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Regulated Industries Success: Biopharmaceutical Company Achieves CGMP Compliance and Operational Excellence with Advanced Solutions
A biopharmaceutical firm poised for growth successfully transitions to in-house manufacturing, meeting CGMP compliance and boosting efficiency through cutting-edge solutions.
About
A commercially-established biopharmaceutical company, primed for substantial growth and product line expansion, sought a solution to achieve CGMP compliance while improving customer service and overall profitability.
Challenge
As the company evolved its business model, transitioning manufacturing processes in-house to support expanding product lines and projected growth, they faced a critical challenge. Their 30-year-old legacy system proved incapable of meeting the regulatory, business model, and growth requirements essential for their success.
Solution
In the quest for FDA compliance and top-tier solutions, the customer selected a comprehensive package that included vital elements like vendor/item controls featuring effectivity date management, vendor audits, and non-conformance investigations. This solution also encompassed advanced production capabilities, incorporating precision weighing and dispensing features, IoT data integration, enhanced e-signature capture, and comprehensive batch reporting. Furthermore, it expanded material management capabilities, facilitating lot visibility and control, shelf life and re-test management, and product labeling controls.
Results
Through the implementation of Merit for Life Science, the customer successfully realized its goal of in-house commercial product manufacturing, harnessing leading-edge transdermal technology for various serious diseases. The organization now leverages Merit for Life Science to achieve full regulatory compliance while simultaneously increasing efficiency and productivity on a fully digital platform.