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FDA compliance for the life sciences

by Microsoft Corp.

This white paper by Microsoft Corp. defines compliance and its impact on companies in regard to risk and opportunity, focusing on the role of information technology. The role of technology providers and the degree of automation implemented in the company are critical success factors. Companies need to adopt a strategy that balances the trade-offs of risk and cost, while satisfying the needs of the market, the Food and Drug Administration and shareholders. This white paper discusses areas directly impacted by compliance in the production arena including procurement, inventory, manufacturing, quality and sales order processing. It also discusses the impact of compliance on information technology systems such as security, procedures, information storage and auditing.

Published: 2003
Format: PDF
Length: 16 pages
Type: White paper
Language: English
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