testable. The language model reads documents and explains findings. It does not decide. Every agent starts by suggesting only, and earns wider autonomy through its approval history and a change control you sign.

How it works →
Compliance decision rights mapFour overlapping circles for Head of Quality, Regulatory Affairs, Qualified Person, and IT and CISO, with shared decisions in each overlap and the agents at the center.Compliance decision rights mapHead of QualityQuality systemSets active rulesNames reviewersApproves level changesOwns CAPA decisionsRegulatory AffairsAuthorities and marketsOwns every filingMarket applicabilityTracks commitmentsAnswers authoritiesCommitmentsChange controlsInspection commitmentsInspection packageBatch dispositionException reviewDeviation citationsCAPA decisionsRecords integrityPart 11 recordsAudit trail reviewData for submissionsAgentsprepareRelease evidenceElectronic signaturesRecord review evidenceRelease audit entryCertifies the batchReleases or rejectsJudges open exceptionsSigns the recordQualified PersonRelease authorityGrants read accessApproves transitionsSets masking rulesKeeps the audit trailIT and CISOAccess and dataShared work needs clear decision rights.The agents read, correlate and explain. A named person decides.

Who decides

Head of QualityQuality system
  • Sets active rules
  • Names reviewers
  • Approves level changes
  • Owns CAPA decisions
Regulatory AffairsAuthorities and markets
  • Owns every filing
  • Market applicability
  • Tracks commitments
  • Answers authorities
Qualified PersonRelease authority
  • Certifies the batch
  • Releases or rejects
  • Judges open exceptions
  • Signs the record
IT and CISOAccess and data
  • Grants read access
  • Approves transitions
  • Sets masking rules
  • Keeps the audit trail

Shared decisions

CommitmentsHead of Quality and Regulatory Affairs
  • Change controls
  • Inspection commitments
  • Inspection package
Batch dispositionHead of Quality and Qualified Person
  • Exception review
  • Deviation citations
  • CAPA decisions
Records integrityRegulatory Affairs and IT and CISO
  • Part 11 records
  • Audit trail review
  • Data for submissions
Release evidenceQualified Person and IT and CISO
  • Electronic signatures
  • Record review evidence
  • Release audit entry

At the center

Agents prepare
Shared work needs clear decision rights.The agents read, correlate and explain. A named person decides.

QUALIFICATION

Who this is for

GOOD FIT

NOT A GOOD FIT

Regulated manufacturer with batch or lot records to review

Looking for a system that releases batches or closes deviations

Evidence spread across ERP, quality, maintenance and paper

Wants to replace a QMS, MES or LIMS

Review queues that grow before every release or audit

Expects compliance guaranteed by software

Quality leaders who want reasoning they can check

No named reviewer available to confirm findings

Willing to start with an export before any integration

Needs a cost figure before any working session

FAQ

Common Questions

All FAQs →

Does this replace our quality management system?

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No. It reads the quality system and the rest of the landscape and correlates them. Your systems of record do not change.

How can an AI system be validated?

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The rules that decide are deterministic, versioned and testable. The model retrieves and explains. The audit trail is append-only.

Who is accountable if something is missed?

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Your reviewer, exactly as today. The system shortens the queue and shows its reasoning for every finding.

What if our data is messy?

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That is the normal starting point. Extractions carry a confidence score, and anything below the threshold goes to a person.

We cannot give system access yet.

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Start with a spreadsheet export. No integration is needed to see the workspace running on your own data.

Can it run inside our own environment?

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Yes. Decide this before the build, not after.

What does it cost?

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It depends on your sources, volumes and hosting. We discuss it with your numbers in a working session.

Bring one batch.

Send us an export for one batch or lot. We will run the workspace on your data and walk through what it finds with your reviewer.

How many systems does your team open before it can say a batch record is complete?