Medical device manufacturers must adapt to changing business needs and regulations, and yet continually adhere to the standards provided by the Food and Drug Administration’s (FDA) guidelines. This is challenge for an industry facing shorter product lifecycles, global operations and supply chains, strategic partnerships, and increased legal and regulatory scrutiny.
Intellect offers a highly flexible and configurable software solution to help enable medical device manufacturers to be compliant with regulations around the world, and at the same optimize business operations. Intellect offers a comprehensive solution for collecting, organizing, and reviewing documents required to meet FDA requirements, as well as automated business processes and workflow, with approvals, notifications, reminders and much more to address a wide array of regulations.
Since 2000, Intellect solutions have successfully helped companies automate and streamline business processes, documentation, approvals and related tasks to meet compliance and regulatory requirements. Intellect’s best practices and industry expertise help organizations to comply with regulations that include 21 CFR Part 11, 21 CFR Part 820, ISO 9001, ISO 13485, and many other industry standards.
Documentation should be reviewed at each phase of production, however, documents and tasks are often incomplete, and resources are wasted by searching for the require documentation, and thereby impacting production.
🗸 Intellect ensures that all documentation, for production and for FDA inspection, are readily available.
All new product designs must be documented, reviewed, and approved by the appropriate personnel, and this process can often create bottlenecks that slow down a new product launch.
🗸 Intellect ensures a faster turnaround by digitizing and automating the review cycle, including reviews, collaboration, routing, escalations, follow-ups, and approval of product changes, and at the same time ensuring regulatory compliance.
Intellect’s software and domain expertise enables organizations to effectively comply with regulations that include 21 CFR Part 11, 21 CFR Part 820, GMP, ISO 13485, ISO 9001, and many additional industry regulations.