Digital image analysis in compliance with the FDA 21 CFR 11 specifications

16-Jan-2003

In conjunction with BioMedion of Göttingen, Germany, Soft Imaging System has adapted the analySIS® image-analytical software to meet the demands of the regulation entitled FDA 21 CFR Part 11. Via the seamless integration of the BM-windream document management System by BioMedion into analySIS®, the image-analytical 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.

BW-windream by BioMedion is a patented Document Management System (DMS) and it meets the FDA 21 CFR Part 11 specifications. This is the DMS offered by analySIS® FDA. It does not require a separate user interface as it is fully integrated into the MS 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.

All GxP-relevant data generated by the user in analySIS® FDA (images, sheets, graphics, graphs, reports, etc) are saved in formats approved by the FDA - images as TIFF files; reports as PDF's and meta information (or meta data) from the analySIS database are saved in the XML format. This fulfills important FDA requirements regarding long-term stability and transferability of data.

Version management as offered by analySIS® FDA ensures that all relevant alterations made to data and images are recorded - no exceptions - making all modifications fully traceable. Version management controls file creation and file management as well. All versions of a file remain accessible at any time. And any versions previous to the most current one are write protected.

analySIS® FDA's Audit Trail fulfills FDA specifications with regard to the documentation of changes made to files. All system operations, all file movements and any other operations are automatically listed - including the date, time, user name and the operations executed. Audit Trail entries cannot be edited. At the mere click of a button, you view the complete history.

Only authorized and trained personnel have access to this system - which is protected via access control (user name and password).

https://www.chemeurope.com/en/news/18806/digital-image-analysis-in-compliance-with-the-fda-21-cfr-11-specifications.html