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GxP Lifeline
  • Picture of two life science professionals standing using generative AI quality management software.

    How Generative AI Streamlines GxP Compliance in Life Sciences

    Generative AI is transforming the life sciences landscape and having a significant impact on GxP compliance efforts. In this blog post, Acumen Analytics CEO Kathleen Brunner examines the critical role AI is playing in redefining industry standards and changing the way companies approach compliance.

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  • Quality management professionals using a quality management software and pointing at a computer screen.

    Improving User Adoption With a Quality Management System

    Poor user adoption is often the biggest barrier companies face when implementing new software. If you’re implementing a new quality management system (QMS) solution, eQMS Consulting’s Melissa Leygan has five tips for encouraging user adoption.

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  • Statistics on using AI in quality management and manufacturing

    Top 5 Artificial Intelligence Tools for Quality and Manufacturing Professionals

    Artificial intelligence applications are taking the world by storm, but what are their practical applications in life sciences manufacturing? Read the results of MasterControl’s survey of more than 100 quality and manufacturing professionals who identified which AI tools would benefit them most.

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  • Life science professional using a modern eQMS software.

    Top 10 Traits to Look for in a Modern eQMS System

    A modern eQMS solution has become an indispensable asset in life sciences manufacturing. Total eQMS Management’s Jeff Sovis outlines 10 features you should look for if you’re looking to implement new quality and compliance management software.

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  • MasterControl’s case study featuring Navigate BioPharma and their success story in implementing MasterControl’s eQMS.

    Navigate BioPharma’s Digital Quality Management Success Story

    Want to make your quality processes more efficient? Discover how Navigate BioPharma has improved efficiency, simplified compliance, enhanced auditability, and boosted innovation by embracing digital quality management tools.

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  • Life science manufacturing professional working.

    CAPA Solutions for Manufacturing: How to Resolve Backlogged CAPAs in ISO 13485 Regulated Environments

    It’s not uncommon for medical device organizations to have bottlenecks with corrective actions/preventative actions (CAPAs). In this blog post, QA Connect CEO Leah Jones shares tips on streamlining CAPA management processes and improving root cause investigations.

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  • Medical device manufacturing professional holding a portable device and performing an internal audit.

    EU to U.S. Market, Part 2: Strategic Audits for Expansion Into U.S. Medical Device Market

    Part 2 in Cannon Quality Group’s blog series focuses on three ways manufacturers can leverage audits to streamline entry into the U.S. medical device market, avoid costly mistakes, and take advantage of this underused tool to ensure FDA compliance.

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  • MasterControl’s recent e-book on ISO and FDA compliance for medical device manufacturing

    A Blueprint for Navigating the Medical Device Regulatory Compliance Landscape

    The medical device industry serves a crucial role in improving patient lives, but navigating the complexities of regulatory compliance can be daunting. Discover resources that will give your quality and manufacturing teams the critical knowledge and practical strategies they need to tackle compliance challenges.

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  • Image of a life sciences professional using AI technology

    Harnessing DevOps for GxP Compliance: Streamlining Life Sciences Software Development

    GxP compliance in software development processes improves data safeguarding and promotes trust. In this post, SPK and Associates Vice President Michael Roberts examines how DevOps in life sciences manufacturing facilitates GxP compliance, innovation acceleration, and superior software quality.

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  • Life sciences manufacturing professional reviewing batch records with an EBR software.

    Accelerating Batch Record Reviews With Electronic Batch Records

    Electronic batch records (EBRs) can save you tons of time and eliminate frustration in reviews. Learn how you can reclaim time so you can focus on truly resolving quality issues instead of chasing paper.

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  • Life science professional using EBR system on portable device.

    Harnessing the Power of Electronic Batch Records: bioMérieux’s EBR Journey

    Paper batch records are a threat to data integrity and efficiency in life sciences manufacturing. If you're considering making the change to electronic batch records, bioMérieux's experience offers valuable insight into the selection process, implementation strategies, and the long-term benefits of modern EBR software.

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  • Life sciences manufacturing professionals working on correcting a nonconformance

    The Costly Impact of Nonconformance on Your Business

    Finding out the costs of nonconformance can help you improve, prevent future problems, and save money. In this blog post, Medpoint CEO Dr. David Orr examines different ways to measure nonconformance costs, including using nonconformance management software and having a good quality management system (QMS).

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  • MasterControl’s new e-book with best practices for FDA and ISO compliance in pharma manufacturing

    A Pharma Roadmap to Simplified FDA and ISO Compliance Management

    Are you overwhelmed by all the FDA and ISO regulatory requirements pharma companies must meet? If your organization faces the common types of FDA and ISO compliance management challenges covered in this blog, it’s time to implement a pharmaceutical compliance software solution that can help you overcome them.

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  • Life sciences manufacturing professional looking at EDMS on laptop.

    Mastering Document Control Chaos With Efficient Processes and Change Management Strategies

    As manufacturing operations evolve, there’s an increasing need for more efficient document management. Enterey’s Ryan Coughlin examines how life sciences manufacturers can turn document chaos into document control.

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  • MasterControl’s QMSR Q&A cover sheet

    What Medical Device Manufacturers Stand to Gain From Part 820/ISO 13485 Harmonization

    Now that the QMSR makes 21 CFR Part 820/ISO 13485 harmonization official, medical device manufacturers stand to benefit in a variety of ways. This blog post examines the significance of the harmonization to industry stakeholders.

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  • Digital map of the world to illustrate medical device compliance

    EU to U.S. Market: Understanding 3 Core Regulatory Contrasts

    Both the EU and U.S. markets are highly regulated, but there are important differences in medical device compliance that must be considered before taking the plunge. Cannon Quality Group examines three core regulatory contrasts that can make the difference in the success of your market entry.

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  • Cover image of MasterControl’s recent manufacturing logbook Q&A featuring Nutrawise

    Digital Logbooks: A Game-Changer for Nutrawise Health & Beauty

    As one of the largest manufacturers of collagen and turmeric in the U.S., Nutrawise Health & Beauty has dealt with numerous challenges involving paper logbooks. This post highlights the burdens the company has overcome by adopting logbook software.

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  • Life science professional working on 21 cfr part 11 compliance requirements.

    Checklist for Maintaining 21 CFR Part 11 Compliance

    Compliance with 21 CFR Part 11 is a big deal for life sciences companies. Failure to meet Part 11 requirements can result in serious consequences like product recalls and legal actions. Make sure all your regulatory bases are covered with this 21 CFR Part 11 compliance checklist.

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  • Top 10 Quality Event Management Goals for the New Year

    Reduce the number of quality events and errors with these top 10 goals for the New Year. Learn about advanced quality event management (QEM) solutions to help you achieve continuous improvement for years to come.

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  • Team of life science professionals review digital quality management articles on a portable device.

    Best of 2023: Last Year’s Most-Viewed Resources and Blog Posts

    Wondering which manufacturing and quality topics your colleagues, competitors, and industry peers are most interested in? Check out this list of the top blog posts, reports, guides, industry briefs, and webinars viewed last year.

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