Recalls can seem like the end of the world, but new FDA guidance seeks to change that. With a focus on training, record keeping and procedures, the recommendations are most effective with the help of automation and digitization.
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Beginnings are important because they often give a first impression. Today is a landmark day for MasterControl as we introduce not just our new look and feel, but also a renewed commitment to customers and an integrated platform of enterprise solutions. Today changes everything because #QualityChangesEverything.
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Quality and compliance are not what they were 25 years ago, 10 years ago, or even five years ago. And neither is MasterControl. Today, we launch the new MasterControl brand.
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The Identification of Medicinal Products (IDMP) is a set of ISO data standards that will help ensure that pharma organizations around the world speak the same language when it comes to product information and definitions. Find out how IDMP can also help improve your company’s internal quality processes.
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Pharmaceutical manufacturers depend on innovation and new technologies to find new cost-effective ways of speeding up the drug development process. 3D printing (3DP) allows greater flexibility during the discovery process through rapid prototyping formulations and the potential for on-demand production of clinical samples. Learn how 3DP may change the way pharma does business.
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Revolutions often take just the smallest act to become a widespread movement for change. J. Sterling Morton kicked off a worldwide forestation revolution in 1872, aka, Arbor Day. And digital transformation is currently revolutionizing the way life sciences and manufacturing companies do business. Declare “War on Paper” by joining the call to arms to go paperless.
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Human factors engineering (HFE), also called usability engineering, in an essential part of user experience design and a major component in ensuring that human well-being and system performance are optimized. Learn why device manufacturers can best benefit from HFE processes when they are integrated into the existing product development phase.
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Cannabis is in. It’s achieved a level of trendiness that few, if any, ingredients ever have. Nutraceutical companies are pushing the envelope when it comes to cannabis products, but there are a number of legal ramifications that need to be considered before jumping into this market.
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Life science and other companies doing business in FDA- and ISO-regulated environments understand how critical quality control and quality assurance are to successful quality management. “Quality control” and “quality assurance” are often used interchangeably when referring to activities conducted to ensure the quality of a product, service or process. Some quality control and quality assurance activities are interrelated, but the two are not necessarily interchangeable. Understanding the difference between the two quality processes is important, and a robust electronic quality management system (EQMS) will enable organizations to better manage both.
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A lot has changed since MasterControl’s beginning in 1993. As technology transforms the way we do business and quality becomes a true competitive advantage, MasterControl is evolving to better support the companies and industries we serve. We’re excited to announce that MasterControl will unveil a new look on May 1.
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A new phase of the Industrial Revolution is ushering in new technologies and modernized operational strategies that no life sciences industry executive can afford to ignore. Regulated companies are highly encouraged to plan for future relevance and success by modernizing key processes and operations.
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Don’t expect a breakthrough technology such as 3D printing or AI-driven medical devices this year. Instead, industry experts anticipate that existing innovative products will gather momentum — among them: devices for minimally invasive procedures, light-therapy-based devices, and human cells, tissues, and cellular and tissue products (HCT/P).
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Noticing an increase in violations of current good manufacturing practices (CGMP) regarding data integrity, the U.S. Food and Drug Administration (FDA) drafted a question-and-answer-based guidance to address some of the frequently asked questions and to clarify the role of data integrity in drug manufacturing.
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In order to maintain the highest standards, regulatory bodies are continually tweaking their drug registration requirements for highly controlled products. To keep up with these changes and avoid costly technical errors during the submissions process, pharma organizations are making sure they’re up to speed with regulators’ most up-to-date validation criteria.
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Part 2 of the “Thriving in a Digital Era” article series takes a deep dive into how companies are strategically mapping out their future by leveraging modernized technologies and moving their critical business functions to the cloud.
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Nothing can result in more frustrations for a medical device manufacturer than the complexities and headaches that occur during the product design approval process. But by developing a comprehensive bill of materials (BOM) strategy that boosts design control, your organization can avoid pitfalls and increase the turnaround time of deliverables.
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Another phase of the industrial revolution — dubbed Industry 4.0 — is underway and gaining momentum. While the previous phases of the industrial revolution have been about adopting new technologies, Industry 4.0 is about redefining the organizational culture.
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Although it’s a relatively new technology, blockchain has many promising use cases for manufacturers, and new applications of the technology are being introduced at an accelerated pace. Just as digital and cloud technology have caused a major disruption for paper-based enterprises, blockchain has emerged as the next-gen technology disruptor, meaning manufacturers must acknowledge and prepare for the transformation ahead.
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Cloud technology has reached a level of maturity where many regulated organizations are discovering that operating in the cloud is becoming essential, rather than an option. A new white paper discusses the benefits of moving to the cloud and how cloud service providers are making the migration process smoother and faster.
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Beer has long been a staple beverage in human society. Beyond its taste and nutritional characteristics, beer’s greatest virtue is its ability to create shared social experiences for people the world over. To quench their thirst for innovative flavors, local goods and the highest possible quality, today’s beer drinkers are turning to craft beer in droves.
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