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"We've experienced that the BioTech industry today is at about the samematurity level as the medical device industry was 10 years ago. The science isawesome, however moving from the laboratory to the commercial manufacturingproduction processes is a huge leap for many innovative companies. Many ofthose companies inventing the science side don't yet understand the increasingregulatory scrutiny that is building as the industry grows. Baselineprinciples like Good Manufacturing Practice (cGMP), Good DocumentationPractices (GDP), Risk Assessments per ISO 14971, chain of custody processing,and software/process validations which are now so familiar to the medicalindustry through enforcement actions by the FDA are still not beingsufficiently cultivated within the BioTech sector," says Marshall Wenrich,Realtime Group President.
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The Realtime Group assists innovators with mundane tasks of documentingrisk analysis, validation testing, and other requirements for regulatorysubmissions and lean manufacturing operations. This kind of "knowledgebaserental" is more than just outsourcing, it can provide a significantacceleration to the BioTech company's own internal capabilities andunderstandings of the regulated marketplace. The true cost of ignoring theselessons are evident from almost daily headlines announcing recalls of taintedfood products.
A well-structured quality system was always a cornerstone for Realtimefrom day one but the company decided to pursue formal certification toexpedite supplier qualification by its clients, especially those in theestablished medical device sector and in the newly thriving BioTech sector."This milestone is a culmination of our efforts to continually improve ourquality system to better match the needs of our product development andvalidation testing activities," adds Wenrich. "The certification promotesefficiency when our customers are trying to qualify us as an approved suppliersince it is a well-accepted industry benchmark."
Don Hurd, Realtime V.P. Quality and Validation Services, adds, "The ISOcertification lets our customers know that we have a quality management systemnecessary to consistently meet customer and regulatory requirements applicableto medical devices and other regulated industry services." This is especiallyimportant to BioTech innovators that may not be completely knowledgeable aboutquality system practices in what is becoming a more regulated manufacturingenvironment.
Marlo Mravec, Realtime Director of Regulatory and Consulting Services,concedes that the BioTech industry has developed a need for "sophisticatedproduct design tools such as manufacturing process qualifications in the formof IQ/OQ/PQ driven from established requirement specifications which result inmeasurable outcomes."
Compliance to ISO 13485:2003 assures Realtime customers a committed andtrusted product development and validation testing partnership whether thetarget 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, softwareintensive products and processes for the regulated industries includingmedical devices, biotechnology, and industrial control systems. Visithttp://www.TheRealtimeGroup.com or call toll-free at 866-298-9205.
This release was issued through eReleases(TM). For more information,visit http://www.ereleases.com.Contact: Lisa DeLucia
