Walk into the audit knowing exactly what they'll find.
Because you put it there. Lightworks is the QMS for the people on the regulatory hook for AI/ML SaMD — every requirement, change and signature hash-chained to a 21 CFR Part 11 audit trail and one click from a submission-ready Design History File.
Free pilot for pre-submission · No procurement cycleYour job isn't paperwork.
It's defensible evidence.
You're the one who has to stand in front of a notified body, a 510(k) reviewer, or an internal exec and prove the AI you're shipping is safe, controlled, and traceable. Lightworks gives you the receipts before anyone has to ask.
Regulatory interface
ISO 13485, IEC 62304, 21 CFR Part 11, FDA PCCP guidance — pre-mapped to artefacts.
Audit clearance
Signed audit log per release. Every commit, comment, and approval, immutable and exportable.
Data quality
Drift monitors, training-data lineage, and validation reports tied to specific model versions.
Traceability
Requirements, tests and SOPs linked end-to-end — a coverage gap fails CI before it ships.
From Quality Manual to clearance, in five steps.
Set the system
Author your Quality Manual and SOPs in a clean editor. Start from ISO 13485 templates, or import what you have.
Gate the work
Every change flows through a Change Request. You approve with an MFA eSignature — nothing merges without you.
Capture the evidence
Engineering work is tied back to requirements and tests automatically. A coverage gap fails CI before it ships.
Publish and Submit the DHF PDF
Tag a release. Lightworks compiles a 300-page Design History File with audit log, traceability matrix and SBOM — ready to submit.
Question, Answer, Repeat, Clearance
The LQL console queries your QMS at any point in time — branch-aware, version-aware, SQL-style. An auditor asks what REQ-44 looked like at v1.2.0. You run a query.
Markdown that feels like Notion. Signed like a medical device.
Author your Quality Manual, SOPs, and controlled documents in a clean editor with /commands, @mentions, and inline databases. Everything is stored as plain markdown in your repo — no proprietary format, no vendor lock-in.
- · ISO 13485 templates pre-installed
- · eSignature on every controlled document
- · Version history is your git log
- · Full-text search across branches
Nothing reaches production without your signature.
Every change to a controlled artefact — an SOP, a requirement, a cleared model — opens a Change Request. Reviewers add their context. You add the signature. The system blocks the merge until you do.
- · Side-by-side diff of the controlled document
- · Required reviewers per artefact class
- · MFA eSignature with stated intent at merge
- · Automatic impact analysis on linked reqs and tests
The PDF that used to take three weeks. Compiled in seconds.
Tag a release. Lightworks bundles the SRS, the V&V reports, the traceability matrix, the SBOM, the cybersecurity documentation, the labelling and the signed audit trail into one paginated PDF — pre-flight checked, locked to the release tag, and ready to drop into a 510(k) eSTAR.
BUILD TIME 4.2s · 312 PAGES · ZERO SHAREPOINT
Speak Git. Or don't.
Quality managers think in revisions and drafts. Quality engineers think in commits and branches. Lightworks lets each person pick their own vocabulary — the underlying file, the audit trail, the regulatory artifact stay identical.
One QMS. Two languages. Zero retraining for the auditor.
Less paperwork. More control.
Stop sprinting before audits. Live in a permanent state of ready.
When your evidence is captured at the moment work happens, there is no "audit prep." Run a query, hit export, hand over the PDF. The notified body sees exactly what your team was doing yesterday.
FDA cleared 1,100+ AI/ML-enabled devices through 2024. None of the QMS tools their Quality Managers used were built for AI.
“The first audit I ran with Lightworks I didn't lose a weekend. The reviewer asked for our change history on REQ-44 and I had a signed PDF on her desk in ninety seconds. That used to be three days of archaeology.”
Per product line, not per seat. Bring everyone.
What Quality Managers ask first.
The next audit is on your terms.
Twenty minutes with our team. We'll show you what your audit trail looks like on day one — and what your DHF looks like the day you tag a release.