Both FDA regulations and ISO quality standards require companies to establish a system for document control that is electronic in order to ensure product quality and safety.
A document control software system ensures that production processes are all pre-approved, and that changes are restricted to authorized personnel and tracked for future review. Despite the importance of document control and document management, many companies continue to rely on paper-based or paritally electronic system for document control. These systems are plagued by inefficiency and errors that could cause FDA-483 citations or ISO nonconformance.
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