Medical Devices

GxP Training: Its Vital Role in Regulated Industries 

by | Jul 30, 2024 | , , , ,

GxP training isn't just a checkbox; it's the key to safeguarding your life science supply chain, protecting patients, and securing your company's future. It's 3 AM. In a pharmaceutical plant, a team works diligently to produce a life-saving drug. Suddenly, a critical error occurs because a new hire, overwhelmed and undertrained, mishandles a key process.   This scenario isn't just a nightmare; it's a reality that many in the life sciences industry face. In highly regulated industries like pharmaceuticals, biotech, and medical devices, the stakes are incredibly high. Effective training isn't just a box to tick; it's a lifeline that ensures safety, compliance, and operational excellence.  The Crucial Role of GxP Training Management  Training management in regulated...

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Lessons from 483s: Essential Strategies for Medical Device Manufacturers 

by | Apr 3, 2024 | , ,

Streamline CFR Part 820 compliance for medical devices. Merit for Life Science tackles CAPA, complaints & training for smoother FDA inspections. Introduction As a medical device leader, ensuring FDA compliance is paramount. It safeguards product safety, patient well-being, and your business from costly citations. However, navigating the complexities of FDA regulations can be daunting. Merit for Life Science simplifies this process.  The Challenge: Avoiding Costly FDA Citations  A closer examination of Form FDA-483 or FDA 483 Warning Letters reveals the most common reasons medical device manufacturers are issued a 483. Since 2015, 38% of citations (4,568 to be exact!) stemmed from just two areas:  21 CFR Part 820.100(a): Corrective and Preventive Action (CAPA)...

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Enhancing Collaboration in Regulated Industries: The Cloud Advantage

by | Feb 8, 2024 | , , , , , ,

Collaboration is the cornerstone of success in today's fast-paced business world. This holds particularly true for regulated industries like medical devices and biopharma, where efficiency, compliance, and quality control are paramount. Cloud platforms, such as Microsoft Azure with Merit Life Science for Dynamics 365 have revolutionized collaboration by providing secure and compliant environments for data sharing and real-time decision-making. The ability to streamline approvals, enhance transparency, and reduce operational uncertainties not only benefits the organizations but also elevates the customer experience. Streamlined Approvals and Compliance Consider a scenario where a contract manufacturer (CDMO) needs customer approval to proceed with a critical production batch. The data...

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How Life Science CDMOs are Using Cloud Computing to Create Differentiation

by | Jan 25, 2024 | , , , , , , ,

Contract development and manufacturing organizations (CDMOs) are experiencing new entrants and capacity expansion, leading to the need to create and maintain differentiation in service offerings to stay competitive. With change comes opportunity, and the strategic implementation of digital infrastructure is crucial for staying competitive. In this blog, we'll explore four reasons why CDMOs are increasingly moving to cloud applications to run their enterprise business and the benefits of cloud applications.  Capacity Expansion Differentiation and Competition  People and Collaboration  Quality, Speed, and Confidence Capacity Expansion  Until recently, biopharma contract development and manufacturing faced a significant capacity shortage. Procuring contract development...

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Optimizing Inventory Management in Pharma and Biotech

by | Jan 18, 2024 | , , , ,

In this four-part blog series, we’ll explore how Merit for Life Science optimizes critical business processes for pharmaceutical and biotech companies. See our other blogs on inventory splitting and sub-batching, weighing and dispensing, and controlling storage conditions.   Controlling inventory management processes is important in any industry but critical for pharmaceutical and biotech organizations. Using an enterprise resource planning (ERP) platform helps these organizations optimize costs, investments, and product safety.    Merit for Life Science is a cloud-first ERP system that was purpose-built for pharma, biotech, and medical device manufacturers. Built on the Microsoft Dynamics 365 platform, Merit for Life Science provides tools that these companies can use to...

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