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GxP Lifeline
  • 2020-bl-manufacturing-excellence-06_132x132

    GxP Training Redefined?

    To meet GxP training requirements, it’s important to understand the basics: what GxP means, how it relates to regulatory compliance, and how organizational change management can help you ensure your team receives adequate and consistent training.

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  • 2020-bl-connectivity-02_132x132

    A Q&A: the Trials and Triumphs of Validation

    Sequence Senior Consultant Peter McGrath weighs in on the struggles of traditional computer system validation (CSV), and how they can be solved with a risk-based approach. Months of time are spent on traditional CSV to the process, which produces piles of documentation. It doesn't have to be that way.

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  • 2021-bl-infrastructure-accessibility_132x132

    3 Practical Ways to Improve Infrastructure Agility in Pharma

    If nothing else, the COVID-19 pandemic proved to pharmaceutical companies that digitally integrated processes are the key to surviving a crisis. If your organization has difficulty connecting people, processes, and systems, there are three pragmatic measures you can take to bolster your existing infrastructure, help ensure secure connections, and enhance collaborative work.

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  • 2021-bl-personalized-medicine_132x132

    Harnessing Digital Transformation to Drive Innovation in Personalized Medicine

    In 2020, the COVID-19 pandemic brought to light the importance and acceleration of digitization. As precision medicine organizations continue reviewing and adjusting processes beyond the COVID-19 pandemic, there are some practical applications to consider in their efforts to embrace a modern approach to technology.

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  • 2021-bl-cmo-trend-brief_132x132

    CMOs and the Speed of Personalized Medicine

    In the growing field of personalized medicine, there are significant opportunities for contract manufacturers, and the challenge to keep up with demand can be met by adopting the right technology.

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  • 2021-bl-weaver-logo_132x132

    Weaver and Company: Digitization Streamlined Quality and Production

    Since its founding in 1978, medical device manufacturer Weaver and Company has grown, regulations relevant to its products have evolved, and paper-based processes posed greater risk. Recognizing that managing paper quality and production documents was no longer practical, the Colorado-based company has taken steps to modernize with MasterControl's digital quality management and manufacturing solutions.

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  • 2021-bl-what-possible-life-sciences_132x132

    AI Redefines What’s Possible in Life Sciences

    Artificial intelligence (AI) technology has become pivotal in mainstream health care. The influx of big tech firms collaborating with incumbent life sciences companies to develop AI-based medical devices indicates that this trend will continue at a rapid pace.

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  • 2021-bl-gcp-violations_132x132

    Good Clinical Practices and 5 Common GCP Violations in Clinical Studies

    Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions, including drugs, biologics, devices, and therapy protocols. These trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety. Good Clinical Practices (GCPs) provide a platform for the quality of the data and a unified standard for the conduct of clinical trials. Understand the most common issues cited in U.S. Food and Drug Administration (FDA) inspections of clinical trials, and know how to avoid them.

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  • 2021-bl-qarad_132x132

    Should Design and Life Cycle Management of an eIFU Solution Follow EN62304?

    Electronic distribution of instructions for use (eIFU) are becoming widely used among medical device manufacturers. Due to the increasing popularity, it is critical to understand eIFU within the context of regulations, particularly Europe’s new medical device regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

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  • jon-b-blog_01_358x160

    Rapid Acceleration in Technology for Life Sciences Quality and Manufacturing

    We have built technology for life sciences quality and manufacturing for more than 25 years and I have been involved in that effort for 19 years. It wasn’t until 2014 that we realized the why behind what we do and it wasn’t until 2020 that our mission became crystal clear to everyone on our teams.

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  • 2020-bl-2020-qa-vs-qc_132x132-main-thumb

    Get Quality Clarity: Your Guide to Understanding Quality’s Interactive Elements

    To actualize quality, you first must define the concept and clarify its objectives. Explore the relationships between the various functions that contribute to the overall quality management system (QMS) and learn about the critical role digital tools play in helping companies meet their quality goals.

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  • 2021-bl-lean-documents_132x132

    Principles of Lean Documentation

    Controlled documents tend to be weighed down with unnecessary information. When lean principles are applied to documentation practices, it becomes evident that most documents can be trimmed down to a comprehensive and useful level while maintaining compliance.

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  • 2021-bl-transitioning-ivdr_132x132

    Challenges with Transitioning to the EU In Vitro Diagnostic Devices Regulation

    The deadline for the European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) is about a year away, and if you haven’t started preparing, now is the time. Understand the challenges you might face during the process and what you can do to address them.

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  • 2021-bl-fda-eu-inspections_132x132

    FDA vs. EU Inspections: Similarities and Differences

    In 2009, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched an initiative to harmonize regulatory supervision of clinical trials. It streamlines collaboration and information sharing between the two regulatory bodies on good clinical practice (GCP) inspections. Quality and compliance expert Maria Dorat gives an update on the initiative and explains how harmonization is working during COVID-19.

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  • 2021-bl-qa-cupply-chain_132x132

    Supply Chains Q&A: What to Consider Before Making Changes

    If manufacturers want to move business away from China, or elsewhere, there are important considerations to take into account. Cynthia Kalina-Kaminsky, Ph.D. and owner and consultant for Process & Strategy Solutions, working with Quality Support Group, explains more in this Q&A.

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  • 2021-bl-supply-chain-adaptability_132x132

    The Botanical Supply Chain Problem of 2021

    The start of the new year was a sign of hope, more so than any other year in recent history. However, even as we wait for things to get better, nutraceutical companies are facing severe supply chain problems due to increases in demand and transportation problems brought on by the pandemic.

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  • 2020-bl-quality-excellence-02_132x132

    5 Critical Factors in the SMART CAPA Process

    Just as the name implies, corrective and preventive actions (CAPA) requires action. The key is knowing exactly what kind of action to take to solve the problem and prevent it from happening again.

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  • 2021-bl-5-compliance-mistakes_132x132

    5 Common Compliance Problems and How to Avoid Them

    Five of the most common compliance problems and how to avoid them including documentation issues, lack of quality oversight, neglecting to assess risks, not learning from mistakes, and failure to follow through on commitments.

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  • 2021-bl-qualitech_132x132

    Artificial Intelligence Pharmaceutical Insights

    AI is moving quickly, and before long, it will play an integral role in the pharmaceutical sector. The benefits of AI include improving efficiency, streamlining production, and shortening the length of time it takes to conduct quality reviews. The result is getting product to market faster.

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  • 2021-bl-sue-marchant-plenary_132x132

    2021: The Year for Insights Into Quality Data

    The new year might turn out to be just as unpredictable as the old. But, there’s one thing that we at MasterControl have full confidence in: Quality data will become more accessible and provide more insights than ever before.

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