If teams across regulatory, quality and safety functions—as well as further across the life sciences enterprise—are to be able to think and operate in more agile and dynamic ways to achieve what is necessary, then the way that they generate, manage and store documents and data needs to change fundamentally. Regulatory changes (e.g., towards data-driven submissions activity, more dynamic item/label tracking, etc.) are prompting some of this change, but cannot be relied upon exclusively to drive the process improvements now needed.
In this series we examine the future of the medical device industry—from manufacturing to the consumer-patient experience.
Data integration is doing much to enhance regulatory information management. Life sciences companies are increasingly discovering useful interdependencies between data, documents and RIM processes. The next step is to put this data to work to improve efficiency.
The latest regulations for human and veterinary medicinal products, as well as medical devices, include the mandate to set up databases with detailed information about available products. These databases must be realized and implemented in the near future, and require a concerted effort now if tangible real-world benefits are to follow.