So at this early stage it is required to execute a Validation Risk Assessment protocol against the end user's requirements.This step is purely to ensure that the more obscure pieces of ancillary equipment and support services are fully understood and their requirement investigated, priced and included in the final issue of the URS; which will be sent out with the Request to Tender.This is an essential stage if the URS is to accurately define what depth and scope of validation is appropriate for the verification that the software will deliver all the requirement detailed in the URS.
Code inspections and testing can reduce coding errors; however, experience has shown that the process needs to be complemented with other methods.One such method is Static analysis is used to identify potential and actual defects in source code.A code verification solution that includes abstract interpretation can be instrumental in assuring software safety and a good quality process.It is a sound verification process that enables the achievement of high integrity in embedded devices.They must cover all aspects of using the program and be sufficiently detailed to enable the development team to clearly and concisely understand what the future product plans are.
This stage develops and expands the end user’s requirements, and drills down to a sufficient level of detail required for the development team.
As each detailed requirement document is completed, it is subjected to This task should be structured in parallel with defining the detailed requirements.
The source code development team executes the detailed requirements and the technical architecture.
This process is best commenced only when both parts of the requirements document have been completed, reviewed and approved.
The QA team must sit in at all stages from conception to completion and hand over to end user.
This would appear to mean that the original all embracing approach to all electronic records is to be dropped and the rigors of part 11 applied only to the data that directly affects product quality and safety, and record (of the product) integrity.