White Paper: Metastorm BPM® For Life Sciences

In 1997 the US Food and Drug Administration (FDA) issued the first version of Title 21 CFR Part 11, a regulatory standard that governs the use of electronic records and signatures in the life sciences/pharmaceutical industry. Commonly known as Part 11, the regulations require that companies in this industry implement procedural and technical controls to maintain the security and integrity of certain types of information. In particular, the FDA has focused on enforcement in the areas of manufacturing, clinical trials, and product development.

Business Process Management (BPM) has gained tremendous popularity in recent years as a discipline and technology for automating, managing, and controlling critical business processes that include both human-centric and system-based activities. Because BPM software is flexible, adaptable, and scalable to multiple business processes, it provides an ideal framework for accelerating and maintaining compliance with industry regulations. Metastorm was an early leader in the BPM market and today its software suite is deployed in organizations worldwide for both general process improvement and process compliance.