JANUARY 15--In conjunction with BioMedion of Gottingen, Germany, Soft Imaging System has adapted its analySIS image-analysis software to meet the demands of US Food and Drug Administration (FDA) 21 CFR Part 11. Via the seamless integration of the BM-windream document-management system (DMS) by BioMedion into analySIS, the image-analysis software and hardware solutions of Soft Imaging System fulfill all regulatory demands with regard to electronic processing and archiving of data and images for the pharmaceutical industry and biotechnology fields.
The new regulation defines specifications for recording and managing electronic data in research, development, and production. All companies using computer-supported systems wishing to market their products in the United States are required to demonstrate and have functionality, reliability, traceability and transferability validated with regards to electronic data management. Substantial aspects of the regulation deal with topics such as access control, audit trail capacity, and data security.
BW-windream by BioMedion is patented and meets the FDA 21 CFR Part 11 specifications. It does not require a separate user interface, as it is fully integrated into the Windows operating system. Client computers access the whole range of DMS functions on a special network drive. All typical DMS functions such as searching, versioning, history, and electronic archiving (including optical bulk memory) are available to the user directly. The open DMS system concept also makes it possible to hook up additional devices and applications, which means that analySIS FDA and BM-windream together comprise an integrated system for lab data management in compliance with FDA 21 CFR 11.
For more information, see www.soft-imaging.net/eng/infodesk/pr/prarch_e.php.
