Mapping Jama Connect Test Terminology to Medical Device Verification and Validation (V&V) Documentation

Published Date: October 13, 2026
Validated: Yes
Audience: Everyone
Products and Versions Covered:

All Jama Connect® versions

Summary

This article explains how Jama Connect's Test Management functionality maps to common medical device verification and validation (V&V) document terminology and how Jama Connect artifacts can be used to generate QMS documents.

Full definitions of each test management capability can be found in the Jama Connect Help Guide.

Note: This article describes a common mapping. Medical device document names and boundaries vary by organization; use your QMS definitions when deciding how to structure and approve the resulting documents.

Resolution

In common QMS terminology, the Verification and Validation (V&V) Plan describes the high-level testing approach. Individual test protocols define the specific procedures and acceptance criteria for a defined testing scope. Test reports document the execution of testing prescribed in the test protocols.

Jama Connect manages this information across multiple Test Management artifacts rather than representing each QMS document as a single item.

Document Mapping from Jama Connect to QMS

Common QMS Document	Content Used from Jama Connect	Comments
V&V Plan	Collection of Documentation items in the Explorer that describe the overall test strategy.	Describes the overall verification and validation strategy, scope, and organization of testing.
Test Protocol (pre-execution)	Test Plan + Test Cases + Test Cycle/Test Runs (with no results)	Combines the Test Plan's scope with the applicable Test Cases, including test steps and expected results. Execution results are excluded.
Executed Test Protocol / Test Report	Test Plan + Test Cases + Test Cycle/Test Runs (with results)	Contains the same protocol information along with recorded execution results from the Test Runs.
V&V Summary Report	Requirements + Test Cases + Test Runs	Summarizes requirement verification coverage, test execution status, and results using traceability relationships.

Generating QMS Documents

Test Cases define reusable test procedures, including test steps and expected results. Test Plans organize the Test Cases into a defined testing scope, while Test Cycles create the individual Test Runs used to capture execution results.

Because QMS documents often combine information from multiple Jama Connect artifacts, custom Velocity reports may be needed to generate documents that match an organization's required format.

For example, a single custom report can generate both blank and executed test protocols by including or excluding Test Run results. A separate traceability-based report can generate the V&V summary.

Key takeaway: A Jama Connect Test Case is not necessarily a complete test protocol. The protocol is typically assembled from the Test Plan, its associated Test Cases, and the relevant Test Cycle/Test Runs.

Additional Resources (for all external articles)

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