TOOL 2 OF 6

Review the supplier

Record what the supplier has checked and what your team still needs to check.

No system named yetVersion not recorded · Owner not recorded

Edit system details

System nameVersion / configurationOwner or responsible role

Review the intended use and GxP answers

You can start here. Check system use when you are ready to connect the work to a system assessment.

Who provides the software?

Software providerSupplier / service name

Has your team reviewed the supplier?

Record the supplier assessment or approval reference.

Are software development and change controls suitable?

Review how versions, changes, defects and releases are controlled.

Do you have the actual test results?

A certificate alone is not enough. If you will not use supplier tests, record the local test plan and reason for excluding them.

Do those results cover your functions, version and setup?

Check configuration, interfaces and environment. If you will not use supplier tests, reference the local test plan.

Have known problems and local differences been reviewed?

Record defects, exclusions and extra checks needed at your site.

Are support, changes and record responsibilities agreed?

Include notice of updates, access, backup, recovery, records export and your responsibilities.

Which existing results can you use, and why?Name the functions and test references. Record gaps and checks your team must still perform.

What this means

Keep local testing in the plan

Supplier results can support your work only when their coverage and quality have been reviewed. A supplier approval or certificate alone does not demonstrate that your use works.

Why?

Existing results are useful when you know what was tested, on which version and setup, what happened, and what remains different at your site.

What still needs attention 8

These items stay open until you record the answer or supporting evidence.

Name the supplier or service.Record the provider for this system.
Confirm who supplies the software.Choose supplier or internal development.
Has your team reviewed the supplier?Not yet confirmed.
Are software development and change controls suitable?Not yet confirmed.
Do you have the actual test results?Not yet confirmed.
Do those results cover your functions, version and setup?Not yet confirmed.
Have known problems and local differences been reviewed?Not yet confirmed.
Are support, changes and record responsibilities agreed?Not yet confirmed.

Keep a copy of your work

Download a PDF for review. Save the working file to continue another day or on another device.

Open working file