Posts Tagged 'Validation'

Using the SpiraPlan Document Workflow Enhancements for GxP CFR Part 11 Projects

January 28, 2021

We're very excited about the upcoming release of SpiraPlan 6.7.1 for both our cloud and on-premise customers. In addition to the powerful new tools for developers and DevOps engineers, we also have some new document management enhancements that will be amazing for customers working in the life sciences, especially on GxP projects that have to follow FDA / EMA rules such as 21 CFR Part 11.

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Webinar Recap: How To Accelerate Software Testing, Validation & Compliance Of Your Medical Trials

March 30, 2020

On March 25 2020, Inflectra's Adam Sandman headlined a live webinar called: How To Accelerate Software Testing, Validation & Compliance Of Your Medical Trials. The webinar focuses on compliance with HIPAA and FDA 21 CFR Part 11 and discusses how SpiraPlan makes that compliance front and center of your software development and testing initiatives. 

If you missed the webinar, please enjoy this recap, complete with a video recording.

Webinar Agenda:

The webinar covered the following areas: 

  • The urgency around Software Validation & Testing
  • Best practices in Software Validation & Testing
  • SpiraPlan Compliance Features: Electronic Signatures, End-to-End Traceability, Audit Trails.
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Configuring SpiraTeam for Testing in Validated Environments (Part 4)

December 7, 2017

At Inflectra we like to make the lives of customers easier and share knowledge. We have lots of customer in the life sciences industries using SpiraTeam to manage and test medical device systems and products. Since such products have to follow the FDA 21 CFR Part 11 requirements, we thought it would be useful to highlight some of the best practices we have for configuring SpiraTeam in such environments. This is the fourth article in the blog series, and covers the configuration of the release workflows.

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Configuring SpiraTeam for Testing in Validated Environments (Part 3)

December 5, 2017

At Inflectra we like to make the lives of customers easier and share knowledge. We have lots of customer in the life sciences industries using SpiraTeam to manage and test medical device systems and products. Since such products have to follow the FDA 21 CFR Part 11 requirements, we thought it would be useful to highlight some of the best practices we have for configuring SpiraTeam in such environments. This is the third article in the blog series, and covers the configuration of the test case workflows.

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Configuring SpiraTeam for Testing in Validated Environments (Part 2)

November 29, 2017

At Inflectra we like to make the lives of customers easier and share knowledge. We have lots of customers in the life sciences industries using SpiraTeam to manage and test medical device systems and products. Since such products have to follow the FDA 21 CFR Part 11 requirements, we thought it would be useful to highlight some of the best practices we have for configuring SpiraTeam in such environments. This is the second article in the blog series, and covers the configuration of the requirements workflows.

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Configuring SpiraTeam for Testing in Validated Environments (Part 1)

November 20, 2017

At Inflectra we like to make the lives of customers easier and share knowledge. We have lots of customer in the life sciences industries using SpiraTeam to manage and test medical device systems and products. Since such products have to follow the FDA 21 CFR Part 11 requirements, we thought it would be useful to highlight some of the best practices we have for configuring SpiraTeam in such environments.

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