Case Study

Specialty Pharma Connects Content Management And Regulatory Compliance

Source: Dassault Systèmes Americas
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A European specialty pharmaceutical business was faced with increasing pressure on costs and margins. The company was looking for a more efficient and effective way to manage GxP-controlled documents such as standard operating procedures (SOPs), policies, work instructions, forms and templates. Project challenges included the necessity of rolling the new system out across numerous global sites currently operating with diverse, paper-based document management systems with variable document formats; inconsistent levels of control; no consolidated, end-to-end governance framework for managing metadata; and different ways of handling history data (some documents with up to four previous IDs and version iterations). In addition, with a view to improving regulatory compliance, the company needed to ensure full compliance with 21 CFR Part 11 regulatory requirements.

Read how the company deployed a fully integrated, closed-loop document management system that also addresses the quality and compliance requirements of regulatory bodies.

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