CPSA Digest 2002

Proceedings -Wednesday, October 9, 2002

WeOC13

Archiving Electronic Records to Enhance Compliance with 21CFR Part 11

The CyberLAB Knowledge Engineering System was developed by Scientific Software, Inc. in response to the ever increasing data explosion, particularly in the regulated industries. CyberLAB employs industry standard technologies including tools from Microsoft and Adobe to create an electronic library of information created by the enterprise. Files, both human and machine readable, are automatically placed into a safe and secure repository. Key metadata and indices are created and stored in a database, and the files are finally placed in a permanent archive, all under the auspices of 21 CFR Part 11 compliance regulations.

The first figure illustrated is the CyberLAB interface that is accessed through the Internet Explorer web browser. This home page allows users with the correct access privileges to search for, open and/or retrieve files, examine file properties, edit the folder properties and do all administrative activities for which privileges have been granted. Since the CyberLAB product is totally web-based, there are no executables required on the clients, making system validation less complex.

The second figure illustrates the file properties page in CyberLAB and demonstrates an example of the type of metadata extracted from instrument files, in this case a chromatography file that is placed in the database and becomes the information that is searchable. Also visible on other tabs on this page are general properties, full text indexing of PDF and EMX files where appropriate, electronic signature records and user-defined key information.

CyberLAB is a completely scalable product that will give regulated companies the ability to share information across the enterprise, increase productivity, improve time to market and protect intellectual property while assisting the companies in compliance with the FDA regulation 21 CFR Part 11.

Company website: www.scisw.com/

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