Scimagix's Image Informatics Platform, SIMS, Supports French Data Security Regulations - CNIL.

Business Editors/High-Tech Writers

SAN MATEO, Calif.--(BUSINESS WIRE)--March 4, 2003

Scimagix Committed to Enabling Regulatory Compliance for Global

Customers

Scimagix(TM) Inc., the pioneer of enterprise image informatics solutions for pharmaceutical and biotechnology research and development (R&D), today announced support for requirements pertaining to confidentiality of patient records and information as mandated by the French Commission Nationale de l'Informatique et de Libertes (CNIL). Image informatics is the integration of valuable image and non-image data to better understand biology and make more informed decisions in drug discovery and development. CNIL is an independent administrative authority instituted by the French government to guarantee that data processing in the public sector is conducted with respect to personal privacy.

Scimagix's support of CNIL requirements is in addition to its support of U.S. regulatory requirements including Food & Drug Administration (FDA) regulations for electronic records (21 CFR Part 11), as well as GxP standards for Good Laboratory Practice and Good Manufacturing Practice. CNIL requirements are the French counterpart of the U.S. Heath Insurance Portability and Accountability Act (HIPAA) as it pertains to confidentiality of patient records and information during the course of pharmaceutical testing.

"Drug discovery and development is increasingly an international endeavor, and Scimagix has always maintained a global perspective," said Robert Dunkle, president and CEO, Scimagix. "Our multi-national pharmaceutical customers benefit from an image informatics system that facilitates improved collaboration among researchers in a regulatory environment. Global pharmaceutical companies have been quick to recognize that regulatory compliance is critical to their reaping the value of image informatics for accelerated drug discovery and development."

Scimagix enables regulatory compliance for global customers through its Scientific Image Management System (SIMS(TM)) in combination with the SIMS(TM) Regulatory Module. This enterprise-wide, multi-site software system, tailored to image data, allows scientists to search, mine, analyze and share results. In addition to CNIL requirements, Scimagix will continue to incorporate additional regulatory requirements as necessary to support its global customers.

"Scimagix is committed to enabling international regulations in addition to U.S. regulations so that our customers can implement a single, centralized image informatics solution across their entire global enterprise," said Janet Smith, Ph.D., vice president of quality and regulatory processes, Scimagix. "Pharmaceutical companies can be assured that the Scimagix solution will support all the global regulatory requirements entailed in bringing a drug to market successfully."

Companies seeking to comply with regulatory requirements are discovering that image data poses a unique set of challenges. Images are routinely modified in the course of research, and require sophisticated software to retain the original data and the audit trail required by FDA regulations to document subsequent modifications. Using SIMS, scientists can archive both new and legacy image electronic data in a searchable, Web-based system that retains original materials and all subsequent changes.

An enterprise-wide system, SIMS facilitates ongoing collaboration within multinational companies. For example, a research group at a major pharmaceutical company conducting histology-based research at several, geographically dispersed locations can use the SIMS solution to replace the practice of e-mailing image results across corporate networks and at the same time ensure the image data is viewed in the appropriate experimental context. Multiple researchers can use the database simultaneously, retrieving images for multiple purposes. Improved collaboration has improved productivity: researchers in different countries working on the same or similar projects can share image data while complying with local regulatory requirements.

Availability

Support for French CNIL requirements is included in SIMS 2.0 and the SIMS Regulatory Module, commercially available for general installation and upgrade. In addition to the products, Scimagix offers services to satisfy validation requirements of regulatory compliant systems. These services can be employed to validate the operation of SIMS 2.0 and the Scimagix Regulatory Module in the customer's operational environment and includes qualification scripts to verify that the systems adhere to regulations. Scimagix services substantially reduce the time needed for customers to achieve compliance and supports a validation protocol required to address FDA inspections.

About Scimagix Inc.

Scimagix(TM) Inc., based in San Mateo, Calif., is the leading provider of image informatics solutions for pharmaceutical research and development (R&D). Its flagship SIMS(TM) (Scientific Image Management System) platform, an Oracle(R)/Web-based database management system, utilizes open architecture to deliver a comprehensive and searchable image database. Image informatics technology integrates valuable image and non-image data into SIMS, allowing scientists to search, mine and analyze all results. ProteinMine(TM), running on top of SIMS, supports high throughput analysis and mining of image data with proprietary visual content search technology, dramatically increasing the accuracy and productivity of R&D processes. Scimagix serves most of the top 15 pharmaceutical companies including Pfizer Global R&D, Hoffmann La Roche and Eli Lilly & Co. For more information about Scimagix, please visit www.scimagix.com/

For more information about CNIL and its requirements, please visit http://www.cnil.fr/.