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Your regulatory department is only as effective as your Documentation Management. In the pharmaceutical industry, regulatory compliance hinges on effective documentation management. A regulatory department can only support buisness decisions effectively if they can quickly assess any change against the dossier. Key Points: Traceability and Transparency: Essential for audits and maintaining stakeholder trust. Documentation must be organized and accessible. Efficiency: Quick access to necessary documents speeds up business decisions. Document harmonisation allows easier change management. Risk Management: Proper documentation managment identifies and mitigates risks. Gaps in the data can be identified if the dossier can be viewed holistically. Knowledge Preservation: Captures crucial development insights, facilitating future innovation. Understanding the history of your dossier is essential for buisness continuity and change assessments. Learn from your past submissions. Investing in robust documentation management isn't just about meeting regulatory requirements; it's about leveraging information for competitive advantage and ensuring patient safety and product quality. #PharmaceuticalRegulation #DocumentationManagement #RegulatoryCompliance #regulatoryaffairs #pharmaceutical #gmp

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