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Software validation for clause 7.11

Clause 7.11.2 expects software used for laboratory activities to be validated before use and again after changes. AccreditBook ships the evidence for that with every release, so your validation record is a review and a signature rather than a project.

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What the pack contains

DocumentWhat it is
Requirements specificationEvery function the software performs, as a numbered requirement. For example, REQ-EQ-003: the next calibration due date is the last calibration date plus the interval in months, unless a due date from the provider's certificate is recorded. Each requirement names the tests that cover it.
Test evidenceFor the release: every automated test, the requirements it covers, its result, the date it ran and the exact version of the code it ran against.
Traceability matrixRequirement to test, in one table. A release cannot be published while any requirement has no passing test.
Release notesWhat changed in the release and which requirements each change touched, so you can judge whether the change affects how your lab uses the software.
Change control procedureHow a change is proposed, reviewed, tested, released and, if needed, rolled back.
Infrastructure and backup statementHosting region, encryption, backup schedule and the log of quarterly restore drills.
Validation coverA short template your lab completes: intended use, the version validated, any checks you ran with your own data, who reviewed it, and the signature.

How it is produced

The pack is generated from the same test run that gates the release, not written up afterwards. On every tagged release:

  1. The full test suite runs: unit tests of calculations such as due dates and due status, database tests including the tenant-isolation suite, and end-to-end tests that drive the application in a browser through tasks such as recording a calibration with a certificate and exporting the assessor pack.
  2. Each test carries the requirement numbers it verifies. The test results and those numbers are collected into the test evidence document and the traceability matrix.
  3. If any requirement has no passing test, the release stops.
  4. The pack is published for that version and added to the validation/ folder of your assessor pack, so the assessor finds it next to the records it supports.

What remains your lab's responsibility

The pack shows that the software does what its requirements say. Your lab still decides whether it is fit for your intended use: which modules you rely on, whether any calculation feeds results you report, and what you check with your own data. The cover template is where that judgement is recorded and signed. After an update, read the release notes, decide whether the change touches your intended use, and sign a new cover if it does.

AccreditBook holds quality records. It does not calculate measurement results or uncertainties, so the validation burden is that of a records system rather than of a calculation tool.

Where to find it

Each version's pack is published inside the application and included in every assessor pack. The changelog lists releases. For a sample before you sign up, write to support@accreditbook.com. See also Clause 7.11: Control of data and information management.