Responding to customer requests to unify track-and-trace across discrete and batch hybrid environments, Rockwell Automation recently rolled out a new version of its PharmaSuite manufacturing execution system (MES) software that the company says will bridge that gap.
Version 7.0 of the PharmaSuite software addresses the growing market in medical device and pharmaceutical manufacturing that require both batch and discrete assembly processes.
“Discrete and batch processes have historically required separate track-and-trace systems,” says Martin Dittmer, Rockwell Automation’s PharmaSuite product manager. Consolidating these traditionally disparate processes into a single system can reduce implementation, training, and maintenance costs, as well as increase agility as manufacturers prepare to comply with impending product-traceability regulations, Dittmer says.
In addition, PharmaSuite v7.0 includes streamlined usability patterns at the workstation level allowing assemblers to identify the correct components and view assembly instructions with the scan of a bar code. The software adds order-management and electronic device history record (eDHR) support to ensure that the assembly process for every medical device is tracked and documented.
New dashboard capabilities allow end users to filter product criteria by 20 different attributes, including exceptions, orders and batches. Quality-assurance personnel, for example, can use the filter to instantly sort through thousands of devices and view only those with exceptions. Once created, the customized filters can be saved and stored for future use.
The latest version builds upon PharmaSuite v6.0, announced last October, which added in-process control checks through recipe modeling capabilities that benefit the highly-regulated life sciences industry.
To that end, the track-and-trace theme continues with last month’s additional announcement of Rockwell Automation’s new holistic serialization software—which sits on top of PharmaSuite MES—and leverages the Microsoft Azure cloud-computing platform to connect and share data.
Designed for anti-counterfeiting regulatory compliance, the serialization capability has interoperability across all enterprise and control system levels of the ISA-95 data model, the company says, solving the integration challenges of traditional “black box” serialization systems created at the machine or enterprise levels.
Data is shared between the plant floor, the enterprise, the supply chain partners, the retail point-of-sale, and eventually even the customer, company officials say, providing real-time visibility down to the individual saleable unit.
The holistic serialization software uses a GS1 Electronic Product Code Information Services (EPCIS)-certified system from Covectra Inc., providing global serial-number generation and supply-chain event repository data management with benefits that include downstream track-and-trace, consumer authentication, patient adherence, and patient outcome monitoring.
Life sciences – as well as many food, beverage and consumer packaged goods companies-- must implement or upgrade track-and-trace systems to meet the growing number of serialization regulations worldwide. Rockwell Automation’s new offering provides the required compliance, but also helps manufacturers achieve commercial and business benefits, the company says.
“In pharma, traceability is key,” says Khris Kammer, Rockwell Automation’s commercial programs manager. “We’ve done this for years, but now we have much more granularity.”