How to make a Traceability Matrix for CSV

Traceability Matrix

 

WHAT IS A TRACEABILITY MATRIX?

Traceability Matrix (TM) Definition

The traceability matrix is a document, in the form of a table with rows and columns, used as an index to quickly assist to find and determine that all relationships with the user requirement specifications are been considered and correlates to each related CSV Computer System Validation documents.

Also, called Requirements Traceability Matrix (RTM) is a document that establishes the links between all different documents sections or requirements within a validation project.

For example, it links each specific user requirements (URS) statement throughout the validation process with their respective Functional Requirement Specification FRS, Installation Qualification IQ, Operational Qualification OQ, Performance Qualification PQ, etc.

Purpose of the Traceability Matrix (TM)

The purpose of the Traceability Matrix is to ensure that all initial pre-established requirements defined for equipment, product, or system are considered in the corresponding protocol test scripts. The traceability matrix is a checklist tool to ensure that all user requirements are considered during the validation project, and for auditors, to review the validation documentation for completeness.

When use a Traceability Matrix?

The traceability matrix is common as part of the CSV computerized system validation projects.

How to prepare a Traceability Matrix?

The traceability matrix may include, but, is not limited to the following sections and information, (as applicable)

•                   Purpose

•                   Scope

•                   Background

•                   System Validation Description

•                   Hardware and Software Equipment Identification

•                   Associated Documents

•                   Definitions and Acronyms

•                   Documents to be traceable with their respective requirement sections & corresponding test scripts linked.

•                   Incident Reports Summary

•                   Conclusions and Recommendations

•                   Final Resolution and Release

•                   Associated Reference Documents

•                   Appendices

•                   History of Change

•                   Document Approval

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More details on specific FDA expectations for PQ can be found in the guidance document below. httpss://www.fda.gov/media/71021/download

Three (3) options to create a traceability matrix protocol

Option 1. You can create a great protocol, using a template.

You can download a free sample of a validation template in .pdf format. 

To see the complete list of the most popular validation templates, click here.

In addition, you can request a quotation to buy online a full validation template document in MS Word format that is completely editable, ready to fill, and adapt to your needs.

Option 2. We can bring you a formal training on how to create your own validation protocols using our template(s).

This option is recommended if you want to learn more about how to build a robust validation protocol. One of our expert(s) will provide online step-by-step training to your team (unlimited assistance) on how to build a reliable validation protocol using a template. You can improve your corporate validation procedures and policies incorporating our template sections.  It includes the template, an exam, and a training certificate for each assistant.  Request a quote now.

Option 3. We can create a customized traceability matrix.

One of our expert(s) will create and prepare for you a customized validation protocol with the inputs and specific information of your company. It may include, online support in document creation, execution, or final reporting, Request a quote online.

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STATUTORY AND REGULATORY REQUIREMENTS

FOR A TRACEABILITY MATRIX

STATUTORY AND REGULATORY REQUIREMENTS

As per 21 CFR 820.60, manufacturers are required to have written procedures for identifying products, components, and related quality information during all stages of receipt, production, distribution, and installation to prevent mix-ups.

The manufacturer has the flexibility to identify products and its related documentation by whatever means they describe in their procedure(s).

Unique control numbers can be used to prevent mix-ups during validation efforts, product ID, test scripts id, etc.

The control number is used for all unique documentation requirements related to products, raw material, component, devices, SOPs, validation documents, etc.

The traceability requirement should not be confused with the tracking regulation under 21 CFR 821. The tracking regulation requires certain devices to be tracked to the end-user or patient through the entire distribution process.

Components of a device or drug product subject to traceability requirements must be identified with a control number where appropriate. Manufacturers must define which documents, test scripts, components, products, equipment, etc are to be identified with control numbers and provide justification for those that are not identified with control numbers.

More details on specific traceability matrix can be found in:

21 CFR 211 Section 211.84 of the US-American GMP regulations for manufacturers of drug products lays down requirements for testing and approval or rejection of components for drug manufacturing.

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.84

For medical devices, the 21 CFR 820.50 – Purchasing Controls lays down requirements for suppliers’ qualification

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1&subpartNode=21:8.0.1.1.12.5

Also, the acceptance section of the 21 CFR part 820.80

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1&subpartNode=21:8.0.1.1.12.8

httpss://www.fda.gov/files/drugs/published/Materials-System–Basic-CGMP-Requirements.pdf

References

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1

https://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

httpss://www.fda.gov/media/94074/download

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1

httpss://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

httpss://ispe.org/publications/guidance-documents/gamp-5

https://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

httpss://www.fda.gov/media/94074/download

https://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

httpss://www.fda.gov/media/94074/download

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1

httpss://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

httpss://ispe.org/publications/guidance-documents/gamp-5

For medical devices, the 21 CFR 820.65 – Traceability controls lay down requirements for product and quality data traceability

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.65

Related topics and resources:

Validation Plan, Installation Qualification, Operational Qualification, Performance Qualifications, Component Qualification, Traceability Matrix, Ppk, Control Charts, Cpk, User Requirements, Functional Requirement Specifications, GAMP5, risk assessment

Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!