Posts Tagged 'Life Sciences'
Medical AI: Software Diagnosing Health Issues?
May 6, 2024
The AI boom has prompted conversations across the internet and news about bots replacing humans in a variety of fields (most commonly writing and coding). But what about the healthcare and medical industries? These are typically thought of as requiring a human’s touch, intuition, and nuance — but that hasn’t stopped some from suggesting that AI robot doctors will be replacing all humans in the coming years.
As a company, we’ve seen almost two decades of software trends and shifts, as well as how these changes impact different industries. We also work closely with dozens of partners in the biotech and medical fields that rely on cutting-edge software every day. With that in mind, let’s discuss AI’s impact on healthcare today and where we anticipate it going.
We Just Finished Our FDA Audit - Scheduled for 5 hours, Done in 90 Minutes With Spira
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!
Read MoreImportance of Testing Software for Life Sciences
August 23, 2023
In the vital fields of life sciences and healthcare, the integration of technology has been pivotal. This industry relies on various software solutions ranging from medical device control to telehealth platforms, all demanding rigorous testing to ensure accuracy, safety, and regulatory compliance. Software Quality Assurance (QA) plays an essential role in upholding the integrity and reliability of these digital tools. At Inflectra, we offer Rapise, a cutting-edge solution for automated testing, providing the precision and security required in these precision-driven sectors. With Rapise, you can confidently meet the industry's demands, ensuring software that resonates with patient trust and well-being.
Recap: Uncovering the Security and Privacy Challenges in AI-powered Health Services
August 3, 2023
On June 29, 2023, Inflectra hosted a panel discussion on Uncovering the Security and Privacy Challenges in AI-powered Health Services in continuation of our Influence of AI and ML Technologies - Expert Panel Series. This insightful conversation, that took between two of Inflectra's experts, focused on security vulnerabilities, privacy concerns, and liability for intellectual property related to the use of AI in the healthcare industry. Continue reading to see the key takeaways, recording, and more.
Recap Blog -Transforming Healthcare QA with SpiraTeam: Achieving Excellence in Testing
June 29, 2023
On June 28, 2023, Inflectra hosted an exclusive webinar to present how SpiraTeam, Inflectra's test management solution, can revolutionize healthcare Quality Assurance (QA) processes. This webinar showcased how to achieve excellence in testing, streamline workflows, and ensure the highest level of patient safety and regulatory compliance.
See our recap blog to view more details on the key takeaways, recording, slides, and more.
Read MoreRecap: Embedding GAMP Compliance into Digital Health Software
April 3, 2023
Inflectra launched a new webinar series called "Journey into Risk Management" on March 29, 2023, with the first event hosted by Dr. Sriram Rajagopalan. The webinar, titled "Embedding GAMP Compliance into Digital Health Software," focused on implementing validation testing for Good Automated Manufacturing Practice (GAMP), which is a general automation manufacturing process, often used in e-health software development and validation as a Risk-Based Approach to Compliant GxP Computerized Systems.
Read more to see the topics covered, full recording, and presentation!
Read MoreRecap: Agility in Healthcare – Insights from Clinical and Surgical Settings
March 9, 2021
On March 4, we hosted a webinar on Agility in Healthcare Services: Clinical and Surgical Settings with Sriram Rajagopalan, Ph.D. We had a few technical difficulties during the event, which we overcame by re-recording the event. In this recording, our esteemed speaker covers the following topics:
- Stages of agility in the healthcare setting
- Responsibilities of Healthcare professionals toward outcome management
- Risk Management and Process Guidance in Clinical and Surgical Settings
- Applying agile thinking in the Healthcare setting.
The webinar presentation, blog, and recording are enclosed here 👇
Read MoreUsing 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.
Read MoreWebinar 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.
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.
Read MoreConfiguring 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.
Read MoreConfiguring 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.
Read MoreConfiguring 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.
Read MoreConfiguring 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.
Read MoreWhen the FDA Sheriff Comes to Town - You Need to be Ready!
April 29, 2016
In this morning's Washington Post, there was an article about 'The new sheriff in town' describing how the new biotechnology and drug screening startups in Silicon Valley are colliding with the conservative, formal testing philosophy of the United States Food & Drug Administration (FDA).
Spira 5.0 Preview - Digital Signatures
September 18, 2015
When developing software, systems and hardware for use in medical devices, healthcare IT systems or pharmaceutical processes, you need to follow a requirements and quality management process that complies with the FDA Title 21 CFR Part 11 set of Federal Regulations. Part 11 (as it's more commonly called) defines the criteria under which electronic records and electronic
signatures are considered trustworthy, reliable, and equivalent to paper
records.