WHAT IS A TRACEABILITY MATRIX?
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More details on specific FDA expectations for PQ can be found in the guidance document below. https://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.
For medical devices, the 21 CFR 820.50 – Purchasing Controls lays down requirements for suppliers’ qualification
Also, the acceptance section of the 21 CFR part 820.80
For medical devices, the 21 CFR 820.65 – Traceability controls lay down requirements for product and quality data traceability
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