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Protocol · VAL-P04

Environmental Monitoring System Validation Protocol

Validation of an EMS including sensors, alarms, data integrity and 21 CFR Part 11 / Annex 11 controls.

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Purpose

To define the validation of an environmental monitoring system (EMS) - the sensors, transmitters, data acquisition, software, database, alarming and reporting used for continuous monitoring of temperature, humidity and other parameters in GMP / GDP storage and processing areas - so that the system reliably records accurate data, alarms on excursions, protects data integrity, and is fit for its intended use.

What is inside

14 sections, about 4 pages when printed.

  1. 1. Purpose
  2. 2. Scope
  3. 3. Responsibilities
  4. 4. References
  5. 5. Definitions
  6. 6. Validation approach
  7. 7. Acceptance criteria
  8. 8. Test design (OQ)
  9. 9. Performance qualification
  10. 10. Ongoing controls
  11. Deviations
  12. Data integrity
  13. Report
  14. Approval

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

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.