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archiveFDA - 21 CFR Rule 11 compliant software
Key features
  • Open document management system (compliant with FDA 21 CFR Part 11)
  • Client-Server capable
  • Audit Trail capability
  • Access control
  • Versioning
  • Data exchange
  • Electronic signature via SmartCard encryption
  • Long-term archiving
The Food and Drug Administration (FDA) of the United States has issued a regulation entitled FDA 21 CFR Part 11 - electronic records, electronic signatures - defining its guidelines for governing the recording and administration of electronic data as used for research, development and production purposes. Companies using computer-supported systems wishing to market their products in the United States are legally obligated by this regulation to document and validate functionality, reliability, reproducibility and transferability with regard to electronic data management.
The 'heart' of FDA 21 CFR Part 11 has to do with topics such as access control, audit trail capability and data security. Those in the pharmaceuticals, bio-technology and medical technology fields are on the look-out for cost reduction, accelerated development processes and increased productivity. These would be consequences resulting from the realization of the contents of this regulation. One way of attaining them is via speedier access to documents.
Description Specifications
archive FDA is a perfect and repeatedly validated solution for fulfilling this FDA regulation regarding image analysis with features like audit trail functionality, Windows-based user management, saving of all documents generated in iTEM / Scandium and/or data saved in your database, versioning, long-term archiving, data security, validatability and electronic signaturing.
Integrated solution for compliance with FDA 21 CFR Part 11
archive FDA uses the patented Document Management System (DMS) BW-windream by BioMedion which has been validated specifically for the requirements of FDA 21 CFR Part 11. This system does not require any separate graphical user interface as it is fully integrated into the MS Windows operating system. The DMS functionality is made available to client computers in the same way as a special network drive. All functions typical of a DMS such as querying, versioning, history or an electronic archive with access to optical mass storage are all directly available to the user. In addition, the open DMS system concept makes it possible to hook up other equipment and applications. This means that using archive FDA and BM-windream together provides you with an integrated system for managing all lab data. And in a way fully compliant with FDA 21 CFR Part 11.
Audit Trail capacity
The Audit Trail as offered by archive FDA fulfills the FDA requirements with regard to documentation of file changes. All system operations, all file movements and other actions are automatically recorded with the date, time, user name and the action executed. Audit Trail entries cannot be manipulated. A simple click of a button and you have the complete history displayed.
Access control
Only authorized and trained personnel have access to the system - secured with access control using user name and password. From the very start all authorized persons have direct and easy access to relevant information. And all without additional expense or having to waste time waiting.
archive FDA's version management ensures that all relevant changes made to data and images can be reproduced fully without an iota of information missing. This version management also controls generation and management of files. All versions of a file are available at any time - however, all previous versions are write protected (ie, they cannot be modified).
Data exchange
All GxP-relevant data generated by the user in archive FDA (images, sheets, graphics, graphs, reports, etc) are saved in generic formats recognized by the FDA. Images are saved as TIFF files; reports as PDF's; and meta information from the iTEM / Scandium database is saved in the XML format. This means that important requirements of the FDA for long-term stability and data transferability are thus fulfilled.
Electronic signature
The electronic signature in archive FDA is done via a Smartcard encryption and thus guarantees an additional level of data security. The signature used by archive FDA is in fact a signature which is digital and which is legally valid under European law. This is particularly important when - besides the FDA 21 CFR 11 - GLP (Good Laboratory Practice) has to be followed as well, in compliance with national or OECD (Organisation for Economic Cooperation and Development) standards.
Long-term archiving
In conjunction with the BM-windream document management system, archive FDA ensures long-term archiving of all data generated during the accreditation process.
Integrated concept for validation and compliance
GxP (Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), etc.) and FDA 21 CFR Part 11 compliance cannot be put into effect with software alone. Only a successful synthesis of validation, ease-of-use and systems organization based on appropriate procedural rules and SOP's (Standard Operating Procedures) results in an all-encompassing solution that is fully compliant. Via the partnership with BioMedion, OSIS offers consultation, validation and training all from the same source alongside its integrated software and hardware solutions.
All images and data
Images and data produced by light, electron or scanning probe microscopes are read into archive FDA directly. More extensive processing and image analysis is conducted within the software. Images, sheets, graphics, graphs, reports, and so on considered relevant for certification are evaluated in archive FDA and deposited on the Windream server via the integrated database. All information in user-specific database fields is stored as file records in the XML format on the Windream server. Whenever a record needs altering, it is checked out of the database while it is altered. After the record has been edited, a comment on that editing is automatically requested. Principally, anytime changes are made, a new version is generated - documented by an entry into the history listing user, date and time.
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