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GxP Lifeline
  • 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

    How to Write 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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  • 2021-bl-six-corporate-oversights_132x132

    The Rise of Risk: How To Meet Pharma Regulators’ Expectations

    Regulators are intensifying focus on risk-based compliance approaches and pharma companies must adapt to the shift. Discover why process digitization provides the surest route to compliant risk management and learn how to prepare for the increasingly risk-based future of regulation.

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  • 2021-bl-fda-483-observation_132x132

    FDA Form 483 for Medical Devices: Top 5 Reasons to Receive a Warning

    Maintaining compliance in medical device manufacturing is colossal and complex. Any number of things can slip through the cracks and fall into the lap of a regulatory inspector. MasterControl’s industry brief “Most Common Reasons for FDA Form 483 Observations and Warning Letters in Medical Device Environments” helps companies identify and mitigate issues before they lead to extra work and costly delays.

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  • 2021-bl-disaster-recovery_132x132

    Disaster Recovery and Validation Fears Have a Remedy: The Cloud

    Natural and man-made disasters aren’t just terrifying – they can signal the death of your business if they lead to data loss, prolonged system outages, or downtime. Learn why cloud technologies take the panic out of disaster recovery and validation.

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  • 2021-bl-qarad-eifu_132x132

    What do Notified Bodies expect of your eIFU solution and its implementation?

    It is often crucial for safety that users have access to the correct instructions for use (IFU) when they need it. Therefore, it is logical that eIFU solutions are subject to strict requirements. Consequently, notified bodies (NB) will verify how a manufacturer has designed and implemented their eIFU solution in agreement with the requirements.

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  • 2021-bl-rajesh-talpade-_132x132

    The Future of Responsible AI in Life Sciences

    In life sciences, we are rapidly approaching a time when the use of artificial intelligence and machine learning (AI/ML) will be an industry norm.

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  • 2021-bl-enterey-paperless-to-digital_132x132

    Ask Aimy: The 4 Steps to Going Digital

    As companies learned during the pandemic, going digital is easier said than done. That’s why life sciences consulting firm Enterey uses a four-step process to help their clients transform their businesses. To walk us through it, we chatted with Manager Aimy Rehm about how to practically apply the steps and some potential scenarios companies may face.

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  • 2021-bl-personalized-medicine2_132x132

    Harnessing Data to Drive Improvements in Precision Medicine

    New technologies are enabling innovative advances in precision medicine. They are also generating vast amounts of data – across clinical studies, laboratories, patients, products, and more. As more enormous, disparate data sets are created, organizations need to be able to track, store, and analyze the information quickly and accurately. To fulfill the promise of precision medicine, organizations must harness all that data through greater connectivity and interoperability, increased visibility, and more data-driven insights.

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  • 2021-bl-implementing-a-qms_132x132

    QMS Implementation: 10 Key Steps for Implementing a Total Quality Management System

    Your company needs to an integrated, automated quality management system (QMS) to help you get your products to market faster and more efficiently. Where do you start? Consider these 10 steps to help you audit your current system and processes, get stakeholders onboard, and implement a QMS that will signifcantly improve your company's quality processes.

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  • 2021-bl-career-in-quality-management-pt-2_132x132

    Pursuing a Career in Quality Q&A — Part 2

    The quality management career has its ups and downs. We’ve already explored how to get into quality — now Quality Engineer Natalie Weber shares the good, the bad, and the hilarious parts of the job.

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  • 2021-bl-career-in-quality-management_132x132

    Pursuing a Career in Quality Q&A — Part 1

    The quality management career path isn’t as straightforward as getting a bachelor’s in quality management, which can be problematic if you’re considering a career in quality. That’s why we sat down with a quality expert to find out how to start a career in quality and what that looks like on a day-to-day basis.

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  • 2021-bl-coda-corp-quality-personnel_132x132

    Think Systems: Cause Quality

    With the right system, you can achieve and sustain a high level of quality. This includes having the ability to capture objective, up-to-date information so you can make data-driven decisions.

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  • 2020-bl-quality-excellence-03_132x132

    Solving Quality Issues and Problems: Go Beyond Root Cause to ‘Real’ Cause

    Extrapolating the root cause of a quality problem isn’t the same as determining the problem’s real cause. Learn how to discern real causes and avoid the cycle of recurring root cause investigations.

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  • 2020-bl-manufacturing-excellence-03_132x132

    Maintaining Quality in the Fast-Paced Contract Manufacturing Industry

    All eyes are on contract manufacturers to help make COVID-19 vaccinations available throughout the globe. Increased scrutiny of the industry has brought an issue to the forefront: maintaining product quality while working at a rapid pace. With a modern manufacturing solution, it’s possible to prioritize both.

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  • 2021-bl-compliance-checklist_132x132

    Q&A: A Risk-Based Approach to Compliant Audit Trails

    More regulated companies have transitioned to maintaining records and submitting information electronically. This involves tight data and records management and audit trails. In this article, Seyed Khorashahi, executive vice president of medical devices and CTO at Regulatory Compliance Associates (RCA) Inc., shares valuable insight on the anatomy of an audit trail and advises companies on how to comply with this critical component of 21 CFR Part 11.

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