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 company decided to pursue formal certification to expedite supplier qualification by its clients, especially those in the established medical device sector and in the newly thriving BioTech sector. "This milestone is a culmination of our efforts to continually improve our quality system to better match the needs of our product development and validation testing activities," adds Wenrich. "The certification promotes efficiency when our customers are trying to qualify us as an approved supplier since it is a well-accepted industry benchmark."
Don Hurd, Realtime V.P. Quality and Validation Services, adds, "The ISO certification lets our customers know that we have a quality management system necessary to consistently meet customer and regulatory requirements applicable to medical devices and other regulated industry services." This is especially important to BioTech innovators that may not be completely knowledgeable about quality system practices in what is becoming a more regulated manufacturing environment.
Marlo Mravec, Realtime Director of Regulatory and Consulting Services, concedes that the BioTech industry has developed a need for "sophisticated product design tools such as manufacturing process qualifications in the form of IQ/OQ/PQ driven from established requirement specifications which result in measurable outcomes."
Compliance to ISO 13485:2003 assures Realtime customers a committed and trusted product development and validation testing partnership whether the target product is regulated by FDA, FCC, UL, or FAA.
About The Realtime Group - Realtime specializes in the design,
commercialization, and validation testing of electro-mechanical, software
intensive products and processes for the regulated industries including
medical devices, biotechnology, and industrial control systems. Visit
http://www.TheRealtimeGroup.com or call toll-free at 866-298-9205.
The Realtime Group
(972) 985-9100 office
(214) 893-7558 cell
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|SOURCE The Realtime Group|
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