An enterprise resource planning (ERP) system is a powerful tool, but it can’t take the place of a purpose-built quality management system (QMS). CloudWorks4All’s Ross Stoval explains why a dual ERP/QMS backbone is integral to success in life sciences industries.
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While most manufacturers agree that digitization is essential to their success, most today can’t afford an expensive and time-consuming implementation of traditional manufacturing execution software with a slow return on investment. Implementation of a modern manufacturing execution system (MES) solution is fast and, once implemented, can deliver results quickly.
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Most startups in the medical device industry understand that they could streamline operations with an electronic quality management system (eQMS), but just don’t know if the benefits are worth the cost. Cannon Quality Group highlights six solutions an eQMS provides for medtech startups.
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Dealing with remote compliance audits and inspections presented unique challenges. The new hybrid approach does have benefits, but also maintains some of the challenges from in-person and remote audits.
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Every manufacturer aims for continuous improvement, but one of the biggest obstacles to achieving it is getting everyone on board with new processes or solutions that will make it possible. Find out how applying a hierarchy of needs approach to a 6S program makes it makes it more likely that your teams will adopt new lean manufacturing processes or continuous improvement software.
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Masters Summit 2022 was a week of world-class education, insightful speakers, networking with industry peers, and fun. Find out which three themes repeatedly surfaced at this year’s event and what they mean for the future of medical device manufacturing.
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Change control is a critical capability for medical device manufacturers. But managing change effectively and efficiently is easier said than done. Read on to gain a deeper understanding of the core elements of change control, regulatory expectations for managing changes, and ways your organization can overcome common change-related challenges.
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According to the U.S. Food and Drug Administration’s (FDA) guidance on data integrity, all data for regulated products must be complete, reliable, accurate, and consistent. Learn data management best practices to help ensure compliance with the stringent data integrity regulations.
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Equipment management is an essential part of product manufacturing. Everything that happens with equipment must be logged, and all log entries must be complete, accurate, and legible. With paper-based logbooks, this process is cumbersome and time-consuming. See how digitized logbook software alleviates the headaches that come with logging equipment activities.
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After several years of delay, the U.S. Food and Drug Administration (FDA) issued its computer software assurance (CSA) guidance. Now that it’s out, here are some things from the guidance to keep in mind the next time a validation project comes up.
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If there’s one thing pharma contract manufacturers can count on, it’s the inevitability of supply chain disruptions. Yet even though a great deal of flexibility is required to be able to respond to destabilizing events appropriately, it can be difficult to foster. Learn about three initiatives pharma CMOs and CDMOs can undertake to elevate the flexibility of and visibility into their supply chains and streamline supplier management overall.
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Rigid, hard-coded process configurations often make traditional manufacturing execution systems (MES) difficult to adapt and scale. The no-code configuration provided by modern MES solutions allows manufacturers to configure quickly and allows for the flexibility to adjust processes, material, and equipment changes for varying products.
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Regularly auditing your quality management system is vital to maintain performance as well as compliance. Internal audits are an integral part of fulfilling global standard requirements, including those set forth by regulatory bodies like ISO, FDA, and ICH. Discover five tips that you can use for any type of audit you need to perform. Look here for the tools that can help you overcome the challenges of auditing and turn your findings into fixes.
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Quality events are inevitable, so it’s smart to use a CAPA management system. But, what constitutes a CAPA in the first place? Collecting nonconformance data with the right CAPA metrics can help you manage CAPAs more accurately and effectively — while avoiding future risk.
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If you plan to delay technology investments to soften the recession’s blow, MasterControl CFO Michelle Tanner has news for you. Read on to get four recession survival tips and learn why those who don’t embrace advanced digital tools will lose ground in a down market.
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The FDA requires companies to validate software used in regulatory environments. But the processes involved in validation are usually a drain on your time and resources. By following six fundamental steps, you can adopt and validate software systems with greater ease.
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To ensure you’re able to manufacture high-quality products and safeguard patient safety and data integrity, your organization must be able to effectively manage supplier quality. Find out how taking a risk-based approach and applying modern tools can improve your supplier management capabilities.
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Criminal opportunists are making a killing off counterfeit versions of life sciences manufacturers’ products. Learn why serialization is the key to getting fake products off the market and ensuring consumer safety.
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Streamlined production and quality processes are the keys to meeting the rising demand for cell and gene therapy manufacturing expertise and capacity. Find out how digitally bridging the gap between production and quality is helping companies thrive in the CGT space.
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In fully or partially paper-based manufacturing environments, the production line is an underappreciated opportunity to make quality proactive rather than reactive. Digital technology in manufacturing can ensure quality at every step of production.
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