Traceability Matrix for Validation

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Traceability Matrix is a correlation model, which emphasizes that any validation protocol shall be prepared to verify that a system or equipment will meet its User Requirements (URS) and pre-approved Design and Functional Specifications (DS and FS). The validation protocols include Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Commissioning (IC), Operational Commissioning (OC), and Performance Commissioning (PQ) for non-portable, large size, and/or complicated equipment or system. Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) if applicable are required for any manufacturing equipment and system, which may impact on products with respect to Safety, Identity, Strength, Purity, and Quality.

In terms of validation traceability, the Design and Functional Specifications shall be based upon their pre-approved User Requirements. Furthermore, the test plans in validation protocols shall be prepared to verify that the equipment or systems meet the pre-approved User Requirements by meeting Design and Functional Specifications.

The following traceability graphical model illustrates a test plan for any piece of equipment or system, which has been designed to meet its user requirements and is to be tested to verify that the design meets the functional specifications. A simple example is given to explain how the traceability matrix works. Note that Computer System Validation (CSV) or Computer Qualification (CQ) documents are independent from the model.

TRACEABILITY GRAPHICAL MODEL

Examples:

In the User Requirement document (Document No. xxx),

1. The RTD shall be calibratable and its calibration range shall encompass the user’s process range. 2. The accuracy and precision of the RTD shall be acceptable for the user’s process requirements. 3. The RTD...
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