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.
The purpose of the Best Practices in Supply Chain Resiliency and Quality Working Group is to improve medical device quality and supply chain resiliency by expanding MedAccred adoption through the tiers in the supply chain, identifying best practices to supplement efforts in quality assurance and procurement strategies, and to help mitigate supply chain risks.
The acquisition expands MilliporeSigma’s portfolio to a full range of bioreactors, from 2ml to 2000L, and adds to the company’s expertise in monoclonal antibody (mAb) process development.
The updated guidance document clarifies what constitutes a statement of the basis for the deficiency and includes examples of well-constructed deficiencies and industry responses to facilitate a more efficient review process.
Bringing design and quality assurance processes together earlier in the device development process can reduce costs and nonconformances, while improving outcomes.
The two new final guidances are intended to increase transparency to stakeholders on the FDA’s approach to the issuance and tracking of 522 orders and post-approval study requirements.
Inspecting for quality after a process is completed is reactive and outdated. Instead, the future lies in predicting quality and quality issues. For medical device manufacturers, the advantages in predictive quality are so great they simply cannot be ignored.
Jordi labs and its team of Ph.D. analytical chemists developed a proprietary, multi-detector approach to ensure that all extractables are accurately characterized to comply with global materials testing regulatory requirements.
“We are excited that organizations like Innovaccer are working to improve trust in clinical data and help ensure the data’s accuracy and broader usability.”
Double-digit growth of the company’s literature review software platform, DistillerSR, spurred $20 million in funding from the growth investment consortium led by Thomvest Ventures.
