• engineer-showing-automation-system-132

    3 Key Elements to Data Security and Quality Control for Pharma Labs

    Data integrity in the drug industry is a vital element to ensure the safety, efficacy, and quality of drugs. Data integrity has remained an industry buzzword for many years, but the experience the industry has gained from shortened timelines of COVID-19 vaccine development and manufacturing has further strengthened its importance.

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  • 2021-bl-cfr-part-11_132x132

    20 Years Later, 21 CFR Part 11 is More Relevant than Ever

    The U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11 guidance made electronic records and signatures as valid as paper records and handwritten signatures. The guidance changed the dynamic of data and records management by advocating modernized technology in the life sciences industry.

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  • 2021-bl-matt-lowe_132x132

    How to Not Fail an Inspection

    When I worked for medical device manufacturers, I experienced more than my fair share of audits and inspections. Even though we had good systems in place and strived for compliance, we still frequently weren’t prepared. If we had used connected digital systems, we could’ve saved ourselves a lot of worry and problems.

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  • 2021-bl-regulatory-affairs_132x132

    Regulatory Affairs & Regulatory Operations: The Air Traffic Control Tower of Life Sciences

    The roles of regulatory operations professionals in the life sciences aren’t much different than those of air traffic controllers. They’re both focused on ensuring the safety of patients or passengers. Find out why regulatory operations experts are critical to companies’ speed of success and discover how advanced digital tools enable them to get products to more markets faster.

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  • 2021-bl-batch-record-challenges_132x132

    How to Solve 3 Common Batch Record Challenges

    Life sciences manufacturers' production processes should be assets, not liabilities. Yet too many manufacturing companies continue to allow their batch records to become liabilities by using manual, often paper-based systems that are error-prone, disconnected, and limited in the operational insights they provide. Here are three common batch record challenges manufacturers encounter and some practical ways an electronic batch record (EBR) solution can resolve them.

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  • 2021-bl-evolution-med-device_132x132

    The Evolution of Medical Device Clinical Trials: Adapting to Regulatory Changes

    Regulatory shifts and the ever-accelerating pace of innovation are necessitating a new approach to clinical investigations of medical devices. Learn about the unique regulatory pathways that devices traverse and why recent updates to compliance standards are calling for risk-based clinical strategies.

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    Test Method Validation, Measurement Systems, and Gauge R&R

    To compensate for the lack of agency guidance and still meet regulatory requirements, the medical device industry turned to Gauge Repeatability & Reproducibility (Gauge R&R) studies, but the FDA is making it clear these studies are not a suitable tool for validation.

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  • 2021-bl-eu-qualified-person_132x132

    The European Qualified Person - What's It All About?

    According to good manufacturing practice (GMP) guidelines, companies in regulated environments must adhere to regulations that apply to the development of health care products. For medicinal product manufacturers in the European Union (EU), the person responsible for batch certification and the majority of quality processes is the Qualified Person (QP). This article details the duties and responsibilities of the QP and explains why it’s important for U.S.-based companies to understand the QP’s role.

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  • 2021-bl-food-and-beverage_132x132

    Trends Redefining the Food and Beverage Industry

    The COVID-19 pandemic has been disruptive. At the same time, it has elevated consumers’ interest in pursuing healthier lifestyles, such as tracing food supply chains and consuming more immunity-boosting foods. This post examines new trends in the food and beverage industry and how manufacturers are adapting by implementing digitized technologies.

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  • 2021-bl-cannabis_132x132

    Cannabis Companies Can Build on 2020’s Success

    Last year was nerve-wracking for most industries to at least some degree. Cannabis was no different. When everything shut down cannabis retailers were left wondering how they’d stay in business. Fortunately for the industry, cannabis was largely declared an essential business, which let them increase sales by 47% over the previous year.

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  • 2020-bl-optimization-opportunities-data-ai_132x132

    Sneak Peek: How AI Will Change Your Job

    In our upcoming webinar, we’ll talk about what we can do with artificial intelligence (AI) now and how it’ll change the future of quality and manufacturing.

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  • 2021-bl-explain-your-quality_132x132

    How to Explain Your Quality Job to Young Kids in 4 Steps

    When it was time to celebrate Career Day at my daughter’s school, she begged me to come talk to her first-grade class. I dreaded it. How do you explain to 6- and 7-year-olds what a quality manager does?

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  • 2021-bl-10-questions-iso-13485_132x132

    Your Top 10 Questions About ISO 13485:2016—Answered!

    Five years ago, the International Organization for Standardization (ISO) published the ISO 13485:2016 standard. This post addresses the most common questions industry stakeholders have asked about the standard and its current status.

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  • 2021-bl-clinical-manufacturing_132x132

    The Secret to Clinical Manufacturing Success: Integrate Quality Early

    Quality takes on a new meaning in the clinical manufacturing sector, where flexibility is critical and production hinges on rapid yet exacting adjustments. Discover how integrating quality early in the manufacturing process gives companies an edge in the fast-paced and highly competitive field.

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  • 2021-bl-digitization-financial-success_132x132

    5 Ways Paper-Based Processes Hinder Financial Success

    If you haven't digitized yet, it's hurting the bottom line. As reported by Deloitte, digitally mature companies are, "about twice as likely as lower-maturity ones to report net profit margins an annual growth significantly above their industry average." Here's a look at five critical ways that paper-based processes are eating into revenue.

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  • 2021-bl-audit-checklists_132x132

    Understanding Auditor Checklists to Help Prepare for Audits and Inspections

    A checklist can be a simple yet powerful tool that you use to stay focused and complete essential tasks quickly and efficiently. As an auditor’s tool, a checklist can help ensure a well-planned, systematic, and consistent approach to audits. If the best way for an organization to survive an audit is to always be ready for one, you will be better prepared if you have an idea of what questions an auditor would ask.

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  • 2021-bl-cmo-and-digitization_132x132

    CMOs Gain Speed Through Digitization

    Between helping to deliver a vaccine to the world, and rising demands in personalized medicine, the contract manufacturing industry is traveling fast, but the market requires more. Digitization makes it possible to accelerate while delivering high-quality products to the market faster.

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  • 2021-bl-culture-of-quality_132x132

    6 Ways Quality Managers Can Build a Culture of Quality

    If you’re a quality manager, you have a demanding job. In a nutshell, you’re responsible for ensuring satisfactory and consistent quality throughout every successive step of the development of your products and services, a duty which requires you to wield a massive skill set and wear many different hats. Your daily existence revolves around quality; you dissect it and measure it and evaluate it and analyze it; you sleep, eat and breathe quality. And yet, how often do you really contemplate the concept of quality, and what it means to your company beyond the daily rigors of meeting customer requirements and upholding mandatory regulations and standards?

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  • 2021-bl-key-questions-quality-agreements_132x132

    5 Key Questions About Quality Agreements

    Quality agreements between organizations and contract manufacturing organizations (CMO), particularly in pharma, can be crucial to increasing ROI for a manufacturer. But there is a right way and a wrong way to approach quality agreements. Learn some best practices on how to produce more efficient and effective quality agreements.

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  • 2021-bl-clinical-monitoring-reports_132x132

    5 Guidelines for Writing a Useful Clinical Monitoring Report

    In clinical trials, site monitoring is required, but the report about the monitoring isn’t always given the attention it deserves. Prepare your next monitoring visit and the report by following these five tips to success.

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