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GxP Lifeline
  • Pharma manufacturing professional following CAPA best practice.

    5 CAPA Best Practices for Life Sciences Manufacturers

    Effective corrective action/preventive action (CAPA) management isn’t just a regulatory requirement – it has a direct and measurable impact on product quality. If you want to optimize and simplify CAPA, these best practices provide the perfect starting point.

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  • 2022-bl-software-validation_132x132

    6 Steps to Simplify Software Validation

    The FDA requires companies to validate software used in regulatory environments. But the processes involved in validation are usually a drain on your time and resources. By following six fundamental steps, you can adopt and validate software systems with greater ease.

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  • 2022-bl-gxp-lifeline-quality-by-design_132x132

    5 Key Elements of Quality by Design in Pharma

    End-of-line quality control comes too late in a competitive market. Regulators have long emphasized the systematic integration of quality within manufacturing processes to yield safer and more efficient pharmaceuticals. Get clarity on the role of Quality by Design (QbD) in modern pharma manufacturing and learn why a purpose-built quality management system is the most effective means of implementing it.

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  • MasterControl’s Ultimate Guide to Digitizing Pharma Manufacturing.

    Ultimate Guide Spotlights Pharma Manufacturing’s Transition to Digitization

    Numerous pharma companies are adopting digitization to ensure long-term relevance in the value chain. This post highlights MasterControl’s “The Ultimate Guide to Digitizing Pharma Manufacturing,” which takes an in-depth look at how the industry is transitioning to modernized operations.

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  • AVI systems enhances quality control in pharma manufacturing

    Automated Visual Inspection Delivers Transformational Improvements in Pharmaceutical Manufacturing

    Pharma manufacturers that adopt machine vision technologies are finding faster ways to detect and contain defects and avoid waste and rework. Learn why automated visual inspection (AVI) systems are the key to enhancing quality and productivity in evolving manufacturing environments.

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  • MasterControl’s Quality Management System: a solution for pharma’s data integrity issues

    Data Integrity in Pharma is Key to Compliance

    The FDA has signaled that data integrity is increasingly central to the drug approval process. Pharma organizations need to take the cue and adopt a quality management system that improves their ability to record and manage data, which will streamline their compliance efforts.

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  • Latest Pharmaceutical Manufacturing Trends

    Pharma Manufacturers Are Modernizing to Improve Quality and Safety

    Given the high numbers of pharmaceutical recalls and shortages, along with the current supply chain issues, product manufacturers are making modernization a higher priority. This post examines the new pharmaceutical manufacturing trends in modernization.

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  • 2021-bl-pharma-and-digitization_132x132

    Why is Pharma Resistant to Digitization?

    The pharmaceutical manufacturing industry resists digitization and continues to rely on paper as a single source of truth for record keeping. This outdated process is inefficient and can actually create more risk in the long run. Understand the primary causes of resistance to digitization and how to address those barriers.

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  • MasterControl Logo

    How to Avoid Pharma’s Top 5 FDA Form 483 Triggers

    Form 483 inspectional observation reports from the FDA result in painful and costly nightmares for pharmaceutical companies. Learn the top five reasons the agency issues Form 483s and find out best practices for steering clear of them.

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  • 2021-bl-drug-accountability-clinical-trials_132x132

    Ensuring Drug Accountability in Clinical Trials

    Drug accountability in clinical trials holds the organizations and people involved accountable for how they handle the drug being used. Accurate records are essential for compliant and reliable results.

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  • 2021-bl-cfr-part-11_132x132

    20 Years Later, 21 CFR Part 11 is More Relevant than Ever

    The U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11 guidance made electronic records and signatures as valid as paper records and handwritten signatures. The guidance changed the dynamic of data and records management by advocating modernized technology in the life sciences industry.

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  • 2021-bl-eu-qualified-person_132x132

    The European Qualified Person - What's It All About?

    According to good manufacturing practice (GMP) guidelines, companies in regulated environments must adhere to regulations that apply to the development of health care products. For medicinal product manufacturers in the European Union (EU), the person responsible for batch certification and the majority of quality processes is the Qualified Person (QP). This article details the duties and responsibilities of the QP and explains why it’s important for U.S.-based companies to understand the QP’s role.

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  • 2021-bl-explain-your-quality_132x132

    How to Explain Your Quality Job to Young Kids in 4 Steps

    When it was time to celebrate Career Day at my daughter’s school, she begged me to come talk to her first-grade class. I dreaded it. How do you explain to 6- and 7-year-olds what a quality manager does?

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  • 2021-bl-audit-checklists_132x132

    Understanding Auditor Checklists to Help Prepare for Audits and Inspections

    A checklist can be a simple yet powerful tool that you use to stay focused and complete essential tasks quickly and efficiently. As an auditor’s tool, a checklist can help ensure a well-planned, systematic, and consistent approach to audits. If the best way for an organization to survive an audit is to always be ready for one, you will be better prepared if you have an idea of what questions an auditor would ask.

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  • 2020-bl-manufacturing-excellence-03_132x132

    Maintaining Quality in the Fast-Paced Contract Manufacturing Industry

    All eyes are on contract manufacturers to help make COVID-19 vaccinations available throughout the globe. Increased scrutiny of the industry has brought an issue to the forefront: maintaining product quality while working at a rapid pace. With a modern manufacturing solution, it’s possible to prioritize both.

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  • 2020-bl-matt-brawner-qa_132x132

    Risk Management: A Primer for Lean Quality Assurance

    Be proactive about managing risk. If you aren’t, you will find yourself managing a crisis instead. Learn more about the benefits of risk management and how it’s done.

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  • 2021-bl-unlocking-your-data-potential_132x132

    3 Data Access Enhancements That Expedite Drug Development and Approvals

    Regulators began increasing focus on data accuracy long before the pandemic, but it’s a trend that’s only continuing to gain more momentum. Discover how data connectivity improvements are helping pharma companies align with regulatory dynamics and get drug products to market faster.

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  • 2021-bl-infrastructure-accessibility_132x132

    3 Practical Ways to Improve Infrastructure Agility in Pharma

    If nothing else, the COVID-19 pandemic proved to pharmaceutical companies that digitally integrated processes are the key to surviving a crisis. If your organization has difficulty connecting people, processes, and systems, there are three pragmatic measures you can take to bolster your existing infrastructure, help ensure secure connections, and enhance collaborative work.

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  • 2021-bl-effective-failure-investigation_132x132

    Is Your CAPA Process Providing Adequate Return on Investment? If Not, Why Not?

    The FDA has increased focus on the effectiveness of failure investigations during inspections in recent years. A review of 483 observations and warning letters clearly demonstrate the agency’s current concern about the adequacy of failure investigations to truly identify root cause.

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  • 2020-bl-six-steps-qualifying-suppliers_132x132

    Five Best Practices for Ensuring Supplier Quality

    Managing various suppliers is complicated. Lapses in process or product quality along the supply chain can have a negative impact on the end product. This article includes five best practices for establishing more effective oversight of suppliers throughout the supply chain.

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