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What should be included in a traceability analysis?

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

A Traceability Analysis links together your product design requirements, design specifications, and testing requirements. It also provides a means of tying together identified hazards with the implementation and testing of the mitigations. FDA recommends that you submit for review explicit traceability among these activities and associated documentation because they are essential to effective product development and to the understanding of product design, development and testing, and hazard mitigations. The Traceability Analysis commonly consists of a matrix with line items for requirements, specifications and tests, and pointers to hazard mitigations. It is possible to document traceability simply through a shared organizational structure with a common numbering scheme; however, FDA recommends that you include some mechanism, such as a matrix for guiding the reviewer through the information you submit.

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