Validating software requirements
In our experience, the most common reasons for overlooked hazards are: Once you have completed your architecture and design review, software verification and validation activities will need to be performed to assess whether your software system is in a state of control.
Based on our experience, clients will sometimes proceed with software verification / validation activities without completing the necessary pre-requisites (i.e. We highly recommend that our clients have a clear understanding of how to achieve compliance throughout the complete software lifecycle, so that verification and validation activities take place once the software has been configured to its usable form.
We are estimating that about 3-6 months of consulting work is required in order to get our new companies audit-ready.
The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software. As you read through this section of ISO 13416, there are a few details to focus your attention on.This blog post discusses the inclusion of new requirements for quality system software validation in ISO 13416.Section 4.1.6 outlines the process for validating computer software used in the quality system as follows: 4.1.6 The organization shall document procedures for the validation of the application of computer software used in the quality management system.When potential hazards are not properly identified, no control measures can be implemented to address and mitigate the potential risks.The addition of certain tools into your quality system regarding software can help better identify commonly overlooked hazards.