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    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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    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 Documents

    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 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-shared-supplier-audit_132x132

    Medtech Suppliers Offering Shared Audits to Save Time and Reduce Exposure

    Last year brough a lot of changes to audits. In addition to remote audits, MedTech suppliers are learning the value of shared audit to be beneficial in working down the backlog of audit requests while reducing exposure in the plant.

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    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-coda-corp-change-management_132x132

    Change Management and Change Leadership: A Critical Relationship

    Change Management is a term we have all heard and regularly use. Unfortunately, we seem to use it generically, lacking the level of precision which would clearly differentiate between Managing Change and Leading Change.

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    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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  • 2021-bl-effective-failure-investigation_132x132

    Is Your CAPA Process Providing Adequate Return on Investment? If Not, Why Not?

    The FDA has increased focus on the effectiveness of failure investigations during inspections in recent years. A review of 483 observations and warning letters clearly demonstrate the agency’s current concern about the adequacy of failure investigations to truly identify root cause.

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  • 2021-bl-measuring-risk-management_132x132

    Measuring Risk Management Outcomes

    The task of measuring the benefits risk management brings to an organization is a challenging one. To overcome this challenge, the measurement of risk management performance needs to consider a wide range of factors.

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  • 2021-bl-wellington-foods_132x132

    Quality Is the Key Ingredient to Successful Manufacturing

    The president of Wellington Foods, a leading contract manufacturer of nutraceuticals, explains why quality should be an organization’s top priority. This approach helps manufacturers achieve better process control and plan for significant growth without worrying about highly complex manufacturing processes.

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  • 2021-bl-ai-emerging-tech_132x132

    3 Practical Ways to Prepare for Pharma’s AI-Driven Future

    Think only big pharma companies with deep pockets can benefit from artificial intelligence and other advanced technologies? Think again. AI is the future of pharma, and nowadays companies of all sizes are starting leverage it to streamline quality processes. Learn the pragmatic steps you can take today to position your company to get good returns on AI investments.

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  • 2021-bl-investigational-device_132x132

    FDA’s IDE: Data-Centric Approach to Med Device Innovation

    An Investigational Device Exemption (IDE) is a regulatory option that allows an investigational medical device to be used in a clinical study in order to collect safety and effectiveness data. This article explains why medical device manufacturers would seek an IDE and how they apply for the designation.

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  • 2021-bl-data-driven-quality-model_132x132

    Adopting a Data-Driven Quality Model: Essential for Quality and Compliance

    Life sciences companies have long generated vast amounts of data as a byproduct of their processes for developing and manufacturing products. Quality is one area of the business that is particularly dependent on data. This article explains how companies are emerging as leaders in their industries by implementing a data-driven approach to quality management.

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  • 2021-bl-understanding-acronyms_132x132

    Making Sense of LIMS, QMS, GMP and Other ERP Acronyms for Life Sciences

    Acronyms can look more like alphabet soup, but here is your cheat sheet to understand some of the most common ones used in life sciences manufacturing: LIMS, QMS, GMP and ERP.

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