GxP Lifeline
  • 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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  • Digitization in manufacturing icon concept

    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_1200x628

    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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  • Medical device quality manager working online and learning about the FDA ISO 13485 harmonization.

    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    The U.S. Food and Drug Administration (FDA) recently released a draft guidance that would make it easier for medical device companies to comply with FDA regulations and the standard from the International Organization for Standardization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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  • 2022-bl-qx-risk-webinar_132x132

    Webinar: What You Need to Know About Quality Risk Management

    Past, present, or future, quality risk management is here to stay and continues to play an integral part of quality management systems (QMS). In the “Best Practices for Life Sciences Quality Leaders to Manage and Mitigate Risk” webinar, Peter Harris, MasterControl senior product manager, points to critical risk management failures and emergent solutions.

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  • 2022-bl-gxp-lifeline-industry-brief-promo_132x132

    Is Your QMS 21 CFR Part 11 Compliant? Ask These Questions to Find Out

    Moving away from paper and transitioning to a digital quality management system requires understanding FDA guidelines for electronic records and signatures – a key aspect of maintaining cGMP compliance. Ask these questions when considering a digital QMS solution.

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  • 2022-bl-gxp-lifeline-cw4a-1_132x132

    ERP is NOT a Substitute for a QMS

    An enterprise resource planning (ERP) system is a powerful tool, but it can’t take the place of a purpose-built quality management system (QMS). CloudWorks4All’s Ross Stoval explains why a dual ERP/QMS backbone is integral to success in life sciences industries.

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  • 2022-bl-mx-roi-calculator-promotion_132x132

    What Are the Measurable Benefits of Modern MES Software?

    While most manufacturers agree that digitization is essential to their success, most today can’t afford an expensive and time-consuming implementation of traditional manufacturing execution software with a slow return on investment. Implementation of a modern manufacturing execution system (MES) solution is fast and, once implemented, can deliver results quickly.

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  • 2022-bl-gxp-lifeline-eqms-implementation_132x132

    6 Solutions eQMS Software Provides Startups

    Most startups in the medical device industry understand that they could streamline operations with an electronic quality management system (eQMS), but just don’t know if the benefits are worth the cost. Cannon Quality Group highlights six solutions an eQMS provides for medtech startups.

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  • 2022-bl-compliance-audits-ib-promotion_132x132

    4 Essential Components of an Audit Management System

    Dealing with remote compliance audits and inspections presented unique challenges. The new hybrid approach does have benefits, but also maintains some of the challenges from in-person and remote audits.

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  • 2022-bl-continous-improvement_132x132

    Creating a Lean Culture of Continuous Improvement in Manufacturing

    Every manufacturer aims for continuous improvement, but one of the biggest obstacles to achieving it is getting everyone on board with new processes or solutions that will make it possible. Find out how applying a hierarchy of needs approach to a 6S program makes it makes it more likely that your teams will adopt new lean manufacturing processes or continuous improvement software.

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  • 2022-bl-22-summit-recap_132x132

    Masters Summit 2022 Recap: 3 Takeaways for Medical Device Manufacturers

    Masters Summit 2022 was a week of world-class education, insightful speakers, networking with industry peers, and fun. Find out which three themes repeatedly surfaced at this year’s event and what they mean for the future of medical device manufacturing.

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