Documentation and Traceability: Ensuring Your Software is Doing What it Should

Software validation is at the heart of the Quality process. It’s the method by which manufacturers provide objective, documented evidence that their processes, equipment and computerized systems are checked and validated to ensure the quality of their final products.

Traditional on-premise validation of a Quality Management System (QMS) typically utilizes a “V Model” workflow. The process begins on the top left, with the left side defining a series of required deliverables. Once these are mapped out, you can configure and develop the system. Finally, as illustrated on the right arm of the model, the system is tested, with these actions being traced back to the previous planning stages.

The model helps organizations answer key questions about the project, such as:

  • What are you trying to accomplish?
  • What are the roles?
  • What documents are you going to generate?
  • Who approves them?
  • What process will you follow to develop this