Glossary Item

In generic terms, electronic Records management is the management of documents and records in electronic form in a controlled manner. This can go under many names – digitizing the business, document management, document control and others.

In FDA regulated industries, there are specific regulations governing the methods, security and retention time for specific documents – particularly those concerned with safety, testing, or quality.

WEBSITE:
       http://www.fda.gov/ora/compliance_ref/part11/dockets_index.htm

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