Accreditation evidence, from the delivery dock to the EQA result.
LotWarden and EQAWarden are two offline applications for NATA and ISO 15189 accredited laboratories. LotWarden records what comes into the laboratory: every reagent, calibrator and control lot, checked at the door and written to the controlled logs. EQAWarden reviews how the laboratory's results perform in external quality assurance, and ranks the likely causes when one deviates. Linked by lot on one PC, they keep two of the records an assessor asks to see joined.
Two separate applications. Each does one job and runs on its own.
Neither needs the other. A laboratory can run LotWarden alone, EQAWarden alone, or both with the link switched on.
- LotWarden is goods-receiving software for accredited laboratories. It reads a scanned supplier delivery note with offline OCR and checks every lot against the pre-acceptance register.
- It writes the receipt into the laboratory's own controlled Excel logs, through Excel, after a backup. No migration and no new system of record.
- It keeps the lot's story: received, accepted, put into use, removed, and by whom, with a stock outlook from the logs' own dates.
- It builds the assessment pack for a NATA (ISO 15189) assessment or an ISO 9001 audit, each item mapped to its clause.
- EQAWarden is EQA review software for RCPAQAP chemical pathology results. It reads the myQAP survey report and scores every result against its APS.
- It applies 58 finding rules, all published, and ranks 21 possible causes with the evidence for and against each.
- It puts internal QC beside the EQA result, from Bio-Rad Unity Real Time exports.
- It suggests; people decide. The outcome is the reviewer's, signed with initials, and exported as a survey record, a cycle summary and a NATA evidence pack.
Four parts of the standard, and the record each application keeps for it.
NATA assesses medical laboratories against ISO 15189:2022. These are the clauses the two applications were built against. The laboratory's procedures remain its own; the applications keep the records those procedures produce.
| Clause | What the laboratory must show | The record, and which application keeps it |
|---|---|---|
| 6.6 Reagents and consumables | What was received, its lot, expiry and condition, and that it was accepted before use | LotWarden. The receipt in the department's log, the lot's verdict against the pre-acceptance register, the date in use, and the lot history |
| 7.3.7.2 Internal quality control | That IQC was run and reviewed | EQAWarden reads the Unity Real Time export and shows IQC beside each EQA result. It does not run or replace the IQC system |
| 7.3.7.3 External quality assessment | That EQA results were reviewed, deviations investigated and action taken | EQAWarden. The signed review record for every survey, with the score, the findings, the cause and the outcome. LotWarden adds EQA by lot to its assessment pack |
| 7.11 Data and information management | That software used for records is validated for its intended use | Both. A validation dossier per release, built from fictional fixtures and a release check that is re-run every time |
More detail: how LotWarden records reception against clause 6.6, and EQAWarden's review record and reports.
Two kinds of investigation, and the lot that connects them.
An accredited laboratory investigates at two points: when a lot arrives that has not been accepted, and when a result deviates. Each application produces the worklist for one of them.
At the door: the lot investigation worklist
LotWarden puts every new, rejected or untested lot on a ready-made worklist, worst first, each with the action required and blank columns for outcome and initials. Stock expired on arrival goes to the top with a quarantine action.
After the survey: the EQA investigation
EQAWarden tests each result and its history, names the findings with their numbers, ranks the likely causes, and offers ordered checks from its investigation playbooks. It suggests one of four outcomes: corrective action, investigate, acceptable and monitor, or acceptable.
The link: was it the lot?
With the link on, EQAWarden marks every reagent and calibrator lot change on the analyte's chart and runs a step test at each one. The reviewer sees whether results moved when the lot changed, without rebuilding the trail from the logs.
Confidential by construction: the same four properties in both.
EQAWarden reuses LotWarden's platform code, so IT reviews it once. The ten-minute checklist applies to both.
Offline, enforced
Only loopback connections are permitted, refused at socket level and logged. Neither application has an online mode, an account or a cloud copy.
No AI
LotWarden's reader is a bundled OCR engine. EQAWarden's findings come from fixed, published rules. The same input gives the same output every time.
Hash-chained audit trail
Every action carries the user, the time, the release and a SHA-256 chain value. Edit, insert or delete a line and the chain is reported broken.
One folder, encrypted at rest
Each application is a single folder on a Windows PC. No installer, services, registry writes or admin rights. Records are encrypted on the drive.
Two records kept well, not a whole quality system.
- They are not a laboratory information system and hold no patient data.
- They are not a document control, training, equipment or complaints system. Those parts of ISO 15189 remain the laboratory's own.
- LotWarden's stock outlook is advisory. It orders nothing.
- EQAWarden covers RCPAQAP chemical pathology programmes with numeric results. It does not make the decision: the reviewer does.
- Neither application is certified or accredited, and neither is affiliated with or endorsed by NATA or ISO. NATA assesses laboratories, not software. Both are built against ISO 15189:2022 and validated per release.
Questions about the two together.
What is LotWarden?
LotWarden is offline goods-receiving software for accredited laboratories. It reads scanned supplier delivery notes, checks every reagent lot against the laboratory's pre-acceptance register, writes the receipt into the laboratory's own controlled Excel logs and builds NATA (ISO 15189:2022) and ISO 9001 assessment packs. It uses no AI and never opens a network connection.
What is EQAWarden?
EQAWarden is offline software for reviewing external quality assurance results from RCPAQAP chemical pathology programmes. It scores every result against its allowable performance specification, applies 58 published rules, ranks the likely causes of a deviation with the evidence for each, and records the reviewer's signed outcome.
Do we need both?
No. They are separate applications and each runs alone. The link between them is off by default and is switched on with initials. With it on, EQAWarden knows which lot was in use when each result was analysed, and LotWarden's assessment pack gains EQA results by lot.
Do they replace our laboratory information system or quality management system?
No. LotWarden writes into the controlled workbooks the laboratory already keeps, and EQAWarden keeps its own review records. Neither holds patient data, and document control, training and equipment records stay where they are.
Does any data leave the laboratory?
No. Both applications accept loopback connections only. A socket-level guard refuses any outbound connection and logs the attempt, so an empty block log after a full day is evidence that nothing was sent.
Are they NATA accredited or ISO certified?
No, and no software is. NATA assesses laboratories. LotWarden and EQAWarden are independent products, not affiliated with or endorsed by NATA or ISO. They are built against ISO 15189:2022 and each release comes with a validation dossier the laboratory can show an assessor.
Which departments and disciplines do they cover?
LotWarden receives for Chemistry, Haematology, Serology, Microbiology and Stores, with the pre-acceptance register cross-check in Chemistry. EQAWarden covers RCPAQAP chemical pathology programmes.
One walkthrough, both applications.
We receive a delivery in LotWarden, switch the link on with initials, and open the EQA assessment that names the lot. Twenty minutes on a video call, wherever you are.