SIG RQMS-MKT-001·REV 05·Live
Audit-ready is a state,
not a sprint.
RainerQMS is the quality management system built for accredited laboratories. Documents, deviations, CAPAs, training, equipment and proficiency testing — one system, one unbroken signal of evidence.
CH·01·THE FINDING
Your quality system shouldn't be the finding.
Most labs don't fail assessments on science. They fail on the system around it — the SOP revision nobody circulated, the training record in someone's inbox, the calibration certificate in a drawer. Quality lives in binders, spreadsheets and heroics, and every audit becomes an archaeology project.
RainerQMS replaces the scramble with a system: every record controlled, every action attributed, every consequence wired to its cause.
- Finding
- Quality records distributed across 14 spreadsheets, three shared drives and one retired lab manager's memory.
- Classification
- Major nonconformity — systemic
- Recommended corrective action
- Implement a quality management system built for laboratory work.
- Due date
- Before the next assessment visit.
CH·02·THE SYSTEM
Eleven channels.
One record.
Every module reads and writes the same controlled record — so a deviation knows its instrument, a CAPA knows its finding, and a training record knows exactly which SOP revision it certifies.
Document Control
Controlled SOPs and methods with draft-to-obsolete lifecycle, e-signed approval and periodic review.
Open channelQuality Events
Deviations, OOS results and nonconforming work — captured, classified by severity, investigated.
Open channelCAPA
Root cause to effectiveness check — a corrective and preventive loop that actually closes.
Open channelChange Control
Multi-stage review with departmental impact assessments, regulatory checks and e-signed decisions.
Open channelAudit Management
Audit programs on a calendar, ISO clause-mapped checklists, findings tracked to closure.
Open channelTraining & Competency
Assignments triggered by document approvals; e-signed completions, scores and expiry tracking.
Open channelEquipment & Calibration
As-found / as-left calibrations, measurement uncertainty, due dates — and automatic events on failure.
Open channelRisk Management
A live 5×5 register scoring operational, impartiality and regulatory risk, with owned mitigations.
Open channelProficiency Testing
PT rounds and interlaboratory comparisons with automatic z-scores and En numbers.
Open channelComplaints
Client complaints from intake to investigated, answered and closed — mapped to ISO 17025 §7.9.
Open channelManagement Review
Clause 8.9 reviews with compiled inputs, agendas, minutes and action items that get done.
Open channelThe platform beneath
Workflow engine, role-based access, immutable audit trail — plus an AI assistant and MCP integrations, shared by every module.
Explore the coreCH·03·CAUSE, MEET CONSEQUENCE
The system reacts
before you have to.
In a paper system, consequences depend on somebody remembering. In RainerQMS, they're wired in. Records don't just sit near each other — they act on each other.
- A document is approved → training is assigned to its distribution list.
- A calibration fails → a quality event opens itself against the instrument.
- An audit finding is raised → a CAPA carries it to verified closure.
- A PT round scores unsatisfactory → corrective action starts the same day.
FIG. 03 — CROSS-MODULE AUTOMATION, AS SHIPPED
CH·04·EVIDENCE, NOT ANECDOTE
Signed. Sealed.
Traceable.
An assessor doesn't ask how you feel about compliance. They ask for the record. RainerQMS answers with 21 CFR Part 11 electronic signatures bound to a SHA-256 hash of the record they sign, an append-only audit trail nobody can edit — not even us — and ALCOA+ data integrity in every module.
Electronic signatures with meaning
Identity re-verified at the moment of signing; name, meaning and timestamp bound to the record hash.
Append-only audit trail
Every create, change, approval and login recorded with actor and time. No update. No delete. No exceptions.
ALCOA+ by construction
Attributable, legible, contemporaneous, original, accurate — enforced by the data model, not by policy memos.
connected modules on one controlled record
uptime SLA, with 99.95% for enterprise plans
ISO/IEC 17025 management & technical clauses, mapped end to end
of legacy enterprise QMS suites — see pricing
CH·05·SCOPE OF APPLICATION
Built for the bench,
not retrofitted from pharma.
RainerQMS is written in the language of testing and calibration laboratories — measurement uncertainty, z-scores, impartiality registers, nonconforming work. If your lab answers to an accreditation body, this is home.
TESTING LABS
Environmental, food & beverage, pharmaceutical QC, chemical, cannabis, forensic and agriculture laboratories accredited to ISO/IEC 17025.
CALIBRATION LABS
Calibration providers who live and die by traceability, reference standards, uncertainty budgets and instrument history.
CLINICAL & PUBLIC HEALTH
Medical microbiology, chemistry and pathology labs working under ISO 15189 and CLIA, from single sites to networks.
CH·06·COMMERCIALS, CONTROLLED
Priced for labs of ten,
not divisions of ten thousand.
Per user, per month, quoted for your lab. No modules sold separately, no surprise line items. Read-only seats at a reduced rate.
Starter
Small labs getting off paper
per user / month · quoted
- All 11 QMS modules
- Single site · 10 GB documents
Professional
Mid-size labs scaling their system
per user / month · quoted
- Everything in Starter
- SSO · API · up to 3 sites
Enterprise
Networks, multi-site, validation needs
multi-site & validation scoping
- Unlimited sites · IQ/OQ/PQ package
- 99.95% SLA · dedicated CSM
FINAL CLAUSE
Your next assessment is already on the calendar.
Be ready before the letter arrives. A 30-minute demo with someone who has sat on both sides of the audit table.
Approved for release