Re: Validation and documentation activities required for a custom-made software
The traceabilty matrix will be important for a future auditor if and when they want to establish the successful validation of how you intend to use the system. Without the Matrix, the auditor will not be see that your intended use (defined by the URS) was actually tested (the executed qualifications). If you do not mind the risk, you do not need the matrix. If this risk is unacceptable, then it is worth the purchase.