System Name

Trace Matrix

This Trace Matrix Template (Template) is being provided by Praxis Management

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V.1.0
8 May 2025
 <system> Trace Matrix

Contents
1 Introduction...........................................................................................................4
1.1 Purpose........................................................................................................................... 4
1.2 Scope.............................................................................................................................. 4
1.3 Definitions, Acronyms and Abbreviations........................................................................4
2 Trace Matrix <Example Contents>......................................................................5
3 Revision History....................................................................................................6
4 Approvals.............................................................................................................. 7

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1 Introduction
1.1 Purpose
The purpose of this Trace Matrix is to confirm the completeness of testing by providing a
map that demonstrates design and testing coverage between the:
 User Requirements Specification
 Functional Requirements Specification
 Validation Protocols

1.2 Scope
Describe the scope of the testing covered by this Trace Matrix. Identify any portion(s) of
the system that are not within scope.

1.3 Definitions, Acronyms and Abbreviations

Term Definition

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2 Trace Matrix
Cross-reference the system’s user requirements to the systems functional requirements.
Then ID the validation document (e.g., OQ or PQ) within with each user requirement and
functional requirement is tested. Use the “Function” column to group related requirements
and provide a visual index for the users of the Trace Matrix.
Two examples of trace matrices are provided. The first example identifies the testing of
each requirement to the specific test case and step ID. The second example identifies
only the protocol ID and name.

Example 1: Trace from User Requirement to Functional Requirement to Protocol Test

Steps

Function User Functional Validation Protocol(s)

Requirement Requirement
OQ-001 “Student Set Up and
Maintenance”, Test Case #1, Step 1.2 and
1.4
3.2.1.1
PQ-003 “Training Coordinator Student
Maintenance”, Test Case 5, Steps 5.1 and
5.2
OQ-001 “Student Set Up and
3.2.1.1.1
Maintenance”, Test Case #1, Step 1.3
3.2.1
The systems OQ-001 “Student Set Up and
shall provide Maintenance”, Test Case #1, Step 1.6 and
Student
the ability to 1.7
Curriculum 3.2.1.2
create a
Creation PQ-003 “Training Coordinator Student
training
Maintenance”, Test Case 7, Steps 7.23
curriculum for
and 7.25
each student
OQ-001 “Student Set Up and
Maintenance”, Test Case #1, Step 1.4
3.2.1.3 PQ-003 “Training Coordinator Student
Maintenance”, Test Case 7, Steps 7.1
through 7.22
OQ-001 “Student Set Up and
3.2.1.3.1 Maintenance”, Test Case #1, Steps 1.8
through 1.11

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Example 2: Trace from User Requirement to Functional Requirement to Protocol

Function User Functional Validation Protocol(s)

Requiremen Requirement
t
OQ-001 Workflow Initiation
Initiating a PQ-001 Document Management
3.2.1 3.2.1
Workflow PQ-010 End to End Process
Verification
OQ-001 Workflow Initiation
Entering 3.2.2.1
PQ-001 Document Management
Monitoring 3.2.2.2
Report 3.2.2 OQ-002 Workflow Processing
Approval 3.2.2.3 PQ-001 Document Management
Information OQ-002 Workflow Processing
3.2.2.4
PQ-001 Document Management
Adding
Comments to 3.2.3 3.2.3.1
a Workflow
OQ-002 Workflow Processing
PQ-001 Document Management
3.2.4.1 PQ-010 End to End Process
3.2.4 Verification
Attaching a
OQ-002 Workflow Processing
Document to 3.2.4.2 PQ-001 Document Management
the Workflow
OQ-002 Workflow Processing
3.2.5.1 PQ-001 Document Management
3.2.5 OQ-002 Workflow Processing
3.2.5.2 PQ-001 Document Management
Referencing OQ-002 Workflow Processing
3.2.6.1
Supporting 3.2.6 OQ-003 Specialist Processing
Documentation 3.2.6.2 PQ-001 Document Management
Submitting PQ-010 End to End Process
Workflow to 3.2.7 3.2.7.1 Verification
Reviewer
Viewing OQ-008 Workflow Viewing
3.2.8.1
Workflow 3.2.8 PQ-002 Document Process Viewing
Information 3.2.8.2 PQ-011 21 CFR Part 11 Compliance
Viewing
Attached 3.2.9 3.2.9.1
Documents
Viewing and
Adding
Comments to 3.2.10 3.2.10.1
Workflow
Approving or
Rejecting a 3.2.11 3.2.11.1
Workflow
OQ-004 Workflow Processing Part II
Notification of
PQ-001 Document Management
Workflow 3.2.12 3.2.12.1
PQ-011 21 CFR Part 11 Compliance
Rejection
Adding 3.2.13 3.2.13.1
Comments
and Modifying 3.2.14 3.2.14.1

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Function User Functional Validation Protocol(s)

Requiremen Requirement
t

the Document
Resubmitting
3.2.15 3.2.15.1
the Workflow
OQ-005 Workflow Processing Part III
Notification of
PQ-001 Document Management
Required 3.2.16 3.2.16.1
PQ-011 21 CFR Part 11 Compliance
Signature
Adding
Comments to 3.2.17 3.2.17
Workflow
Signing or 3.2.18.1
Rejecting the 3.2.18
Workflow 3.2.18.2

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3 Revision History

Document Document Revisions Revision Summary

Version Revision Made By:
(Reference section[s] changed)
Number Date
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4 Approvals

Signature(s) below indicate agreement with the contents of this Trace Matrix document as an
accurate representation of the alignment of system functions, requirements, and validation
protocols.

Document Prepared by:

Function Name Signature Date

Signatures below additionally signify approval of this Trace Matrix document.

Document Approvals:
Function Name Signature Date

***END OF DOCUMENT***

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