What is RTM & Its importance in CSV?


 

In Earlier post we understood What is Configuration Specification, Its Roles & Elements in Computer system Validation.

Now in this article we are going to understand What is Traceability Matrix, Its Use, & Benefits   in Computer system Validation.

 

What is Traceability Matrix? (TM)

A TM is a document that co-relates any two-baseline documents that require a many-to-many relationship to check the completeness of the relationship.

It is used to track the requirements and to check the current project requirements are met.


What is RTM?

RTM is a method used to establish the relationship between documents. Its purpose is to ensure that requirements have not only been traced to the appropriate design elements but also that requirements have been met through test or other means of verification.

The traceability matrix is a tool both for the validation team, to ensure that requirements are not lost during the validation project, and for auditors, to review the validation documentation.

The RTM traces the deliverables by establishing a thread for each requirement, from a project’s initiation to completion.

 

Data Integrity App
Traceability Matrix is often used to:

•          Track Requirements: Objectives being met by the current process and design?

•          Ensure that all requirements that are defined for a system, are tested in Test Protocols

•          Help auditors in reviewing the validation documentation

•          Assist in creation of an project plan tasks, Request for proposal, deliverable documents, and test scripts.

•          Form the basis of a projects SCOPE, by incorporating specific requirements and deliverables that will be produced.

 

What do the regulations say?

FDA (Code of Federal Regulations Title 21) and TGA (PE 009-8 – 15 January 2009) currently do not have any specific regulation around requirements traceability.

However, the European Commission (Volume 4 Annex 11 Clause 4.4 (part)) and PIC/S Guide to Good Manufacturing Practice for Medical Products (PE 009-11 1 March 2014 Annex 11 Clause 4.4) do state “User requirements should be traceable throughout the life-cycle.”.

 

Types of Traceability Matrix

•       Forward traceability: This matrix is used to check whether the project progresses in the desired direction and for the right product.

•       Backward or reverse traceability: The purpose behind this type of traceability is to verify that we are not expanding the scope of the project by adding code, design elements, test or other work that is not specified in the requirements.

•       Bi-directional traceability (Forward + Backward): This traceability matrix ensures that all requirements are covered by test cases. It analyzes the impact of a change in requirements affected by the in a work product and vice versa.  


A Matrix is considered to be bi-directional when it:

•          tracks the requirement “forward” by examining the output of deliverables

•          looks at the business requirement that was specified for a particular feature of product “backward”

 

Advantage of RTM

•       It confirms 100% test coverage

•       It highlights any requirements missing or document inconsistencies

•       It shows the overall defects or execution status with a focus on business requirements

•       It helps in analyzing or estimating the impact on the QA team's work with respect to revisiting or re-working on the test cases


 “Trust but Verify “ Ronald Reagan

 

Across the internet, there are millions of resources are available which provide information about Everything.

 

If you found all content under one roof then it will save your time, effort & you will more concentrated on your important activity.

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Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.

 

Data Integrity App Include 

- Basic Data Integrity Concepts

- ERES & Its Requirement

- CSV & Its best practices 

- Mock Inspection and General Q&A

- Checklist for inspection

- Inspection Readiness

- Useful SOP’s

- Stay Regulatory Compliant.

 

“Stay One Step Ahead in Pharma IT Compliance” 


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