White Paper: Automating Life Sciences Compliance

By Ethan Smith, Metastorm Inc.

Life Sciences organizations often overlook active process compliance as part of process initiatives. Compliance is typically considered to ensure inclusion of process steps in workflows and SOPs to address 21 CFR Part 11, GCP, GAMP or other regulatory requirements. The missing piece for sustainable compliance is the automation of business processes (SOPs essentially) in a controlled way — a way that ensures that the appropriate steps, rules and other compliance factors are clearly documented and enforced during process execution. In addition, Life Sciences companies must have a proactive, systematic way of controlling access, tracking actions and capturing an accurate, "on demand" audit trail of both human and system actions. Effective deployment of process modeling and business process management (BPM) software has helped a number of the world's largest Life Sciences companies successfully accomplish this — on a relatively short timeline and for a reasonable cost.