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GxP Lifeline
  • 2023-bl-gxp-lifeline-fda-audit-process_132x132

    The FDA Just Called! Do You Have an FDA Audit Process in Place?

    If the U.S. Food and Drug Administration (FDA) called tomorrow to schedule a visit to your facility, would you panic or would you go on about your day, business as usual, knowing you have a robust FDA audit process in place?

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  • 2023-bl-gxp-lifeline-pharma-manufacturing-trends-2_132x132

    3 Steps to Achieving TQM in Pharma Manufacturing

    Total Quality Management (TQM) is based on the notion that an ounce of prevention is worth a pound of cure. But employees resist deviations from the status quo, which makes the implementation of TQM principles a challenge in most pharma manufacturing settings. Find out how three sensible steps that you can take today will create a foundation for TQM success tomorrow.

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  • 2022-bl-ultimate-guide-promotion_132x132

    How to Solve the Big Challenges of Cell and Gene Therapy Manufacturing

    Cell and gene therapy (CGT) manufacturing offers unique challenges regarding good manufacturing practices (GMP). Are paper batch records efficient enough to remain compliant? Learn how digital manufacturing solutions can solve some of CGTs biggest production issues.

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  • 2023-bl-gxp-lifeline-cant-miss-conferences_132x132

    5 Manufacturing and Quality Management Conferences You Shouldn’t Miss in 2023

    Professionals in the life sciences have an endless list of conferences and trade shows they can attend – but which events will give you the best reasons to attend? Find out which quality management and manufacturing conferences are the “can’t miss” events of 2023.

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  • 2023-bl-gxp-lifeline-pharma-quality-trends_132x132

    Pharma Quality Management Trends: 3 Ways an eQMS Enables Resource Resiliency

    Some of the most prominent pharmaceutical trends relate to the supply chain disruptions and the labor market shortages that coincided with peak COVID-19 lockdown periods. As a result, individuals, businesses, and entire industries are willfully redefining themselves and the ways that they connect to one another – staying connected despite critical disruptions. Find out how an eQMS solution can help you keep pace with these trends.

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  • 2023-bl-gxp-lifeline-med-dev-quality-trends_132x132

    FDA Remote Inspections - The Trend Continues

    We’ve been talking about remote audits and inspections since the COVID-19 pandemic first hit - and this trend isn’t going anywhere. What started as a necessity due to remote work quickly morphed into a process that regulatory authorities intend to continue well after the pandemic is over.

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  • 2021-bl-enterey-change-management_132x132

    Simplifying Complexity Through Process Improvement and Digitization

    Improving your business processes starts with an enhanced understanding of fundamentals. Read Enterey’s Ryan Coughlin examination of proven steps that enable companies to simplify change and quality management processes and the ways digital tools facilitate improvements.

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  • 2023-bl-gxp-lifeline-manufacturing-quality-metrics_132x132

    3 Reasons to Invest in Truly Paperless Manufacturing

    Implementing truly paperless manufacturing offers quality control and production record benefits. Read about three measurable areas that are improved by switching to a connected digital manufacturing solution.

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  • 2023-bl-gxp-lifeline-eu-mdr-idvr_132x132

    Does the EU MDR/IVDR Extension Allow Delay?

    With the EU MDR and IVDR regulations in effect, medical device manufacturers have legitimate concerns about meeting deadlines and transitioning to new rules. Learn everything you need to know about evolving EU regulations and steps you can take to align with key requirements.

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  • 2023-bl-gxp-lifeline-e2e-digitization_132x132

    How Medtech Manufacturers Can Achieve End-to-End Digitization in Manufacturing

    As medtech manufacturers take steps to modernize their operations through digitization in manufacturing, there are a few practical ways to put into practice the unprecedented digitization of every aspect of manufacturing.

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  • 2023-bl-gxp-lifeline-change-control-manufacturing_132x132

    The 7 C’s of a Compliant Manufacturing Change Control System

    Pharmaceutical and medical device manufacturers are increasingly looking for digital solutions to manage change control. Change control processes can be challenging to coordinate – especially in high-stakes environments. Read more to learn about change control requirements and seven characteristics of an efficient and compliant manufacturing change control system.

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  • 2023-bl-gxp-lifeline-med-device-quality-trends_132x132

    4 Things To Know About the 21 CFR Part 820/ISO 13485 Harmonization

    The U.S. Food and Drug Administration (FDA) recently released a draft guidance that would make it easier for medical device companies to comply with FDA regulations and the standard from the International Organization for Standardization (ISO).

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  • 2023-bl-gxp-lifeline-pharma-manufacturing-trends_132x132

    3 Steps to Developing Adaptability in Pharma Supply Management

    Pharma supply chains are more fragile and prone to disruption than we’d like to admit. But mitigating supply disruptions and minimizing their harmful effects requires greater flexibility and faster decision-making. Learn three steps pharma manufacturers can take to manage their supply chains more effectively.

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  • 2022-bl-gxp-lifeline-quality-maturity_132x132

    3 Ways to Adopt a Quality Management Maturity Model

    One prominent pharmaceutical trend shows how quality is leaning into quality management maturity (QMM) and finding ways to withstand lingering disruptions and expand its reach. Find out how digital transformation is key to their success.

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  • 2022-bl-gxp-lifeline-ide8-process-improvement_132x132

    Continuous Improvement in a Challenging Economic Climate

    Continuous improvement is a cost-effective way for medical device companies to ensure their quality processes remain consistent while also reducing costs and improving efficiency. Find out why continuous improvement efforts are critical to maintaining product quality in a challenging economic climate.

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  • 2022-bl-gxp-lifeline-top-posts_132x132

    Top 5 Quality Management and Digital Manufacturing Articles of 2022

    Wondering which topics spark the most interest among your peers in life sciences manufacturing and quality? Check out this list of the top five GxP Lifeline articles our readers perused last year.

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  • 2022-bl-elemental-machines-webinar_132x132

    How MES Integrations Give Pharma Manufacturers a Competitive Edge

    Pharma manufacturers are implementing an array of production-streamlining technologies to stay competitive. But even the most advanced tools won’t help you get ahead of competitors if they’re disconnected and your production operations rely on paper-based processes. Find out how system integrations are helping manufacturers accelerate production and make their operations more efficient.

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  • 2022-bl-gxp-lifeline-quality-4.0-oqsie_132x132

    Enabling Quality Leaders to Spearhead Quality 4.0

    Despite the momentum that Quality 4.0 transformation initiatives have gained in the life sciences, many such programs are at risk of failure. OQSIE’s Jaime Velez explains how document review enhancements and other quality process improvements can help quality leaders keep transformation initiatives on track.

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  • 2022-bl-gxp-lifeline-gmp-audit-findings_132x132

    5 Frequent GMP Audit Findings and How To Avoid Them

    There are several things to look at to help you achieve a compliant quality management system (QMS) and consequently pass inspections. Examples include your past history with compliance, internal GMP audits, as well as the most frequent citations that show up in the U.S. Food and Drug Association’s (FDA) audit findings lists. Find out what they are and how to prepare your system for a successful audit.

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  • 2022-bl-intuizi-regulatory-compliance_132x132

    How the Life Sciences Industry Can Benefit From Geospatial Location Data

    Life sciences companies are growing more reliant on location data as the key source of data for consumer engagement. Find out how advanced technologies that focus on location data help facilitate compliance, give companies gain insights into strategic business intelligence and consumer behaviors, and give them an edge in marketing planning so they can more effectively reach consumers.

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