Remember that design inputs (when properly devised) consist of functional, performance, and interfacial requirements that may spread across more than twenty different categories (i.e., safety, sterility, biocompatibility, mechanical, manufacturing, packaging, labeling, etc.). This is germane because ultimately, each design input (of which there could be hundreds) might demand both a hardware and a software solution, or just a hardware solution, or just a software solution. Moreover, each of those must be verified and, as applicable, validated. Traceability between each input and the resulting outputs (whether hardware or software), verification, and validation must be maintained and should be accomplished using a trace matrix (or multiple trace matrices if needed).
Consider first organizing and laying out the design inputs in a master trace matrix such that the aforementioned fundamental input categories (whether ultimately leading to software or hardware) are properly distinguished and maintained. This step is critical for assuring that the resulting design outputs (whether software or hardware) will ultimately cover the full scope of the inputs. Then, for inputs ultimately leading to a software-based solution, consider adding a segue to corresponding SRS elements, thereby transferring their traceability to a separate SRS trace matrix used solely for traceability of software solutions and their corresponding verification and validation. The same type of segued approach could be used for the hardware solutions, or the hardware design traceability could just remain in the master matrix.
Hope this helps,
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Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com© Copyright 2019 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 01-Apr-2019 11:48
From: Anonymous Member
Subject: design inputs and traceability matrix
This message was posted by a user wishing to remain anonymous
Hi everyone,
For a system with both hardware and software components, how can the design inputs for both hardware and software be documented in the input traceability matrix? We have always coded software input requirements starting with SRS, but not sure how the hardware inputs can be coded in a coherent way in the design traceability matrix. Does anyone have suggestions?
Thank you.