Posts Tagged 'Compliance'

We just did our FDA Audit. It was scheduled for 5 hours. With Spira It Took 90 Minutes!

March 18, 2024

Since SpiraPlan is considered a validated platform to plan, develop, manage and test solutions for the life sciences industry, we are required to undergo an annual external audit of our quality and security systems. This audit has to comply with 21 CFR Part 11 as well as the ISO:9001 and ISO:27001 standards. Normally a desk audit of a software provider like Inflectra would take about 5 hours. However because we use SpiraPlan ourselves, it only took 90 minutes, and even better, it ended with no observations or issues!

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Reinventing The Automotive Industry Safely With Software

April 17, 2023

The automotive industry is going through significant change, with the rapid migration to Electric Vehicles (EVs) and simultaneous introduction of autonomous driving technologies. Both of these changes are resulting in the rise of Software Defined Vehicles (SDV) where cars are becoming technology platforms, and car OEM manufacturers are becoming software companies as much as hardware manufacturers.

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Webinar Recap: NERC-CIP: Top Testing & Compliance Challenges & How To Address Them

June 4, 2020

On June 2, 2020, Inflectra's Adam Sandman and NVP Software Solutions' Neil Price-Jones hosted a joint webinar on NERC-CIP: Top Testing & Compliance Challenges & How To Address Them. 

The webinar covers the following:

  • Key challenges in testing and developing software for the energy industry
  • Key NERC-CIP requirements for operating North America's bulk electric system
  • Best Practices in addressing NERC-CIP compliance
  • Technology and tools: How SpiraPlan can transform your testing, verification, and compliance of NERC-CIP. 

If you missed the webinar, you can watch the recording here 👇.

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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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Product Development Tools - The Top 10 Features

December 12, 2019

SpiraPlan is an easy to use, complete solution for managing your product development lifecycle. In this article we discuss the top 10 features you should look for in a product development tool, and why you should choose SpiraPlan over other tools on the market that offer features for product development.

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Recording of Software Testing, Validation & Compliance in Healthcare Webinar

May 17, 2018

Thanks to those who attended our recent webinar discussing the challenges and opportunities testing and validating software and systems in the life sciences and healthcare industries. We have published a recording of the webinar and Q&A.

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Inflectra's Tools That Solve Software Development & Testing Challenges in the Financial Sector

April 11, 2018

Are you working in a highly regulated industry, such as finance or banking?

Do you have to deal with constantly changing regulatory compliance needs in software development and testing? 

Are requirements traceability, security and privacy, system's speed and agility and data interoperability some of the areas that require constant monitoring, upgrading and investment?

Inflectra offers a powerful set of tools: SpiraTeam, Rapise and SpiraPlan - that work together seamlessly to solve all these problems and many more. 

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Recording of Testing & Compliance Challenges Webinar for Healthcare in the Cloud

March 12, 2018

In this presentation we discuss some of the unique testing and compliance requirements for IT projects in healthcare and the life sciences. We discuss the move to the cloud, the opportunities and challenges it will bring, and how the Inflectra platform can help. We then have a practical demonstration of our two products - SpiraTeam and Rapise - that can help you achieve compliance faster and more affordably than ever before.

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