Automating life sciences SOPs

Life Sciences organisations 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.

The first step is to model mission-critical processes, analyse them, and define standard global processes with regional differences where required by regulations. The secret to success at this stage is to make the models as robust and all encompassing as possible. Traditional, static, ‘wallpaper’ process models will not suffice. The foundations for SOP automation will be laid within the models. To establish this foundation effectively, the models must connect together with a defined taxonomy to ensure complete process paths with no orphan processes or segments, and be easily consumable across the enterprise for sharing, annotating and collaborating. They must also natively include associated documents and content – standard operating procedures (SOPs), forms, work instructions, etc – and be accessible in role-specific views for user training and guidance.

Building from these comprehensive models, BPM software can then be applied to transform the models into live operating processes. BPM is being used by top global pharmaceutical organisations 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. Process execution elements are added within BPM – user forms, dashboards, integration services, role hierarchies and more – bringing the process to life. 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 user actions and process data are captured in real-time, giving management greater visibility into operations. Further, all of the process information captured in the BPM software exports into standard documentation formats to serve as validated evidence of process compliance.

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. Such as through 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. Also through readily available process documentation and having the ability to easily update processes and implement process changes when needed. The overall reduction of reliance on paper makes the process greener and portable across the globe and produces more efficient and effective business operations.

The events in the global economy over the past year prove that a lackadaisical approach to process visibility and control can be disastrous. The solution exists today to help life sciences companies achieve and maintain active process compliance across the enterprise – and provide the foundation for a bright and prosperous future. Metastorm is an enterprise software company focused on delivering business improvements through effective business architecture, process analysis and process automation technology. Due to the many process challenges life sciences companies face – from safety to innovation to time-to-market – our software has proven to be a very valuable asset. 

Ethan Smith has extensive experience in business process consulting in life sciences. He has driven process initiatives across Research and Development, Sales Operations, Incentive Compensation, Physician Spend Management, and Compliance. He has delivered well over a dozen BPMS implementations in the industry and developed enterprise BPM strategies, and Centers of Excellence. Mr. Smith currently serves as the Director of Life Sciences Solutions for Metastorm.