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GxP Lifeline
  • 2023-bl-gxp-lifeline-batch-record-challenges_132x132

    Solve These 4 Common Manufacturing Production Records Challenges

    Life sciences manufacturers have a hard time keeping up with digital trends. Electronic batch records (EBR) can greatly simplify production, but getting them traditionally required investing in an expensive, rigid manufacturing execution system (MES). This is no longer the case as a modern MES can provide the same benefits at a lower cost with easier configuration.

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  • 2023-bl-gxp-lifeline-risk-based-audits_132x132

    Extending Quality Management Through Vendor Compliance Audits

    Functional relationships between manufacturers and their suppliers and vendors can lead to successful and long-lasting production operations. However, none of this can be taken on faith. Vendor compliance audits are key to maintaining both product and partnership viability that can operate well within compliance frameworks. Discover the key responsibilities, strategies, and tools necessary to extend your own quality management practices to your suppliers.

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  • 2023-bl-gxp-lifeline-namosol-csa-guidance_132x132

    Embracing and Implementing Computer Software Assurance Guidance

    Computer software assurance (CSA) is vital in manufacturing processes that rely on computers and automated processing systems. Namo Solutions’ Uday Veera explains why a risk-based framework provides the most effective CSA approach and offers tips to help manufacturers optimize their CSA efforts.

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  • 2023-bl-gxp-lifeline-dendreon-case-study_132x132

    Finding the Best Digital Solutions for Cell and Gene Therapy Manufacturing

    Cell and gene therapy manufacturers need modern digital solutions that can take paper out of the production process, connect their teams, and help them stay flexible. Learn how cell therapy pioneer Dendreon used MasterControl Manufacturing Excellence to do just that.

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  • Pharma Images_AdobeStock_571531832_132x132

    Assess Your Digital Manufacturing Maturity

    MasterControl recently conducted a study on the level of digitization deployed in pharma and medtech manufacturing. Find out how your company compares with your industry peers in terms of digital maturity and how to stay competitive in today’s market.

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  • 2023-bl-gxp-lifeline-med-device-continuous-improvement_132x132

    How Digital Transformation Is Impacting Medical Device Quality and Continuous Improvement

    With the advent of electronic quality management systems, AI, and other modern tools, medical device manufacturers are now able to optimize their operations to ensure that all products meet the highest standards. In this blog post, iDE8’s David Howarth explores the ways in which digital transformation is impacting medical device quality and continuous improvement.

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  • 2023-bl-gxp-lifeline-iso-9001-certification-audit_132x132

    5 Steps to Pass Your ISO 9001 Audit

    Audits are never a fun experience, but you can greatly reduce the stress if you prepare beforehand. Passing your ISO 9001 audit is completely doable by following these steps.

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    Transitioning to Validation 4.0: A Roadmap for the Journey

    With innovative technologies accelerating the speed with which computer systems can be validated, the decision to shift gears into Validation 4.0 sounds like a no-brainer. So why do so many life sciences companies struggle to find a starting point for implementation? Sware founder and CEO Bryan Ennis offers a proven roadmap for modern computer system validation success.

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  • 2023-bl-gxp-lifeline-medical-device-quality-trends-pt-4_132x132

    Medical Device Trends: Recall Readiness

    When it comes to recalls, medical devices don’t have the best track record and tend to outnumber those in other regulated industries. While it’s preferable to avoid recalls altogether, medical device companies need to have procedures in place just in case. Recommendations from the FDA help companies implement recalls faster and more accurately.

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  • 2023-bl-gxp-lifeline-patient-centricity_132x132

    Trends in Quality Management: 3 Paths to Patient Centricity in Pharma

    It can be difficult to articulate what patient centricity means for pharma, let alone the benefits. Read this post to gain a clearer understanding of this relatively new approach to quality management, where it originates from, and practical ways to align your quality management system (QMS) with patient-centric principles.

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  • 23Q2 GxP Lifeline Post Blog Images_132x132

    Why Electronic Manufacturing Logbooks Are Better Than Paper

    Paperless automation makes the mundane tasks of our daily lives easier. It can be even more powerful when used on the shop floor. Replacing paper logbooks with electronic logbook software can bring not only greater efficiency for manufacturers, but also bring them closer to complete digital maturity.

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    4 Digital Transformation Gaps in Pharma and Medtech Manufacturing

    At MasterControl, we wanted to determine the extent of digital maturity at life sciences companies in their manufacturing production management processes. We gained valuable insight from a survey of 152 life sciences companies worldwide in pharmaceutical, biotech, biologics, and medical device manufacturing. Find out how your organization can learn from the experience of others in overcoming production gaps.

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  • 2023-bl-gxp-lifeline-cqg-qms-for-startups_132x132

    4 Reasons Your Medical Device Startup is Ready for an eQMS

    Medtech startups face countless obstacles in their quest to achieve compliance and get products to market. While most recognize that modern technologies will enable them to reach their goals faster, it can be difficult to know when the time is right to invest in new solutions. Read on to learn four good reasons why a medical device startup should implement an electronic quality management system (eQMS) sooner rather than later.

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  • 2023-bl-gxp-lifeline-iso-13485_132x132

    How Regulatory Compliance Software Can Support the ISO 13485 Standard

    With the anticipated harmonization between the ISO 13485 standard and the U.S. Food and Drug Administration Quality System regulation (21 CFR Part 820) coming closer to fruition, it’s time for medical device designers and manufacturers to ask themselves a few questions, not the least of which being, “Am I ready?” and “What does it mean for me?” Another great one is this: “Is there a software solution that can make this easier?”

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  • 2023-bl-gxp-lifeline-supplier-quality-audits_132x132

    5 Steps to a Better Supplier Quality Audit

    Discover five often overlooked steps that can make your next supplier quality audit a more productive experience. Gain the major benefit of superior visibility into supplier performance and keep your supply chain moving.

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  • 2023-bl-gxp-lifeline-think-ocm_132x132

    Organizational Change Management Principles: Precede Action With Mindful Assessment

    Navigating and adapting to constant change requires more than a checklist mentality. Dr. Nancie Celini, president of Think OCM, explains why change management assessments must include mindful considerations and offers examples of the types of assessments that are ripe for a mindful approach.

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  • 2023-bl-gxp-lifeline-manufacturing-data-insights_132x132

    Unlocking the Power of Your Manufacturing Execution System

    To stay current with trends and gain a competitive edge in the life sciences market, manufacturing organizations collect a lot of data from various sources. For this level of data gathering, companies not only need more storage capacity, but they also need data storage technology that allows for rapid search and retrieval. Find out why industry leaders employ a data lake to store and manage large volumes of data.

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  • 2023-bl-gxp-lifeline-qrx-partners_132x132

    Risk-Based Supplier Management for Scaling Evaluation, Selection, and Control

    Regulators expect life sciences companies to take a risk-based approach to supplier management. But with so much supplier information to handle, how does an organization know which risks have been properly evaluated and controlled? QRx Partners’ Steve Gompertz examines the three critical phases of supplier management and explains how modern digital tools can streamline it.

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  • 2023-bl-gxp-lifeline-med-dev-quality-trends-cybersecurity_132x132

    Medical Device Trends: Medical Device Cybersecurity Guidance

    Connectivity offers many potential benefits to medical devices. Unfortunately, that connectivity also presents risks. That’s why regulators are coming out with cybersecurity guidance documents for medical device manufacturers.

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  • 2023-bl-gxp-lifeline-pharma-manufacturing-trends-3_132x132

    8 Ways EBR Software Boosts Efficiency in Pharma Manufacturing

    In modern pharma manufacturing, the traditional, paper-based approach to managing production records and other essential documentation is too time-consuming and prone to errors to be effective. Find out eight ways electronic batch record (EBR) software can supercharge your operational efficiency.

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