New capabilities in MES software for life sciences offer enhanced DCS integration for biotech, API and other manufacturers and ease regulatory compliance
With Rockwell Software PharmaSuite 8.2, manufacturers gain enhanced DCS integration, support for manual scales and for assembly of equipment components with GMP life cycle management, as well as improved master recipe maintenance for ERP BOM changes. The new release also helps to ease 21 CFR part 11 regulatory compliance and is certified to run on Windows 10 clients.
“Release 8.2 builds upon previous DCS integration capabilities by adding two new system phases,” says Martin Dittmer, PharmaSuite product manager. “The new phases allow manufacturers to initiate a DCS control recipe to retrieve DCS reporting parameters into the PharmaSuite batch record. Together with existing DCS alarm-related system phases that let manufacturers include GMP-critical alarms from the automation layer within the batch record, PharmaSuite 8.2 now offers a highly mature DCS integration capability, particularly for biotech and API manufacturers.”
The latest release of PharmaSuite also improves on already its best-in-class weighing/dispensing capabilities. The new release supports configuration and maintenance of manual scales, meaning scales that are not connected to the PharmaSuite system. As Dittmer explains, “Typically, our customers want to take advantage of connected scales so they can retrieve weighing data automatically and unambiguously. In “brown field” deployments or other specific use cases, however, customers need operating scales that are not connected. These manual scales are now integrated into our standard workflow.”
Assembly of Equipment Components with GMP Life Cycle Management
Enhancements also include support for assembly of equipment components. “Within pharmaceutical production,” says Dittmer, “certain equipment is usually assembled from individual components before production begins. For example, a compactor may consist of different parts such as a hopper, multiple compactor roles and sieves. Each of those components needs to be maintained and tracked individually based on its own lifecycle, and recorded in an electronic logbook.”
PharmaSuite 8.2 now allows manufacturers to maintain assembly instructions that ensure correct assembly sequence and that each component is “fit for purpose”, e.g., required cleaning has been completed. In addition, PharmaSuite supports all kinds of projected disassembly use cases, including disassembly and reassembly in exceptional situations like equipment breakdown.
Master Recipe Maintenance for ERP BOM Changes
To improve master recipe maintenance in support of ERP BOM changes, a new feature in the PharmaSuite Recipe Designer eases the takeover of ERP BOM-related changes into new master recipe versions by semi-automatically adjusting material parameters of the recipe to speed the master recipe maintenance process significantly and reduce the potential risk of errors.
21 CFR Part 11 Regulatory Compliance
Finally, PharmaSuite 8.2 also helps to ease 21 CFR part 11 regulatory compliance with user access restrictions by automatically locking the execution client after a specified period of inactivity. Once PharmaSuite is locked, the operator must log in again to continue work.
Windows 10 Certified
PharmaSuite 8.2 is certified to run on Windows 10 clients.