QMS & Regulatory Compliance
Check the work against your procedures, and your procedures against the rules
Litewave reads your SOPs, work instructions, quality manual, validation documents and regulatory filings, checks what was actually executed against what they require, and checks the procedures themselves against the regulations your site is held to. Gaps come back with the clause cited on one side and your own text on the other.
The batch record is one document in a system of thousands
Executed records are checked against procedures. The procedures themselves get checked at audit, or when a regulation moves.
A quality system is a large body of controlled text: SOPs, work instructions, the quality manual, specifications, validation protocols, training curricula, quality agreements and the commitments made in your regulatory filings. All of it is meant to agree with itself, with what the floor actually does, and with the regulations your site is inspected against.
Keeping that agreement is manual work spread thin. A method changes in a filing and three SOPs should follow. A regulation is revised and someone has to work out which of four hundred procedures it touches. A deviation is closed against a procedure that was superseded two revisions ago. None of this is difficult to judge, and all of it is difficult to find, which is why it tends to surface during an audit rather than before one.
Litewave reads the whole corpus rather than a document at a time, so the comparison stops depending on who remembers what.
How it works
Your controlled documents and your executed records go in. Cited gaps come out, in both directions.
- SOPs, work instructions and the quality manual, at their effective revisions
- Specifications, validation protocols and reports, and quality agreements
- QMS records: deviations, CAPA, change control, complaints, training
- Executed batch records and the supporting production and laboratory documentation
- Regulatory filings and the commitments made in them
- The regulations, standards and pharmacopoeias your site is held to
- Checks what was executed against what the governing procedure actually requires, at the revision that was effective on the day
- Checks procedures against each other, and against the commitments in your filings
- Checks the quality system against external requirements clause by clause
- Cites both sides of every gap, the external clause and your own text
- A gap register ranked by regulatory risk, each item traceable to a source
- The list of documents affected by a regulation change or a filing commitment
- Contradictions and orphan references across the document set
- Evidence you can hand an auditor, assembled rather than reconstructed
What Litewave checks
Execution against procedure
- The executed record follows the SOP and work instruction that were effective at the time, not a later revision
- Steps, sequences, limits and hold times in the record match the procedure that governs them
- Required training was in date for the people who signed, for the operation they signed for
- Deviations, CAPAs and change controls reference procedures that were current when they were raised
- Quality agreement obligations are met by what the site and its partners actually recorded
The document set against itself
- Procedures that contradict each other on the same operation, limit or responsibility
- References to superseded revisions, withdrawn documents and forms that no longer exist
- Specifications and methods in SOPs that disagree with the filed method or specification
- Commitments made in regulatory filings with no procedure behind them
- Documents overdue for periodic review, and revisions that never propagated to dependent documents
The quality system against external requirements
- US cGMP under 21 CFR Parts 210 and 211, Part 11 for records and signatures, and Part 111 where it applies
- EudraLex Volume 4 and its annexes, and UK GMP as enforced by the MHRA
- The PIC/S GMP Guide and WHO GMP where your site is inspected against them
- ICH Q7, Q9(R1), Q10, Q12 and the analytical guidelines
- USP, Ph. Eur. and other pharmacopoeial monograph and general chapter requirements
- Gaps returned with the external clause and the governing internal document side by side, or with the absence recorded where there is no internal document at all
Keeping up with change
- New and revised regulations and guidance mapped to the procedures they touch
- Impact assessments drafted for change control, with the affected document list attached
- Pharmacopoeial monograph revisions traced to the specifications and methods that cite them
- A standing gap register rather than a point-in-time audit report
Where it stops, deliberately
Litewave finds and cites the gap. Deciding what it means, and what to do, stays with your quality unit.
A regulatory gap is a judgement with consequences: it can trigger a change control, a retrospective assessment, a notification, or nothing at all. Litewave does not make that call, and it does not silently rewrite a procedure. It produces the finding, the external clause, your own text, and the affected documents, so the assessment your quality unit records is faster to reach and easier to defend.
Everything it reports is cited. Where the corpus does not answer a question, it says the corpus does not answer it, which on a regulatory gap analysis is frequently the finding itself.
Questions we get asked
Does this replace our internal audit programme?
No. It runs continuously underneath it. Internal audit samples deliberately, on a schedule, with trained auditors making judgements. Litewave reads the whole document set every time it runs, so the audit starts from a current gap register rather than spending its first days assembling one.
How do you keep up with regulation changes?
The regulation set is maintained as content, versioned and dated like any other controlled input, and a change to it re-runs against your document corpus. You see which procedures the change touches before you decide what to do about it.
Will it rewrite our SOPs?
Only if you ask it to draft, and a draft is a draft. Litewave can propose revised text with the driving requirement cited, but the document goes through your own change control, review and approval like any other revision. Nothing enters your document management system on its own.
Our SOPs are Word files in a document management system, some scanned.
That is the normal starting state. Litewave reads the corpus where it sits, including scans, and works at the effective revision, so the comparison is against what was actually in force rather than against whatever the newest copy happens to say.
Related
Built for validated environments
Your data stays where your auditors expect it
Deploy in your environment
Your cloud, your data center, on the plant floor, or fully air-gapped. The same agents run identically in all four, because the models are open-source and served inside your perimeter, so inference never leaves it.
Your data never trains our models
Documents are never sent to third-party AI providers, and they never train a model that any other customer touches. Where a model does adapt to your site, the handwriting engine learning your operators, that loop is closed inside your deployment and what it learns stays yours.
21 CFR Part 11
Electronic records, electronic signatures and complete audit trails on every action, built to ALCOA+ data integrity principles.
EU GMP Annex 11, and building for what is next
Meets the currently effective Annex 11 expectations for computerised systems. We are building against the draft revised Annex 11 and the draft Annex 22 on AI while both remain in consultation, so nothing here is claimed as compliance with a standard that is not yet in force.
Validated like the computerised system it is
A risk-based validation package written to GAMP 5 second edition and Annex 15 expectations: specifications and traceability matrix, IQ, OQ and PQ protocols with executed evidence, and a supplier assessment pack, so your quality unit can qualify Litewave under its own CSV or CSA procedure.
AI governance you can inspect
Context of use, model versions, performance monitoring and change control are documented against the EMA and FDA guiding principles of good AI practice in drug development, so the model sits inside your quality system rather than beside it.
Evidence on every flag
Every extraction, check and recommendation links back to its source page. Nothing asserted is unverifiable.
Human in the loop by design
Agents propose, qualified people approve. Litewave never dispositions a batch on its own.
See it run on one of your own records
Bring something real. We will show you what Litewave finds in it and what it cites as evidence.