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Pharmaceutical companies operate in one of the most highly-regulated industries in the world. As most companies sell to a global market they have to manage compliance with an increasing set of regulations around the world - most importantly the FDA regulations, such as FDA 21 CFR Part 11, if the U.S is a target market. A failure to comply or even a drug re-call can have disastrous consequences for the business. The need for proper traceability of business transactions - the ability to correctly reproduce who has executed the transaction and at what time - is one of the key requirements of the FDA regulations.

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Format:PDFSize:534 KB
Date:May 2009
Pages:8

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