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GxP Lifeline
  • 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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    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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  • 2022-bl-medical-device-change-control_132x132

    Keys to Managing Change Control Effectively in Medical Device Manufacturing

    Change control is a critical capability for medical device manufacturers. But managing change effectively and efficiently is easier said than done. Read on to gain a deeper understanding of the core elements of change control, regulatory expectations for managing changes, and ways your organization can overcome common change-related challenges.

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  • 2022-bl-data-integrity-strategy_132x132

    How to Avoid Warning Letters for Data Integrity Nonconformances

    According to the U.S. Food and Drug Administration’s (FDA) guidance on data integrity, all data for regulated products must be complete, reliable, accurate, and consistent. Learn data management best practices to help ensure compliance with the stringent data integrity regulations.

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  • 2022-bl-logbooks_132x132

    Logbook Software: Another Triumph in Paperless Document Management

    Equipment management is an essential part of product manufacturing. Everything that happens with equipment must be logged, and all log entries must be complete, accurate, and legible. With paper-based logbooks, this process is cumbersome and time-consuming. See how digitized logbook software alleviates the headaches that come with logging equipment activities.

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  • 2022-bl-gxp-lifeline-validation-tips_132x132

    4 Key Takeaways From the FDA’s Software Validation Guidance

    After several years of delay, the U.S. Food and Drug Administration (FDA) issued its computer software assurance (CSA) guidance. Now that it’s out, here are some things from the guidance to keep in mind the next time a validation project comes up.

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  • 2022-bl-gxp-lifeline-mx-configurability_132x132

    Benefits of Configurability in Modern MES Solutions

    Rigid, hard-coded process configurations often make traditional manufacturing execution systems (MES) difficult to adapt and scale. The no-code configuration provided by modern MES solutions allows manufacturers to configure quickly and allows for the flexibility to adjust processes, material, and equipment changes for varying products.

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  • 2022-bl-quality-audit-tools_132x132

    5 Effective Quality Audit Tools and Tips

    Regularly auditing your quality management system is vital to maintain performance as well as compliance. Internal audits are an integral part of fulfilling global standard requirements, including those set forth by regulatory bodies like ISO, FDA, and ICH. Discover five tips that you can use for any type of audit you need to perform. Look here for the tools that can help you overcome the challenges of auditing and turn your findings into fixes.

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  • 2022-bl-capa-metrics_132x132

    3 Ways to Improve CAPA Metrics

    Quality events are inevitable, so it’s smart to use a CAPA management system. But, what constitutes a CAPA in the first place? Collecting nonconformance data with the right CAPA metrics can help you manage CAPAs more accurately and effectively — while avoiding future risk.

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    Why Pharma and Medtech Should Digitize Quality in a Down Market

    If you plan to delay technology investments to soften the recession’s blow, MasterControl CFO Michelle Tanner has news for you. Read on to get four recession survival tips and learn why those who don’t embrace advanced digital tools will lose ground in a down market.

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