Automating Life Sciences SOPs

By Ethan Smith, Metastorm

Life sciences organizations often overlook active process compliance as part of process initiatives. Compliance is typically considered only 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. 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.

The first step is to model mission-critical processes, analyze them, and define standard global processes with regional differences where required by regulations. Traditional, static, 'wallpaper' process models will not suffice.

Connecting

Effective process models must connect together within a defined taxonomy to ensure complete process paths, and be easily consumable across the enterprise for collaboration. They must also include associated documents and content – SOPs, forms, work instructions, etc. – and be accessible in role-specific views for end user consumption. From there, process execution elements are added to the business flows using BPM software – user forms, dashboards, integration services, role hierarchies and more – bringing the process to life.

BPM is being used by top global pharmaceutical organizations to implement processes in new and more effective ways. This is enabled by the ability to take process models and associated requirements elements directly from the modeling tool into the BPM automation engine, which significantly shortens process design and deployment timelines and ensures documentation consistency.

The direct linkage from the process models, SOPs and other documentation to process execution is how active process compliance is achieved. Executing processes on a BPM software platform implicitly means that users are required to follow the prescribed flow and make decisions only as permitted by their defined role and authority in the organization. All of the process information is captured by the BPM software and exports into standard documentation formats to provide validated evidence of process compliance.

Software

For life sciences companies traditionally dependent on SOP documents, deviations and waivers, leveraging an integrated process analysis and BPM software suite provides process discipline and compliance that delivers real value in a number of ways. These include: reduced SOP deviations through enforced process adherence; reduced or eliminated SOP waiver forms; and real-time process visibility and information capture to monitor process compliance.

Benefits also include readily available process documentation and having the ability to easily update process­es and implement process changes when needed. The solution exists today to help life sciences companies achieve and maintain active process compliance across the enterprise. Metastorm is an enterprise software company focused on delivering business improvements through effective business architecture, process analysis and process automation technology.

Ethan Smith is the Director of Life Sciences Solutions at Metastorm. Ethan has extensive experience in business process consulting, including enterprise BPM strategies and centers of excellence utilizing Metastorm ProVision and Metastorm BPM. He has driven process initiatives across R&D, sales operations, incentive compensation, physicians spend management and compliance functions.