January 28, 2010 - Elan Software, a Siemens Business, unveils extended XFP MES version dedicated to Life Science industries.
XFP and SIMATIC IT have joined to offer Life Science industries with extended MES solutions. Siemens established worldwide MES Center of Excellence.
Elan Software Systems, a Siemens Business dedicated to MES software for life sciences industries, today announced the availability of an extended XFP MES version integrated with SIMATIC IT, the Siemens flagship MES platform. The extended XFP MES now provides the Life Sciences Industry with a complete and modular FDA-regulated MES portfolio including Electronic Batch Record, Weigh & Dispense, Historian, OEE, Statistical Process Control, Detailed Scheduling, LIMS and Manufacturing Intelligence.
Life Sciences: Extended MES with full system interoperability available today
XFP and SIMATIC IT, the MES solutions component of the wider Siemens Software portfolio have joined to provide an MES platform that truly meets the requirements of Life Sciences manufacturers. The extended XFP MES solution provides production visibility and control throughout the enterprise by optimizing the production cycle from raw material delivery to end product shipment in compliance with 21CFR part 11 and ISA 88/95.
As of today, XFP electronic Batch Record and Weigh & Dispense are connected with SIMATIC IT complementary products including Historian, OEE, Statistical Process Control, Detailed Scheduling, LIMS and Manufacturing Intelligence. The extended XFP MES offering also interacts seamlessly with the Siemens automation layer enabling manufacturers to benefit from Totally Integrated Automation. All MES modules are available as stand alone modules or as part of a complete MES Offering, providing great adaptability to Life Science requirements.
Worldwide MES Center of Excellence (CoE) for Life Sciences
Siemens recently established its worldwide MES center of excellence for Life Sciences industries in Toulouse, France. A team of more than 70 Life Sciences experts, with experience of over 200 MES deployments across pharmaceutical, biotech, cosmetics, CMOs, and fine chemical plants, assists manufacturers in their MES initiatives. The Siemens MES team worldwide includes over 800 experts in a variety of industries.
MES deployments in Life Sciences specifically require the validation of the software systems and this can represent a significant cost if not managed efficiently. The Siemens MES center of excellence for Life Sciences benefits from a comprehensive expertise in the validation process, minimizing validation cost and accelerating MES deployments for our customers.
- A category IV MES software according to GAMP V guideline
Siemens MES solutions are configurable software products, which translates into easy roll-outs, deployments and upgrades.
- Validated software platform
Operational Qualification (OQ) and Installation Qualification (IQ) are performed at the supplier level prior to software delivery, ensuring a stable and robust software platform. Life Sciences manufacturers benefit from a validated MES software solution with reusable documentations, including test supports, change control and specifications. There is no need on site to duplicate the OQ/IQ tests, reducing cost and time efforts.
- State-of-the-art assistance for efficient project validation
The Quality Assurance of the Siemens MES Center of Excellence provides the required level of assistance for efficient project validation. Validation services include risk analysis, validation plan, verification strategy, test coverage as well as master documentation and change management.
The extended XFP MES solution together with Siemens MES Center of Excellence are true commitments of Siemens willingness to provide the right MES solutions dedicated to Life Sciences including software and services.
