ATCC introduces CRMs for method validation and method-performance verification

ATCC announces the launch of Certified Reference Materials (CRMs), issued under ISO Guide 34 and ISO 17025:2005 accredited and ISO 9001:2008 certified laboratories. As a certified reference material producer, the combined accreditations demonstrate the highest level of quality assurance, accuracy and traceability for ATCC customers.

“They also provide the consistency needed for testing and calibration performed in ISO 17025 accredited laboratories.”

ATCC Certified Reference Materials are intended to be used to challenge assay performance, validate or compare test methods, and to establish sensitivity, linearity and specificity during assay validation or implementation.

"ATCC Certified Reference Materials are an important tool for method validation and method-performance verification," said Liz Kerrigan, Director, Standards and Certification at ATCC. "They also provide the consistency needed for testing and calibration performed in ISO 17025 accredited laboratories."

"ISO Guide 34 accreditation represents an objective measure of confidence in the consistency and quality of ATCC reference cultures. It expands ATCC's ability to produce internationally recognized standards for biological research and development, including Certified Reference Materials," said Rosemarie Pruden, PhD, Director of Quality at ATCC.

Under ISO Guide 34 accreditation, ATCC CRMs are qualitative standards that are tested to the highest level of quality control. The CRMs are:

  • Optimized for homogeneity and consistency from lot to lot
  • Verified using polyphasic characterization
  • Tested to a stated level of confidence, where appropriate

Detailed certificates of analysis are provided with CRMs. In addition, the serialized vials have up to a 5-year stability and the pedigree is traceable to the CRM seed lot.

"Our CRMs are part of our growing catalog of products that demonstrate excellence in establishing reference standards and executing products that reflect our expertise in quality management," said Raymond Cypess, PhD/DVM, CEO and President of ATCC.

The ATCC quality system ensures that the organization maintains the highest level of accreditations available in the industry---ISO Guide 34 Reference Material Producer, ISO 17025:2005 Testing Laboratory, and ISO 9001:2008 Quality Management System.

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