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Add-on module
Non-conformances, incidents, CAPA, audits, risks, field safety notices and management review, in one place, fed by the QC, EQA, device and competency records the platform already holds. Built around ISO 15189:2022 and its point-of-care annex.
The registers
Numbered NC-YYYY-NNNN, with a state machine and close gates so an NC cannot be closed with an empty root cause. Raised by hand or automatically: QC rejections (major), trend rules (minor), EQA failures (major). Five-whys and fishbone helpers on the record.
Priority and SLA by severity, an MHRA reportability suggestion, a duty-of-candour prompt at moderate harm and above, a Datix-style report and an MHRA export. Wrong-patient results raise one automatically.
Corrective and preventive actions raised from an NC, owned, dated and closed out, with the NC linked back.
Template to checklist to completion to findings to NCs to sign-off. Included: ISO 15189:2022 POCT-focused (45 items including Annex A), MHRA point-of-care 2021, site walk-round, IQC/EQA review. Equipment items link straight to service, cleaning, custody and temperature records.
The NHS 5x5 matrix, scored and reviewed, with a printable heat map.
Log the notice, match it to your lots with patterns such as AB* or ALL, and see the affected devices, controls and consumables from the live stock and device registers.
A pack assembled from IQC, EQA, NCs, CAPAs, incidents, complaints, audits, risks, FSNs, competency, controlled documents and equipment, with a readiness check before the meeting. Each section reports whether its data was available.
NC, incident, audit, risk register, FSN and management-review reports, printed to PDF from the record.
An attention list of what is overdue, and a shared notes timeline across NCs, incidents and audits.
Where the evidence comes from
A quality system that lives in a separate tool has to be fed by hand. This one reads the operational record directly.
| Assessor asks for | Where Catenix gets it | Kept by |
|---|---|---|
| IQC performance and monthly review | Control runs captured from analysers, rules fired, reviews and sign-offs | Quality control |
| EQA participation and investigations | Scheme returns, z-scores, investigations, annual summary | EQA |
| Equipment records | Service, cleaning, downtime, custody, temperature, firmware, reagents in use | Device operations |
| Staff competence | Certification per operator per device with expiry | Operators |
| Verification of methods | Signed verification packs and analyses | Statistics Workbench |
| Traceability and recalls | Lot usage windows, results per lot, recall impact | Traceability |
| Who did what, when | Hash-chained audit log with verification and extracts | Audit trail |
A non-conformance, end to end
A QC rejection rule fires. The scan opens a major NC with the run as its source, once, however many times the scan runs.
Root cause with the five-whys or fishbone helper, classification, impact. The close gate will not let an empty investigation through.
A CAPA is created from the NC, owned and dated. Overdue CAPAs and NCs appear in the Action Centre with a link straight to the record.
The NC, its CAPA and the QC run appear in the next management-review pack automatically, and the audit trail holds every step in the name of the person who took it.
A clear boundary
Catenix is connectivity, workflow, record-keeping and data display. It does not interpret results, calculate clinical values, classify or flag results clinically, or provide clinical decision support. Statistics describe methods, processes and datasets, never a patient. Any reference range or note shown is customer-authored content Catenix displays.
Questions, answered
For point-of-care testing, Catenix covers the registers an assessor asks to see: non-conformances, incidents, CAPA, internal audits with findings, the risk register, field safety notices and management review, each with a printable report. Many services keep a laboratory-wide QMS for the main lab and use Catenix for the POCT estate, because the POCT records are generated by the same system that runs the bench.
By hand from anywhere in the platform, or automatically: QC rejection rules open a major NC, trend rules a minor one, and EQA failures a major one. The scans are idempotent, so the same failure never produces two NCs. A device temperature excursion left unacknowledged for 24 hours, or a planned service more than 7 days overdue, can also become an NC without anyone pressing a button.
An ISO 15189:2022 checklist focused on POCT with 45 items including Annex A, an MHRA point-of-care checklist based on the 2021 guidance, a site walk-round and an IQC/EQA review. Each audit copies its template so the checklist can be scored and findings raised as NCs.
IQC performance, EQA, non-conformances, CAPAs, incidents, complaints, audits, risks, field safety notices, competency, controlled documents and equipment, pulled from the live data. Each section says honestly whether the data was available, so the pack never presents an empty table as a clean result.
Yes. Quality Management is a marketplace add-on at a flat monthly price per site, switched on when you want it. QC, the audit trail and operator competency are part of the core platform.
We will show how each finding would have been raised, tracked and evidenced in Catenix, on a live tenant.