The reagent and EQA evidence for a NATA assessment, built from records you already keep.
LotWarden and EQAWarden are offline software that prepares two parts of a NATA assessment against ISO 15189:2022: the reagent and consumable records under clause 6.6, and the external quality assurance review under clause 7.3.7.3. LotWarden builds an assessment pack from the receiving logs in about a minute. EQAWarden exports the signed review of every EQA survey. Neither changes a record to do it.
An assessor's questions, and the record that answers each one.
An assessment follows the record, not the software. These are questions a laboratory should expect on reagents and on EQA, with where the answer is kept.
| The question | The record that answers it | Where it comes from |
|---|---|---|
| What arrived, and in what condition? | Date, lot, expiry, quantity, supplier, delivery-note number and condition on receipt, with the receiver's initials | The department's own log, written by LotWarden at receipt (6.6.2, 6.6.7) |
| Was the lot accepted before it was used? | The lot's verdict against the pre-acceptance register on the day it arrived, and its Date in Use | LotWarden's lot check workbook and the log (6.6.3, 6.6.4) |
| What happens to expired stock? | Expired on arrival is quarantined first on the worklist; expired on the shelf is listed for removal and the removal is logged | LotWarden's investigation worklist and stock outlook (6.6.7) |
| Who made this entry, and can it be altered? | The initials of the person, required at every receipt and sign-off, with the Windows account, time, release and a SHA-256 chain value for every action | The hash-chained audit log in both applications |
| Is the software validated? | A validation dossier for the release in use, matched to the executable's hash | Issued with every build (7.11) |
| How are EQA results reviewed? | Every result scored, each finding with its rule and numbers, the cause, the outcome and the reviewer's initials | EQAWarden's survey record (7.3.7.3) |
| What was done about the result that failed? | The investigation, the cause concluded and the corrective action taken | EQAWarden's cycle summary and evidence pack (7.3.7.3) |
Choose the visit and the dates. Two files come out.
In LotWarden, choose NATA assessment (ISO 15189) or ISO 9001 audit, set the period, enter your initials and build the pack. Nothing in the logs changes.
A presentation
The key charts and tables for the period: receipts, lots received, lots put into use and audit records, ready to open at the start of the visit.
A workbook of every record
Every row behind the presentation. Rows to check are coloured, with the reason in the first column, so nothing is found for the first time in front of the assessor.
A checklist by clause
Each item is marked In order, Check, Partly covered or Bring separately, with its ISO 15189 or ISO 9001 clause. The pack says plainly what it cannot show.
More on the pack: Assessment pack. More on the clauses: Standards alignment.
Three reports from EQAWarden, written for an assessor.
EQAWarden reviews RCPAQAP chemical pathology surveys. Each report is exported as a workbook, a web page and a Word document.
Survey record
One survey: every result, its score against the allowable performance specification, the lots in use, the internal QC status, and the reviewer's outcome, cause, conclusion and initials.
Cycle summary
Performance across the cycle, reviews open and closed, days to review and the corrective actions taken.
NATA evidence pack
The records behind the two, gathered for the visit. With the link on, LotWarden's own pack gains an EQA by lot sheet and a checklist item under 7.3.7.3.
Two clauses out of many. The rest of the assessment is still yours.
- Procedures, document control, staff competence, equipment, method validation and complaints are outside both applications.
- Supplier evaluation criteria and approvals are the laboratory's. LotWarden supplies each supplier's last 12 months of deliveries as the evidence.
- Acceptance criteria for a new lot are set by the laboratory. LotWarden records the verdict; it does not make it.
- EQAWarden suggests an outcome. The reviewer decides and signs.
- Neither application is accredited, and using them does not confer accreditation. NATA assesses laboratories, not software, and LotWarden and EQAWarden are not affiliated with or endorsed by NATA or ISO.
Questions about preparing for an assessment.
Is there software that prepares a laboratory for a NATA assessment?
No single product prepares the whole assessment. LotWarden and EQAWarden prepare two parts of it for a medical laboratory assessed against ISO 15189:2022: the reagent and consumable records under clause 6.6, and the review of external quality assurance results under clause 7.3.7.3. Document control, competence and equipment records need the laboratory's other systems.
Does NATA approve or accredit software?
No. NATA accredits laboratories against a standard. It does not approve, certify or endorse software, and LotWarden and EQAWarden are independent products with no affiliation to NATA or ISO. What an assessor looks at is the laboratory's records and whether the software that keeps them is validated for its intended use.
What does the LotWarden assessment pack contain?
A presentation of the key charts and tables for the period, and a workbook of every record behind it. A checklist marks each item In order, Check, Partly covered or Bring separately, with its ISO 15189 or ISO 9001 clause. It is built from the receiving logs without changing them.
How long does the pack take to build?
About a minute. Choose the visit and the dates, enter your initials and build it. The time that matters is before the visit: checking the rows the pack colours, and gathering the items it marks Bring separately.
Does it cover an ISO 9001 audit as well?
LotWarden's pack can be built for an ISO 9001:2015 audit, with each item mapped to its ISO 9001 clause. EQAWarden's reports are written for ISO 15189.
See the pack built on a demo year.
Twenty minutes on a video call. We build the assessment pack and open the EQA evidence, on fictional data, with the network guard on.