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 application?

The model helps ensure that the system will be able to effectively handle a regulated action that occurs in the everyday process of doing business.

A manufacturer, for instance, would use the model to guarantee that a product recall request could be carried out. Proving that this can be done is imperative if the firm is ever audited by a regulatory body. The product lot number on an affected customer’s invoice would have to match the one on a materials batch record. This kind of detail is an example of what is tested during the workflow on the right arm of the V Model.

The total time required to complete all steps in a V-Model varies by project size, but Dr. Ray Glemser, CEO and executive consultant of Glemser Technologies, an IT services and solutions firm serving the life sciences industry, says six to 12 months is typical for traditional large on-site systems, with two to four months of that being dedicated to testing.

See Intelex’s Definitive Guide to Validating Your QMS in the Cloud for a comprehensive look at the modern way of achieving QMS validation.

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