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Procedure · SOP-19

Control of Data and Information Management

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

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Purpose

To define how the Laboratory validates, protects, backs up, maintains and controls changes to the information systems, software, spreadsheets and data used to collect, process, record, report, store and retrieve calibration data, so that data integrity, confidentiality and availability are assured.

What is inside

10 sections, about 4 pages when printed.

  1. 1. Purpose
  2. 2. Scope
  3. 3. References
  4. 4. Definitions
  5. 5. Responsibilities
  6. 6. Procedure
  7. Records generated by this procedure
  8. Monitoring and performance indicators
  9. Assessment readiness notes
  10. Related documents

Records it generates

Applying this procedure produces the following records, which are the evidence an assessor samples.

  • –System inventory and classification
  • –Validation records
  • –Change requests, impact assessments and re-validation
  • –Backup logs and restoration tests
  • –Access rights reviews
  • –Incident log

What an assessor looks for

The document closes with these points, so you can check your own practice before someone else does.

  • –Asking for the validation evidence for the spreadsheet used to calculate a sampled certificate, including the test cases.
  • –Checking cell protection and version of the spreadsheet actually on the engineer's PC against the controlled version.
  • –Confirming that a departed employee's accounts were removed.
  • –Asking when restoration was last tested and seeing the record.
  • –Checking the audit trail for an amended electronic record.

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.
  • Delete the assessment readiness notes if you do not want them in your controlled version; they are guidance for you, not requirements.

Related documents

This is an original template published by ValiTrac. It does not reproduce the text of ISO/IEC 17025 or of any accreditation body publication, and it does not by itself confer or guarantee accreditation. Customise, review and approve it before use.