How LMOS works

From upload to in force

1. Upload. Any governing document: SOPs, training manuals, good-practice documents, policies, reference material such as device instructions and package inserts, regulatory and accreditation standards, and memos. Each class is versioned and cited separately.
2. Verify. Text extracted from scans or legacy files is confirmed by a person before it becomes the source of truth. Extraction errors read as plausible, so a human check is mandatory.
3. Classify and route. LMOS works out what the document is and which artifacts it affects. A training manual feeds tutorials, a good-practice document feeds competency criteria, an SOP feeds step-by-step guidance and the knowledge base.
4. Screen. The document is checked against the regulatory corpus. Conflicts are cited to the section and block go-live.
5. Approve. People sign, with two factors, through the same chain as the SOPs themselves.
6. Regenerate and acknowledge. Dependent artifacts regenerate and wait for sign-off. The right staff receive the change and acknowledge it.

The grounding contract

These rules are enforced in the software, not left to how a prompt is worded.

1. Answers come only from approved, retrieved passages. The model's background knowledge is not used.
2. Refusal is a designed outcome. If the documents do not cover a question, LMOS says so and escalates.
3. Every answer carries a citation: SOP number, revision and section. No citation, no answer.
4. Procedure steps are returned as source text, not paraphrase.
5. Below a confidence threshold, LMOS declines. It is tuned toward false refusals rather than false answers.
6. Every answer is tied to the version retrieved, so it can never quietly point to a superseded procedure.
7. When anything is uncertain or sources conflict, it escalates to a person. It never produces a best guess.

Authority, memos and conflicts

When documents disagree, the order is fixed: regulatory and accreditation standards first, then SOPs, good-practice documents, training manuals and reference material. Standards always win, and no upload order can change that. A memo is a temporary, point-specific override that sits just below the standards. Only the affected steps change, they are labeled as modified by the memo, and document control is prompted to reconcile it into the SOP. LMOS never silently picks a side: it flags the conflict and cites both documents.

Regulatory screening

Public federal text is the foundation: 21 CFR 606, 610, 640, 600, 607 and Part 11; 42 CFR 493 (CLIA) and 482; FDA's guidance on validating blood establishment computer software; and OSHA's bloodborne pathogens standard. Each regulation is split into sections, so every flag cites a section, never a whole part. The stricter requirement wins. LMOS records the edition date and a fingerprint of each source; when one changes, it diffs the affected sections, re-screens every approved SOP that cites them, and routes the result to people.

Human sign-off, by design

Introducing a governing document takes two-factor authentication and a double signature, so a single user cannot do it alone. Generated guides, tutorials and tests are held for medical director or SBB approval. Acknowledgments start as not yet acknowledged, never as accepted. Every signature shows who signed, when, and what it meant, and is designed to support the requirements of 21 CFR Part 11.

Training and competency

Tutorials, scored simulations and knowledge tests are generated from the approved source and regenerate with it. Competency is built on the six CLIA procedures: direct observation of test performance, monitoring of result recording and reporting, review of worksheets and QC records, direct observation of instrument maintenance, test performance on previously analyzed or proficiency-testing samples, and problem solving. LMOS generates the observation and record-review checklists from your SOP and device instructions. A supervisor signs. LMOS stores the attestation, never the worksheet or the result. A failed assessment routes the matching retraining.

Quality operations and inspection

Deviations are raised against the exact step that failed. CAPAs are tracked from initiation to verified closure with trends. Proficiency-testing failures open linked deviation, CAPA and competency review. Vendor and equipment qualifications, renewals and maintenance alert before they lapse. Internal audits route findings to CAPA, and changes to process, equipment or software need signed approval. For inspections, LMOS links evidence from the approved store to the checklists your lab licenses, and an inspector view reconstructs the history of any record.

Autonomous operations, designed to

LMOS is designed so that agents prepare recurring compliance work and people sign. No agent signs, certifies, attests, files or pays on anyone's behalf. Each recurring duty has a declared limit, and a weekly report shows the human minutes the work consumed.

Where it runs

The on-premise tier runs on the laboratory's hardware, isolated from the public internet, with only controlled, authenticated integration points, and with models installed rather than streamed. The cloud tier is hosted at lmos.bio, with each laboratory its own isolated tenant. The same codebase serves both.