What is an RTM?

Ok I’m fairly new to validation and have never even heard of an RTM, or if I have it would have been under a different name.
Could someone please explain what an RTM is and when it would be used?

Requirements Traceability Matrix

Traceability is a process to ensure that all requirements are met and can be traced to the appropriate design elements. It also ensures that all requirements are verified and can be traced to test or verification activity that shows the requirement has been met.

Basically you make a matrix. Start with each URS requirement in the left column. In the next column show how the FS/FRS meets the URS - normally by a simple cross reference. Add columns as you go for DS etc., through to FAT, SAT and even verification (GAMP5) or validation (GAMP4).

Refer to Jan/Feb 2006 ISPE Pharmaceutical Engineering for more details.

Jan/Feb 2006

GAMP® Traceability for GxP Regulated Applications

“Good traceability yields benefits” – guidance from the GAMP® Forum on achieving the correct level of traceability between requirements, design, and testing documents for regulated GxP applications.

Just to add …

this matrix provide assurance that the Requirements are fully covered in the validation documentation (Reference section) & it is a method of quick verification for relevent functionality testing during validation (At a glance summary sheet).

RTM is prepared before starts testing an application. As RTM is used to trace the requirements with test cases.
The RTM(Requirements Trace Matrix ) is used as a test planning tool to help determine how many tests are required, what types of tests are required, whether tests can be automated or manual, and if any existing tests can be re-used. Using the RTM in this way helps ensure that the resulting tests are most effective.The RTM can serve many purposes over the course of a development project. Initially, it can be used as a planning tool. Once the tests are developed and Validation Testing has begun, the RTM can be used to help determine the extent of regression test required based on the relationship be requirements, design, code, and tests.When it becomes necessary to perform regression testing, the accurate information included in the RTM will be invaluable in helping to select a reasonable set of tests to run.