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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.
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.
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