Yesterday we highlighted advancements in exception management technology for pharmaceutical and biopharmaceutical manufacturers. Exception management is one element in an electronic batch record (EBR).
Other elements for the EBR which also have high data integrity requirements include equipment management, material management and batch record process flow and recipe management.
In a PharmTech article, Making the Move to Electronic Batch Records, Emerson’s Kevin Stembridge and Michalle Adkins share how EBR helps manufacturers with compliance, error reductions, traceable actions, and automatic documentation creation.
The EBR records the critical manufacturing steps including:
…data associated with operators, the manufacturing process, equipment, materials, and supplies. It can also include data from laboratory information management systems (LIMS), enterprise resource planning (ERP), process control systems (PCS), and more.
Electronic batch records help meet regulatory requirements such as the U.S. Food & Drug Administration’s 21 CFR Part 11. They also improve the manufacturing process with:
…improved data integrity and accuracy, streamlined processes, and efficient operations. Optimizing these processes yields improved resource management, improved inventory management, and reduced material losses…
Manufacturing execution system (MES) technology, such as Syncade MES, does not solely make for a successful transition from manual record keeping to EBR. Project success requires proper evaluation, planning and implementation for:
- People (organization culture)
- Business processes
Changing culture and processes needs a thorough evaluation of:
…how people work with each other, how data are used, how data integrity is maintained, and how processes are implemented.
Management-led change is imperative.
Management must communicate the overall organizational direction and why this change is important. Plant-floor personnel will therefore understand why changes are occurring, and they will recognize the value of the changes in their daily responsibilities.
Cross functional participatory workshops help in arriving at the important decisions and building the implementation plan. These workshops help identify key performance indicators, needed organizational changes, set expectations and align everyone on the vision and path to achieve it.
The control system and manufacturing execution system applications must support the data integrity requirements for the regulatory bodies involved in the production of the products being produced. The data integrity requirements include user and workstation management, electronic signatures related to product quality, and disaster recovery for the systems.
Read the article for more on the technology and architectures required for high-integrity electronic batch records and the benefits once the project is successfully implemented and culture and work processes fully transitioned.
Learn more about the role of MES in electronic batch records in the Manufacturing Execution Systems section on Emerson.com. You can also connect and interact with other MES and pharmaceutical & biotech industry experts in the Operations Management and Life Sciences groups in the Emerson Exchange 365 community.