GraphLogic Enterprise Systems Part 11 and GxP Compliant
Branford, CT – USA, January 23, 2007. GraphLogic Inc. announced today that its software applications built for biotechnology and pharmaceutical companies are fully compliant with CFR Part 11 and the applicable regulations.
The external audit, conducted by Dr. Sandy Weinberg and Carl Rockburne, evaluated all key elements of GraphLogic’s operations including authentication, electronic signature confirmation, software audit trails, data integrity, and documentation of best practices in software development. Dr. Weinberg, who has served as a regulatory compliance auditor to biomedical industries in relation to Part 11, GMP, GLP, and GCP for over twenty years, and also as an expert witness for the FDA, EPA, and international equivalents observed, “GraphLogic’s controls were well beyond the necessary requirements and guidelines for software companies.”
The audit was conducted in conjunction with the development and installation of a Service Center LIMS for Sequenom, Inc. Harry Stylli, Ph.D., President and Chief Executive Officer of Sequenom is pleased that GraphLogic exceeds the requisite compliance guidelines for software development. “Their system should enable Sequenom’s genetic analysis services unit to fully satisfy the regulatory requirements demanded by our customers,” stated Stylli.
Steven Gold, Ph.D., CEO of GraphLogic, acknowledged the company’s exceptionally high standards for creating and delivering software to its customers. “We are pleased with this external validation by industry experts,” announced Gold, “and we are delighted to be working with Sequenom to further demonstrate our capabilities.”
About GraphLogic Inc.
GraphLogic Inc. creates web-based custom systems with its proprietary technology – a codeless application builder. Customers see their applications come to life, over the web, as they develop. GraphLogic custom applications are built for change, keeping pace with business requirements. Customers operate in data intensive, high throughput and rapid growth production environments in the Life Sciences.
For more information about GraphLogic, please visit our website at www.graphlogic.com.
About Sequenom, Inc.
SEQUENOM is committed to providing the best genetic analysis products that translate genomic science into superior solutions for biomedical research, agricultural applications, molecular medicine and non-invasive prenatal diagnostics research, and potentially, clinical utility. The Company’s proprietary MassARRAY® system is a high-performance DNA analysis platform that efficiently and precisely measures the amount of genetic target material and variations therein. The system is able to deliver reliable and specific data from complex biological samples and from genetic target material that is only available in trace amounts. The Company has exclusively licensed intellectual property rights for the development and commercialization of non-invasive prenatal genetic tests for use with the MassARRAY® system and other platforms.
For more information on Sequenom, please visit www.sequenom.com.
