Software and Spreadsheet Validation Record

Purpose

Records the validation of software, spreadsheets and configured system functions before use and after change, per clause 7.11.2 and SOP-19: the system and version, its classification, the test cases with expected and actual results, the controls applied (protection, version, access) and the approval for use.

What it covers

• 1. Description and classification
• 2. Test cases
• 3. Controls
• 4. Conclusion
• Authorisation

How to complete it

1. 1.Complete Section 1 to identify the system, version, function and classification; attach the specification of what it must do.
2. 2.Design test cases in Section 2 covering normal values, boundary values, invalid inputs, and worked examples with independently known answers (for uncertainty tools use the M3003 examples); include interface tests (data import / export) where applicable.
3. 3.Record actual results, pass / fail, and any restrictions. For spreadsheets confirm cell protection, input / calculation distinction, version on sheet, read-only storage.
4. 4.The system owner approves release; record the change control reference for re-validations.

Before you use it

• Replace every square-bracket token, starting with [LABORATORY NAME], [ADDRESS] and [EFFECTIVE DATE]. The full token list is in GD-01 Read Me First.
• Have the content technically reviewed against how your laboratory actually works, then approved by the responsible manager before it becomes a controlled document.
• Update the Word fields after editing so the table of contents and page numbers are correct: select all, then press F9.
• Record the document in your own document register and set its review date.

Related documents

• QM-01

  Quality Manual

  Top-level description of the management system against every clause of ISO/IEC 17025:2017.

• SOP-19

  Control of Data and Information Management

  Validation, security, backup, integrity and change control of laboratory information systems and spreadsheets.

• CHK-01

  ISO/IEC 17025:2017 Gap Analysis and Self-Assessment

  Clause-by-clause self-assessment with evidence, gap and action columns.

• FRM-01

  Master Document Register

  Register of every controlled internal and external document with revision, status and distribution.

• FRM-02

  Document Change Request

  Request, impact assessment and approval of a change to a controlled document.

• FRM-03

  Records Retention Schedule and Disposal Log

  Retention periods by record type and a log of authorised disposals.

• FRM-04

  Internal Audit Programme and Audit Plan

  Annual audit programme covering every clause and activity, plus the plan for a single audit.

• FRM-05

  Internal Audit Checklist

  Clause-by-clause question set with evidence and finding columns for auditing against ISO/IEC 17025.