Emerson, Decision Management partner to serve FDA-regulated applications
Austin, TX; Bradenton, FL—To offer production management expertise, cross-platform integration services, compliance workflow software and life-cycle services, Emerson Process Management and Decision Management International (DMI) recently formed an alliance to extend both companies' automation technology and services in the pharmaceutical and biotech industries.
Austin, TX; Bradenton, FL— To offer production management expertise, cross-platform integration services, compliance workflow software and life-cycle services, Emerson Process Management
Emerson and DMI plan to pursue FDA-regulated automation business worldwide through joint sales, product development and marketing efforts. The combined solutions offering will deliver advanced process automation and workflow compliance applications, and will integrate process and manufacturing execution information to help manufacturers reduce product cycle times, realize cost savings and comply with cGxP practices.
As part of their alliance's resale and systems integration section, Emerson will combine its pharmaceutical industry expertise, engineering resources and project management capabilities, as well as its PlantWeb digital plant architecture, with DMI's Web-based software and service solutions, Regulus. The companies will also participate in a joint development project to integrate Regulus with Emerson's DeltaV digital automation, which is PlantWeb's host system.
'This alliance will address one of the biggest challenges facing pharmaceutical and biotech enterprises: information flow between the process and manufacturing management,' says Jim Nyquist, president of Emerson's Process Solutions division 'Managers and production personnel often work in silos, and typically, information systems work independently as well. The integration of Regulus software and the DeltaV system represents a critical component of Emerson's automation strategy, creating a seamless manufacturing environment that enables the enterprise to link its process automation with compliance and workflow systems. "The alliance will also deliver innovation to coordinate recipe execution between the process equipment and the manufacturing execution operations, including the integration of electronic operator work instructions.'
Frank Grywalski, DMI's chairman and ceo, adds that, 'We welcome the opportunity to work with a quality partner and market leader, such as Emerson Process Management. This partnership will enable us to work together to provide FDA-regulated manufacturers with an unparalleled solution. The combined Regulus and DeltaV offering will be unequaled in the industry; presents a great value proposition for pharmaceutical and biotech enterprises; and will translate into significant bottom-line savings, while reducing the burden of regulatory compliance.'
Regulus' integrated, Web-designed enterprise suite of applications for paperless cGxP manufacturing is based on a zero-client, Microsoft .Net architecture. The suite includes applications for document management; cGxP document life cycle control and archiving; electronic recipe authoring; recipe and materials management; equipment and calibration records tracking; personnel training and development records management; weighing and dispensing operations control; manufacturing order management; and electronic batch records.
The combination of Regulus and PlantWeb will allow FDA-regulated enterprises to quickly implement the entire suite or specific software applications that enable compliance with 21 CFR Part 11 record and signature rules and cGxP practices. When integrated with intranet, ERP and LIMS systems, this combined offering can extend the value of these investments.
Control Engineering Daily News Desk
Jim Montague, news editor