Unified Business Processes For Smart Control Of Medical Device Operations
The bane of medical device companies is FDA compliance of design and document control. As a result, they invest in the necessary resources and systems to meet the regulatory requirements of research and development. However, that is shortsighted. As products are approved and move into production, document and process controls must extend to manufacturing, contract operations, sales and post-sales service operations.
The majority of device manufacturers do not have the information systems they need to easily keep all these processes under control. While the trend is to automate more functions, the common approach of implementing stand-alone systems delivers only minimal benefits. Manufacturers that rely on either manual processes or stand-alone information systems struggle to remain in FDA compliance. They are also inefficient when documenting standard operating procedures, preparing for audits, or deploying corrective actions. And they are more prone to product recalls, inaccurate order promises, and unresponsive post-sales services, which limits market success.
Until recently companies had limited options. There were few systems that offered fully integrated product data and document management to meet 21 CFR Part 11 requirements. None could be scaled up from design to include financials, sales, marketing, manufacturing, distribution, post-sales call center support or service management in a global environment.
This paper introduces a fully integrated solution from Industrial & Financial Systems (known as IFS) that meets FDA regulations 21 CFR Part 820 and Part 11. The IFS Medical Device solution is in use in FDA validated operations. IFS integrates operational processes in a componentized architecture. This enables incremental implementations as well as scalable and real-time access to product and operational information and automated alerts regardless of function or location. As a result, device manufacturers are now able to rapidly comply with FDA regulations and gain efficiencies for improved time-to-market, customer service, cross-operational communications, and replenishment processing.