Requirment Tracebility!

GOOD DOCUMENTATION PRACTICE (GDocP) RTM (REQUIREMENT TRACEABILITY MATRIX)
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The traceability Matrix enables the requirements to be traced to their final implementation, identifying at each stage the product components, modules and units and their contribution to each of the requirements. It helps track/trace all requirements through the various life-cycle phases to ensure that all requirements have been incorporated.

REQUIREMENT TRACEBILITY MATRIX TEMPLATE generally consist columns as

  1. Verification Phase
  2. User Requirement description
  3. Source of Requirement Change
  4. Validation & project Plan
  5. Functional Specification
  6. IQ
  7. OQ
  8. User Acceptance Testing
  9. Performance Qualification & relevent section details for execution purpose or tracebility purpose.

Happy Reading !

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If you have a blank template kindly post one.

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Hi,

Unable to post the .xls file…in forum :frowning:

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[quote=siddhipharma]Hi,

Unable to post the .xls file…in forum :([/quote]

Can you send me the files so I can test if everything is ok.

graham.okeeffe@premiervalidation.com

Cheers

5

I have created traceability matrices for clinical trial applications that just consist of the performance qualification requirement identification number and brief title of the requirement and the identification number of PQ test script that tests the requirement. The auditors usually want to see the requirement and how it was tested.