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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

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

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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