background image for GxP Lifeline
GxP Lifeline
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • artificial-intelligence-132

    AI: Regulatory Framework for SaMD – Part Two

    The U.S. Food and Drug Administration (FDA) has proposed a regulatory framework around Artificial Intelligence/Machine Learning (AI/ML) for software as a medical device (SaMD). In the second part of a two-part series, past and current regulations are explored and explained.

    Full story
  • 2021-bl-mx-trend-brief_132x132

    4 Considerations for Manufacturers When Applying Digitization

    The movement toward digitization in manufacturing isn’t new, but the events of 2020 forced many organizations to adopt digital solutions quicker than previously planned. The digital changes that companies made over the past year are likely to remain after the crisis. As manufacturers look for ways to leverage technology to improve operations, they should consider at the following four ways to apply digitization.

    Full story
  • 2020-bl-matt-brawner-qa_132x132

    Risk Management: A Primer for Lean Quality Assurance

    Be proactive about managing risk. If you aren’t, you will find yourself managing a crisis instead. Learn more about the benefits of risk management and how it’s done.

    Full story
  • 2021-bl-cannon-qa-expenses_132x132

    Medtech Startups: Four Approaches to a QMS

    Early stage startups in the medical device/Medtech/in vitro diagnostic (IVD) world often struggle with when and how to implement a quality management system (QMS) into their operations.

    Full story
  • 2021-bl-mpr-ai-regulations_132x132

    AI: Regulatory Framework for SaMD – Part One

    As Artificial Intelligence/Machine Learning (AI/ML) gain momentum, particularly in software as medical device (SaMD), a regulatory framework is being put in place by the U.S. Food and Drug Administration (FDA). In the first part of a two-part series, the benefits of AI/ML are discussed along with the numerous considerations that need to be taken into account by regulatory bodies.

    Full story
  • 2021-bl-analytics-trends-brief_132x132

    May the Data Be With You

    Using the Force to make decisions in Star Wars works well. Tragically, since most of us don’t have that ability in the real world, we’d probably be better served if we listened to C-3PO more. While we’re short on protocol droids, we do have the tools to let you make decisions using advanced analytics and artificial intelligence (AI). And the odds of those paying off are considerably better than navigating an asteroid field.

    Full story
  • 2021-bl-ipm-compliance-crisis_132x132

    How to Avoid—but Prepare for—Compliance Crises

    If you prepare for and manage compliance crises with disciplined leadership and formal processes, you can minimize disruption and damage. In fact, your processes, communication, and adaptability can get stronger from the experience.

    Full story
  • 2021-bl-quality-inspiration_132x132

    Quality Inspiration: 5 Quality Quotes for Industry Professionals to Consider

    For professionals in the business of quality, inspiration can be found in all sorts of ways, from studying other industries to browsing the patent office or even taking a different route to work. A simple but often motivating approach is to look to words of wisdom from experts in their fields. Here are five insightful quotations, from a variety of fields, that carry quite a bit of truth for quality professionals.

    Full story
  • 2021-bl-medical-device-dhf_132x132

    Overview of the Medical Device Design History File, Technical File, and Design Dossier

    Medical device manufacturers must adhere to strict regulatory requirements, and the U.S. Food and Drug Administration’s 21 CFR Part 820 is a crucial set of regulatory guidelines meant to ensure the medical devices are high quality, safe, and effective. As part of these regulatory requirements, manufacturers must establish and maintain a medical device design history file (DHF) for each type of device. The following is an overview of the FDA’s design control and DHF expectations, as well as the role of the technical file/design dossier in European regulatory requirements.

    Full story
  • sara-bresee-thumb-gradient_132x132

    Insights Into APAC and Modern Manufacturing

    At MasterControl, we are broadening our gaze to the Asia-Pacific (APAC) region. Managing Director of APAC, Sara Bresee, weighs in on why modern manufacturing solutions are critical to APAC and around the globe. A digital system is what’s needed to be adaptable, meet regulatory requirements, and deliver the high level of quality your customers deserve.

    Full story
  • 2021-bl-embed-risk-based-thinking_132x132

    Embedding Risk-Based Thinking Into Quality Efforts with an Integrated Risk Management Software

    Many of the challenges inherent in developing regulated products fall into the realm of risk that manufacturers need to examine and mitigate prior to going to market. Risk management guidelines are spelled out in international regulations and standards, but true risk management goes deeper and is applied throughout the product’s life cycle.

    Full story
  • 2021-bl-brandwood_132x132

    Transition Plan: From Custom Device to Patient-matched

    As of the February 25, 2021, the December 2019 amendment of the Therapeutic Goods (Medical Devices) Regulations 2002 relating to the regulation of personalized medical devices was enacted. Understand the most notable changes.

    Full story
  • 2021-bl-unlocking-your-data-potential_132x132

    3 Data Access Enhancements That Expedite Drug Development and Approvals

    Regulators began increasing focus on data accuracy long before the pandemic, but it’s a trend that’s only continuing to gain more momentum. Discover how data connectivity improvements are helping pharma companies align with regulatory dynamics and get drug products to market faster.

    Full story
[ { "key": "fid#1", "value": ["GxP Lifeline Blog"] } ]