How Do You Write A Software Validation Plan?

How do you validate software?

  • Understand the operational requirement.
  • Produce a specification of the requirements.
  • Choose a trusted supplier.
  • Verify the software's capabilities.
  • Validate the implemented system.
  • Use formal change control, including revalidation.
  • Resolve any non-conformities and deviations.
  • Is Jira validated?

    Key pointers for Jira validation. Jira is an off-the-shelf software package. At the time of writing, the company behind it, Atlassian, is not ISO certified and doesn't support third party audits.

    What is a software validation package?

    Computer Software Validation is a formalized, documented process for testing computer software and systems, required by 21 CFR 11.10(a) and Annex 11, Section 4. We can provide any level of service required, from executing test scripts generated from your existing specifications to writing the entire validation package.

    Does FDA approve software?

    The Food and Drug Administration (FDA) recognizes the extensive variety of actual and potential functions of software applications (apps) and mobile apps, the rapid pace of innovation, and their potential benefits and risks to public health.

    Leave a Comment

    Your email address will not be published. Required fields are marked *