Expects to Implement C3 SmartRoom Control Technology in Stem Cell Industry
By: Marketwire .
May. 19, 2011 09:25 PM
PITTSBURGH, PA — (Marketwire) — 05/19/11 — HWI Global, Inc. (OTCBB: IVTW), the Pittsburgh-based clean-room design builder, reports developing high-level Manufacturing Execution System (MES) software combining complete environmental control with real-time monitoring and reporting in accordance with GMP Guidelines and Federal statute 24CFR11. The MES software package is part of HWI’s patent-pending C3 SmartRoom Information Management Solution.
HWI’s MES system complies with 24 CFR Part 11 requiring electronic systems to discern invalid or altered records and secure, computer-generated, time-stamped audit trails. The system independently records the date and time of operator entries and actions that create, modify, or delete electronic records which do not obscure previously recorded information.
The Company recently completed two projects for Stemnion, Inc., a regenerative medicine stem cell firm. Acknowledging various world-wide regulatory bodies are continuously setting guidelines which require timely updates, HWI is keeping in step with the scientific developments and changing attitudes in society.
Deric A. Haddad, CEO, HWI Global explains: “Historically, GMPs have been used to establish quality standards for the manufacturing of pharmaceuticals and medicinal products to ensure drugs and vaccines have consistent quality. Current GMP guidelines are based on the standards that pharmaceutical and healthcare manufacturers have been using for decades. But, with the emergence of stem cell research, new questions have been raised about how to best maintain that quality.”
“Regenerative medicine therapies use different techniques — like tissue engineering. This can involve lab-grown or genetically modified cells — living cells — that cannot be implemented in the same way as a conventional medical product. A different set of standards, a more flexible but accurate validation system is required. Our C3 SmartRoom with the MES software is exactly what they need as it provides automated validation to support that their lab and process have remained in compliance. Whether it is regulatory compliance with the Food and Drug Administration (FDA), the European Medicines Agency (EMA), or any of the countries that use GMP guidelines provided by the World Health Organization, the C3 SmartRoom system is a global solution for validation in this growing, but very diverse, market.”
About HWI Global
HWI Global is a leader in clean-room design engineering and construction, servicing clients in the Life Science, Health Science, Nanotechnology, Microelectronics and Aerospace industries. HWI Global and its network of subject matter experts (SME) — from leading architects, engineers, facilities planners, and specialized installers — effectively design and construct the most state-of-the-art clean environments in a “turnkey” fashion.
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