Quality and Compliance

6 ERP “Must Haves” for Tracking Chain of Custody within the Autologous CGT Industry 

In the autologous* cell and gene therapy (CGT) industry, tracking the path from patient to product is not just a regulatory requirement; it's at the heart of patient safety and product integrity. An Enterprise Resource Planning (ERP) system plays a crucial role in this process.  *(Lonza does a nice job of explaining the difference between autologous and allogeneic cell therapies here.)   Here are six essential features an ERP system should possess to ensure a reliable chain of custody: Patient Data Management and Sample Control  Supply Chain Optimization  Storage Controls  Electronic Batch Records Real-time Tracking and Traceability   Dynamic Demand Forecasting  Patient Data Management and Sample Control  Patient sample control is the...

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How Life Science CDMOs are Using Cloud Computing to Create Differentiation

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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5 Critical Metrics That Can Make or Break a Biopharma’s Year

This week we look at five critical operational metrics that can make or break a biopharma manufacturer's year. Ones that, as the business grows beyond small business accounting packages and manual processes, biopharma leaders often struggle to measure: Vendor Delivery PerformanceCustomer Delivery PerformanceManufacturing Schedule performanceQuality Management impactQuality Audit Performance Often, we see organizations fail to monitor these KPIs because they are growing fast, and their existing systems cannot keep up or they do not have the functionality needed to drive and sustain manufacturing excellence. Let’s explore how the right digital platform can be the difference between manufacturing excellence and missed opportunity. 1. Vendor Delivery Performance Managing the supply chain to...

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Merit Solutions helps life science companies create and manage documents with Microsoft Azure

New document management and control solution enables internal and external collaboration while meeting the most rigorous standards in a trusted Microsoft secure cloud environment We're pleased to share that Merit GxP Documents is now available. This monthly subscription-based Software as a Service (SaaS) document management and control solution helps life science organizations follow GxP guidelines, ISO standards, and maintain FDA compliance. It can be used stand-alone or as part of the broader Merit for Life Science and Microsoft Dynamics 365 ERP solution.  Merit GxP Docs offers biopharma and medical device companies a solution that is easily adopted by early-stage companies and scales to meet the needs of enterprises.Bill Burke, CEO of Merit Solutions “Working with an app that helps...

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Merit Solutions expands life science quality and inventory controls with latest release of Merit for Life Science

Cloud-first ERP advances Microsoft Dynamics 365 to digitally enable biotech, pharma and med device operations. “We’ve received incredible feedback about the value this release brings life science customers. Because Merit for Life Science is built to reside with Microsoft Dynamics 365, customers don’t have to hassle with managing multiple updates in a validated cloud environment – it all works together, seamlessly."Paul Challinor, VP of Product, Paul Challinor. WHEATON, IL — Merit Solutions today announced the general availability of Merit for Life Science spring release which includes enhancements to quality incidents, quality audits, and materials batch management for Microsoft Dynamics 365. This release helps customers manage quality processes, streamline FDA compliance, and expand...

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For Incident Management, Pick Your Course and Complete It

Distance runners know that the first objective of a race is to complete it, and the second is to respect the integrity of the course. Then they work backward from those two objectives to prepare for pace, considering variables such as weather, managing for resiliency in training and the race, and heeding other factors. If you think about an incident that you must manage in a life science company the same way, you’ll have a nice model for success with two exceptions. One, unlike the specific starting line for a race, the incident can start from a myriad of places inside or outside of your life science company. Two, the length of the race may be different depending on the nature and severity of the incident. The Unpredictable Incident Starting Line A patient may have a reaction to your...

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