Eleven modules that behave like one, because they are one: a single controlled record, a shared workflow engine, and an audit trail under everything. Numbered like channels on an instrument, because that's how you'll read them.
The single source of truth, with a revision history to prove it.
SOPs, test methods, work instructions, policies and forms move through a controlled lifecycle — draft, review, e-signed approval, effective, obsolete. Everyone reads the current revision because there is no other place to look.
Full version history with side-by-side revision context
Approval signatures cryptographically bound to the document hash
Distribution lists that drive read-and-understood training
Periodic review scheduling — "due for review" finds you first
When something goes wrong, the record starts itself.
Deviations, out-of-spec results, nonconforming work, near-misses — captured in minutes with severity and priority classification, routed to investigation, and escalated to CAPA when the risk demands it.
Critical / major / minor severity with risk-based classification
Corrective action that closes the loop — and proves it stayed closed.
Six states from open to closed, and no shortcuts between them: investigation, root cause, action plan, implementation, then an effectiveness check before anyone gets to sign the closure.
Sourced from events, audit findings, complaints or PT results
Action items with owners, due dates and attached evidence
Structured root-cause capture with required fields — no blank "operator error"
The most workflow-heavy thing a lab does, made orderly: departmental impact assessments, elemental and regulatory review, quality decision, customer notification — each stage assigned, tracked and e-signed.
Multi-stage pipeline with assignment-aware steps — only the owner can complete
Per-department impact assessments collected in parallel
Extension requests with justification, not silent slippage
Full decision trail: who reviewed, what they said, when they signed
Run internal audits like the assessor is already here.
A full audit program on a calendar: reusable checklists mapped to ISO clauses, execution with evidence capture, findings classified from observation to major nonconformity — each one traceable to its corrective action.
Annual programs with scheduling and auditor assignment
Checklists with clause-mapped questions — 17025, 15189, 9001
Findings with evidence, auditee responses and due dates
Competence you can point to, person by person, method by method.
Courses, document read-and-understood, classroom sessions — assigned automatically when documents go effective, completed with score and e-signature, and tracked to expiry so recertification never surprises anyone.
Auto-assignment from document distribution lists
Pass/fail scoring with e-signed completion records
Certification expiry, recurrence and overdue tracking
A competency matrix your assessor can read at a glance
Every instrument, its history, and the uncertainty that comes with it.
A living instrument register: calibration and preventive maintenance on schedule, as-found / as-left readings, reference standards, measurement uncertainty and certificates — with a quality event opened automatically the moment a calibration fails.
Full lifecycle: commissioning to decommissioning
Calibration records with standards used and uncertainty
Due-date horizon: what's due this week, this month, next
Failed calibration → automatic quality event, no human relay
Risk-based thinking, with an actual register behind it.
Operational, impartiality, financial, regulatory and safety risks scored on a live 5×5 matrix — severity times likelihood, owners and review dates attached, mitigations tracked until the score actually moves.
5×5 heat map with drill-down to each risk
The ISO 17025 impartiality register, first-class
Mitigation plans with owners and review dates
Residual-risk tracking: before and after, side by side
The math your accreditation depends on, done for you.
Manage PT programs and rounds across providers and schemes. Enter the reported and reference values; RainerQMS computes z-scores and En numbers, flags the unsatisfactory ones, and routes them straight into corrective action.
Programs by provider, scheme, parameter and frequency
Automatic z-score and En evaluation with pass/warn/fail
Program statistics across rounds and analytes
Unsatisfactory result → CAPA with the round attached
Every complaint answered, every answer on the record.
Intake from any channel, categorized and assigned to an investigator. Root cause recorded, response sent, resolution documented — the full ISO 17025 §7.9 process without a single orphaned email thread.
The §8.9 meeting, with its inputs already compiled.
Schedule the review, and the agenda builds itself from the system: audit results, CAPA status, PT performance, complaints, risk movements. Record attendees, minutes and outcomes; assign actions that survive the meeting.
Standing agenda mapped to ISO 17025 §8.9 inputs
Attendees, minutes and decisions in one record
Action items with owners, due dates and completion
Everything above runs on a shared substrate. It's why eleven modules feel like one product — and why your auditors only need to learn one trail.
Workflow engine
Configurable approval state machines drive documents, CAPAs, changes and reviews — your process, encoded, enforced.
Role-based access
Granular permissions per product, module and action. Analysts record; reviewers review; approvers approve. Nobody else can.
Immutable audit trail
Append-only, under every module: each entry carries actor, action, resource and time. No update. No delete. No exceptions.
Strict tenant separation
Your lab's records are isolated from every other customer's at every layer of the platform. Read the trust center for the commitments.
Notifications that escalate
Due, overdue, escalated — email today, with templates and per-user preferences. Nothing expires quietly.
API & integrations
REST API on Professional and Enterprise plans; SSO via OIDC; LIMS and ERP connectors on the roadmap, in the open.
AI assistant, on the record
Ask your quality system a question — open CAPAs, overdue training, audit readiness — and get answers grounded in your own records. The assistant does the digging; a human keeps every judgment.
MCP for AI tools
RainerQMS speaks the Model Context Protocol, so approved AI tools can read and act on QMS records — under the same roles, permissions and audit trail as any user.
SEEN ENOUGH?
See it with your lab's own workflows.
A 30-minute walkthrough, mapped to the standard you're accredited to.