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Quality Agreements With Contract Manufacturing Organisations (CMOs)
July 23, 2024
By James Jardine, Staff Writer, MasterControl
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Contract manufacturers in the pharma industry can count on one thing: the inevitability of supply chain disruptions. But reacting appropriately to destabilising events requires a great deal of flexibility – a trait that’s difficult for most companies to develop. Learn three steps pharma CMOs and CDMOs can take to optimise supplier management by enhancing the flexibility of and visibility into their supply chains.
Full storyContract manufacturers serve a vital role in the pharmaceutical industry, but it’s hard to select one that best fit your needs. Here are three tips for selecting pharma contract manufacturing partners that will help you achieve your business goals.
Full storyArtificial intelligence applications are taking the world by storm, but what are their practical applications in life sciences manufacturing? Read the results of MasterControl’s survey of more than 100 quality and manufacturing professionals who identified which AI tools would benefit them most.
Full storyThis blog post contributed by Cannon Quality Group focuses on three ways manufacturers can leverage audits to streamline entry into the U.S. medical device market, avoid costly mistakes, and take advantage of this underused tool to ensure FDA compliance.
Full storyPaper batch records are a threat to data integrity and efficiency in life sciences manufacturing. If you're considering making the change to electronic batch records, bioMérieux's experience offers valuable insight into the selection process, implementation strategies, and the long-term benefits of modern EBR software.
Full storyBoth the EU and U.S. markets are highly regulated, but there are important differences in medical device compliance that must be considered before taking the plunge. Cannon Quality Group examines three core regulatory contrasts that can make the difference in the success of your market entry.
Full storyEffective corrective action/preventive action (CAPA) management isn’t just a regulatory requirement – it has a direct and measurable impact on product quality. If you want to optimise and simplify CAPA, these best practices will help you get started.
Full storyQuality professionals are all too familiar with having to fit their organisations’ processes to match the rigid functionality of their software systems. But those days are coming to an end. Find out how a revolutionary new tool is going to give quality leaders unprecedented control and forever change the way they manage quality events.
Full storyDigital manufacturing solutions, such as modern electronic batch records (EBRs), are key to optimising your entire manufacturing operation and production staff. This post addresses key aspects of a good digital manufacturing solution and offers tips on choosing the right system.
Full storyLearn why it’s imperative for professionals in modern manufacturing environments to understand the value of digital work instructions, the increasingly important role of manufacturing work instruction software, and how these modern solutions fit into the broader manufacturing execution system (MES).
Full storySupplier performance greatly affects the cost, quality, delivery, and responsiveness of a manufacturer’s business. For any life sciences manufacturer whose product quality relies in part on a supplier’s own product or service, the organisation must be able to ensure or improve high supplier performance. Discover why supplier scorecards are a logical place to start.
Full storyAt MasterControl, we wanted to determine the extent of digital maturity at life sciences companies in their manufacturing production management processes. We gained valuable insight from a survey of 152 life sciences companies worldwide in pharmaceutical, biotech, biologics, and medical device manufacturing. Find out how your organisation can learn from the experience of others in overcoming production gaps.
Full storyDigitising is a difficult process that involves every department in an organisation. At MasterControl, we conducted original research on where the life sciences industry stands in its QMS digitisation efforts and how we can help you make progress on your journey and overcome these difficulties.
Full storyIt’s no secret that relationships can be complicated — even downright unhealthy. Figuring out where you stand and constantly having to decide your next course of action is exhausting. If you’re in life sciences manufacturing, you’re likely in an unhealthy relationship with paper batch records. Where is your relationship with paper headed? Take this quiz to find out.
Full storyProblematic quality processes can cause a rift between you and your auditor. If these issues aren’t addressed, you might find yourself dealing with the silent treatment. This quiz can tell you how things are going with your auditor.
Full storyAt MasterControl, we are broadening our gaze to the Asia-Pacific (APAC) region. Managing Director of APAC, Sara Bresee, weighs in on why modern manufacturing solutions are critical to APAC and around the globe. A digital system is what’s needed to be adaptable, meet regulatory requirements, and deliver the high level of quality your customers deserve.
Full storyDigital transformation initiatives were already underway among life sciences manufacturers before COVID-19 struck, but the volatility around the global pandemic brought to light the importance of digital technologies in the supply chain. Research indicates that companies digitised many activities 20-25 times faster as a result of COVID-19. Integrating digital technologies in the supply chain has enormous implications for life science organisations.
Full storyTo support advanced data technologies and to compete in a modern market, manufacturers must close the digital gap on the shop floor, where critical production processes remain paper-based and disconnected. Digitizing the paper-based production record process can close this gap by creating productive connections between people, processes, and systems throughout the manufacturing process and across the entire enterprise for a holistic view of production data.
Full storyIf you haven't digitized yet, it's hurting the bottom line. As reported by Deloitte, digitally mature companies are, "about twice as likely as lower-maturity ones to report net profit margins an annual growth significantly above their industry average." Here's a look at five critical ways that paper-based processes are eating into revenue.
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