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How to Avoid Data Integrity Disasters in Your Manufacturing Network

In cGMP, compliance, pharmaceutical, risk management by Alicia Cheung1 Comment

Lachman Consultants says that pharmaceutical manufacturers can establish a competitive advantage by preventing questions about their product quality data from disrupting current and future revenue. In recent years, data integrity shortcomings identified during GMP inspections have cost firms dearly. In some cases, the financial impact has run into the hundreds of millions of dollars. Despite the risk, many manufacturers do not seek help with data integrity compliance until there is a problem. By then, it may be too late to avoid an impact on profitability. For this reason, Lachman Consultants urges pharmaceutical companies to establish a competitive advantage by taking a proactive approach to data integrity assurance.

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Understanding the Hidden Costs of Weak GMP Documentation and the Return on Investment for Strong GMP Documentation

In biomanufacturing, business, Generis, generis group, manufacturing, pharmaceutical, production efficiency by GenerisLeave a Comment

In your experience, when an organization has invested in proper documentation, what have the results been like? The results have been tremendous! We’ve seen organizations move away from poor compliance and low morale toward a quality mindset with excitement for innovation. We’ve opened career paths for promising writers who love challenge and have a desire to help patients through strong GMP documentation. Our clients have demonstrated returns on investment for our projects by lowering documentation-based costs, reducing turnaround times, reducing documentation-based errors, and shortening regulatory filing times. Documentation comes off the critical path for the first time! Lastly, we’ve seen our projects serve as a springboard for further innovation and enhancements. In a nutshell, our best results have been realized when GMP documentation is embraced as an opportunity and powerful mechanism to help companies advance new therapies for their patients. To learn more about GMP documentation, check out the ebook by Bulletproof below! 

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