Validating software requirements

Most auditing organizations have either cut off ISO 13403 recertifications or are doing so very soon.So, if you have not started the process of transitioning your Quality Management System to comply with the new 2016 updated standard, it is time to get moving.If you decide to use a Gap Analysis during software evaluation, we recommend starting with a requirement review, which includes a user, system, and software level analysis.Requirement management serves as the foundation for software development and use within the quality system.Maintaining a state of control of your software and assessing all software changes after verification/validation is critical to compliance.Properly assessing your company's QMS software can be difficult to do.Luckily, the Greenlight Guru electronic quality management system (e QMS) provides users with an easy-to-use application and a validation package that helps support their customers through this process.As I previously mentioned, I was recently helping a client through their transition audit.

The first detail to focus on is the creation of a ­quality procedure, or SOP, for the evaluation and validation of software used in the quality system.

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.

The procedure should reference ISO 13416 and outline a risk-based approach to evaluating current, updated, and new software that will be used in the quality system.

This procedure will help guide your company to properly evaluating all QMS software throughout its lifecycle.

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