At this point, COVID-19 has touched everyone’s life in some way. While we’re still struggling to keep up with the pandemic, many of our customers are undergoing initiatives to test and/or treat the virus.
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In a life sciences industry that highly values risk reduction, Good Automated Manufacturing Practices (GAMP) principles offer key insights on computer validation. GAMP 5 offers companies guidelines that can help ensure greater computer system compliance that reduces risk.
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In honor of Leonard Nimoy’s birthday, we’ve taken some of Spock’s words of wisdom and applied them to manufacturing. Because it’s only logical to get paper off the shop floor and fully digitize your processes.
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More and more life sciences companies are adopting asset-light models that heavily rely on a broad system of contract organizations. When supply chains expand, however, quality is often the first casualty. Learn the key questions to ask to ensure your system can enforce quality across the entire ecosystem.
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In the life sciences and other regulated industries, effective quality system management is essential. Companies can’t deliver a safety and effective product and comply with regulators without one. But it’s also crucial that companies take a risk-based approach to selecting and developing a quality system is well suited to their needs. Digital QMS solutions often offer unsurpassed benefits that a paper-based system can’t deliver.
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Coronavirus is the newest in a string of natural and man-made disasters and events disrupting the global supply chain. Governments and the private sector need to take a collaborative risk-management approach to planning measures to confront pandemics and other events that threaten the stability of global supply chains and our ability to meet ensuring demand.
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Advanced technology, market growth and regulatory disruption are creating an opportunity-rich but also demanding medical device space in 2020. An overview of some of the most impactful medtech trends of 2020 gives companies insights on how the industry is evolving and offers ways to flourish in a more data-driven ecosystem.
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Life sciences supply chains are unique. Pharmaceutical and medical device are even more so. Finding out industry standards and how your supply chain can improve are important questions that should be answered by the experts. Gartner recently produced “Supply Chain Benchmarking Data Reveals Differences Between Pharmaceutical and Medical Device Manufacturers” to provide those insights.
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Despite the investments that manufacturers have made in core digitization and automation, many producers stop short of digitizing their production records and other shop floor data collection efforts. The shop floor is a critical, but often overlooked, opportunity to make quality proactive rather than reactive. Every operator, step and output of the production process is a chance to establish quality and compliance – but only if operators have the tools to deliver quality at the source.
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More companies in all industries are migrating to a cloud environment to benefit from the advanced computing power, abundant data storage, and ability to perform complex functions. The cloud provides significant value; however, security has often been a source of concern. This article dispels the five most common myths about cloud security.
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Data has massive potential to revolutionize the life sciences for patients, regulators and for manufacturers. Yet at the same time, data integrity remains one of regulatory bodies’ biggest concerns. Learn what you can do to improve your company’s data integrity for regulatory inspections.
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The idea behind personalized medicine has always been the goal for health care professionals, but it’s becoming truly achievable with recent advances in technology. For pharmaceutical and medical device companies in the market, here are three trends to help you through 2020.
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The pharma industry has been gathering no moss going into 2020. New pharmaceutical manufacturing trends have been rapidly emerging, accompanied by regulatory initiatives to help mainstream the innovations. A new trend brief from MasterControl discusses how the new trends will impact the pharma industry.
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With all the new digital technologies impacting the life sciences, don’t forget about robotic process automation (RPA). The potential of RPA to automate repetitive, data-intensive processes can increase efficiencies and quality while freeing up your staff for more meaningful functions and assignments.
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It’s February, so stores are flooded with Valentine’s Day candy, flowers and greeting cards. None of these are for the quality-manufacturing relationship, but it still deserves some attention. If your quality and manufacturing departments have enough drama to give a rom-com a run for its money, it’s time to take the first step to bringing them together.
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In a new case study video, EpiBone, a Brooklyn-based regenerative medicine company developing living grafts for skeletal reconstruction, explains how it is leveraging MasterControl's QMS and manufacturing software to reduce errors and increase efficiency in the management of its quality processes and production records.
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Quality is an important part of doing business in regulatory environments. However, the differences between quality assurance and quality control can be hard to pin down. Learn how both play into quality management and how an enterprise quality management system simplifies them.
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As a new calendar year approaches, the technology at our disposal is exceeded only by the number of ways it can be applied to improve communication, understanding, planning and productivity. In fact, the last decade has seen such rapid advances in areas like connectivity, mobility, analytics, scalability and data that it has sparked a fourth industrial revolution, known as Industry 4.0. IT and operations teams are chomping at the bit to implement these new technologies to help them operate better, smarter and faster. But what does this mean for quality and the teams responsible for it?
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Companies whose quality management practices are document dependent are neglecting the insights trapped in their quality data. Learn about the promise and peril of unstructured data and how connectivity can unlock your quality function’s potential.
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Life sciences manufacturers’ reliance on outsourcing is on an upward trajectory. However, recent disruptions to how and why companies turn to contract manufacturing organizations (CMOs) and related contract services are changing the playing field. To maintain quality and control of products in this more dynamic outsourcing ecosystem, companies should seek greater collaboration.
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