Ensuring digital image analysis in compliance with FDA 21 CFR 11

1st April 2013

Dr. Manfred Kässens reports on how image analytical software has been adapted to meet the demands of the regulation entitled FDA 21 CFR Part 11.

The FDA ­ the Food and Drug Administration for the United States ­ has issued a new regulation. It is entitled FDA 21 CFR Part 11 ­ electronic records, electronic signatures and 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 covered by FDA 21 CFR Part 11 deal with topics such as access control, Audit Trail capacity and data security.

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.

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

GxP and FDA 21 CFR part 11 compliance could not be realised using just software alone. What really makes for a complete solution fully compliant with FDA specifications is the validation, ease-of-use and system organisation based on the relevant procedural guidelines and SOPs (Standard Operating Procedures).

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Dr Manfred Kässens is with Soft Imaging System, Münster, Germany.





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