Paperless, Release by Exception Electronic Workflows

If your current work processes are causing delays in getting your manufactured products released for sale, you may want to catch Christie Deitz‘, Electronic Workflow for a Bioreactor presentation. She’ll be co-presenting with an automation engineer from a leading pharmaceutical manufacturer at the 2010 World Batch Forum North American Conference, which will be held May 24-26 in Austin, Texas. You may recall Christie from earlier Life Sciences-related posts.

The presentation describes a large, complex project with a complete paperless manufacturing goal that supports release by exception. For those not familiar with regulated industries, regulatory bodies like the U.S. Food and Drug Administration (FDA) require that all exceptions in the manufacturing process be investigated and signed off before product can be released for sale.

Release-by-exception implies that the exceptions can be reviewed and addressed in real-time, not after the fact, which is typical for paper-based workflows. By moving to a paperless workflow, the number of exceptions can be reduced as the manufacturing rules are enforced in real-time. The business benefit is to reduce the time finished products are warehoused waiting for the exceptions to be addressed. From a financial perspective, this reduces inventory costs and increases inventory turnover.

The project included a DeltaV automation system, Syncade manufacturing execution system, SAP enterprise resource planning system, SmartLab laboratory information management system, and Maximo instrument asset management system. All were connected with the Syncade software to drive an electronic workflow process and final electronic batch record.

Christie and her co-presenter offer examples of manufacturing steps, role of electronic workflow, and how it ensures quality and/or expedites the review and release process. An example is the quality assurance (QA) review process. The electronic workflow enables presentation of the electronic batch record (EBR) in a checklist form for QA review. It ensures quality and/or expedites the review process by launching the notification for QA review in real time and providing a view that displays the relevant information in the familiar QA checklist format.

The presentation also shares the S88 (ISA-88) approach taken, specifically the bioreactor process control at the control system level and workflow connections at the MES (manufacturing execution system) level between the software applications mentioned above.

I won’t steal the thunder from the best part, lessons learned, other than to share one example of the importance of finalizing the vision and requirements early and documenting them. It’s critical for the success of large, complex projects to establish and connect this common vision with the project team and workflow stakeholders to move the project along and minimize rework.

If you’re looking for ways to optimize your process manufacturing workflows, you’ll want to attend this session on May 26 at 2:15pm.

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