When it comes to testing, the most significant difference between CSV and CSA is that CSV focuses on a “test everything” approach, while CSA encourages us to use critical thinking to test more effectively. The following article outlines how companies can identify the appropriate degree of testing rigor for risk-based CSA validation to ensure the least burdensome approach.
In leveraging the valuable insights delivered by real-time location systems (RTLS) technology, hospitals and healthcare facilities are able to undergo the kind operational overhaul they so desperately need, boosting ROI while simultaneously allowing for better working conditions for staff as well as more focused, immediate care for patients.
The FDA is requesting feedback on three new draft guidances related to clinical trials, including how they should be applied to increasingly diverse trial types and data sources.
AAMI and the British Standards Institute (BSI) have jointly published new guidance documents on performing risk management for machine learning or artificial intelligence incorporating medical devices.
A Venture Capitalist recently joked that to fund a startup, all one must do is choose a URL that ends in ‘.ai’. Although he was not serious, it was an acknowledgment that companies pursuing AI are getting much attention, and there is a fear of missing out (FOMO) in the investment community if one of…
An adhesive developer explains why skin is so challenging to adhere to, why it’s never too early to explore skin-adhesive options for your wearable device, and recent milestones in stick-to-skin adhesive longevity.
Smart hospitals are revolutionizing health care with the help of AI, IoT and robotics. Following are the latest technology and data analytics tools and trends that are helping these hospitals of the future provide safer, more personalized care.
Regulatory requirements for computer systems validation (CSV) have long been in place, but their compliance requires considerable time and resources. In the life sciences industry, traditional validation processes add to project timelines and costs, affecting time to market and preventing the deployment of newer versions of software. In addition to improving accuracy and coverage, automated CSV processes can create the same artifacts as manual execution and expedite the upgrade timeline.
“Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products” and “Artificial Intelligence in Drug Manufacturing” were developed to support the use of AI/ML while addressing concerns related to security, bias and risk, and spur feedback and discussion from stakeholders.
The draft guidance covers DCT design, informed consent, the use of remote clinical trial visits, safety monitoring and software used in conducting DCTs for drugs, biological products, and devices. The comment period is open until August 1, 2023.
