PLANO, Texas, June 12 /PRNewswire/ -- The Realtime Group (http://www.TheRealtimeGroup.com) announced today that it has received ISO 13485:2003 certification for its Quality Management System; the full scope covers design, prototyping, and testing services in Software Engineering, Embedded Microprocessor Systems, Safety and Risk Analysis, and Verification and Validation. The scope also covers Project Management and System Architecture Development.
"We've experienced that the BioTech industry today is at about the same maturity level as the medical device industry was 10 years ago. The science is awesome, however moving from the laboratory to the commercial manufacturing production processes is a huge leap for many innovative companies. Many of those companies inventing the science side don't yet understand the increasing regulatory scrutiny that is building as the industry grows. Baseline principles like Good Manufacturing Practice (cGMP), Good Documentation Practices (GDP), Risk Assessments per ISO 14971, chain of custody processing, and software/process validations which are now so familiar to the medical industry through enforcement actions by the FDA are still not being sufficiently cultivated within the BioTech sector," says Marshall Wenrich, Realtime Group President.
The Realtime Group assists innovators with mundane tasks of documenting risk analysis, validation testing, and other requirements for regulatory submissions and lean manufacturing operations. This kind of "knowledgebase rental" is more than just outsourcing, it can provide a significant acceleration to the BioTech company's own internal capabilities and understandings of the regulated marketplace. The true cost of ignoring these lessons are evident from almost daily headlines announcing recalls of tainted food products.
A well-structured quality system was always a cornerstone for Realtime
from day one but the c
|SOURCE The Realtime Group|
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