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GxP Lifeline
  • 2020-bl-501k-guidance_132x132

    FDA Details Post-COVID Transition Guidelines for EUA Devices

    In February 2020, the FDA granted emergency use authorization (EUA) to certain medical devices needed to address the challenges imposed by the COVID-19 virus. The agency recently drafted two new guidances to make preparations for med device companies to return to normal regulatory operations.

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  • The History of the FD&C Act and Consumer Protection

    Life Before Consumer Protection and the Food, Drug, and Cosmetic Act

    Starting as a small Bureau of Chemistry taking an interest in chemical preservatives, the FDA has grown into one of the largest agencies in the world and accounts for 20 cents of every consumer dollar spent. Although no one is keen on rules, as we look back on history it is clear why FDA regulations are crucial when it comes to consumer protection. Being able to keep up with their extensive list of standards is now only possible through digitization. Lucky for us, we are in an era of rapidly developing technology that will make it possible for manufacturers in all industries to gain quick FDA approval and be on market in record time.

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  • 3 Tips for Effective Risk Analysis in the Medical Device Industry featured by MasterControl

    3 Tips for an Effective Medical Device Risk Analysis

    Medical device manufacturers need to manage risk from the beginning of product design and continue throughout the full product lifecycle - anything less jeopardizes product quality. Connected risk analysis is essential because it gives you a holistic view of risks and their potential impact. Having this level of visibility requires a digital quality management system.

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  • 7 21 CFR Part 11 Med Device Manufacturers Compliance Requirements

    21 CFR Part 11 Compliance: 7 Must-Have System Features for Medical Device Manufacturers

    21 CFR Part 11, the regulation that defines the requirements for electronic records and signatures, can so overwhelm medical device manufacturers that many persist with their inefficient paper-based processes. But device firms that hesitate to digitize are falling behind. Learn seven core requirements electronic systems must address to remain compliant.

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  • How Northeast Scientific leverages MasterControl’s Medical Device Manufacturing execution software.

    Vision and Paperless Manufacturing Operations Make Northeast Scientific a Medical Device Industry Leader

    Many medical device manufacturing businesses are busily exploring ways to reduce the soaring costs of health care. Medical device remanufacturer Northeast Scientific is contributing to the effort by repurposing single-use devices (SUDs) to make them fit and safe to reuse.

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  • 3 Reasons to adopt a data-centric quality mindset for life sciences.

    3 Reasons You Should Adopt a Data-Centric Quality Mindset

    To improve quality, life sciences companies need to bring that data together, use automated analytics tools, and use artificial intelligence (AI) to improve performance. There are three main ways we’re preparing to help you do that.

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  • How to reduce human errors in the pharma industry with paperless manufacturing.

    Why Paperless Manufacturing Is Critical to the Pharmaceutical Industry

    In addition to focusing on more resilient supply chains, the pharma industry needs to prioritize ways to reduce human error in manufacturing. Human errors cost time and money, but they are often preventable.

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  • 7 key concepts to understand the FDA’s Quality System Approach for the Pharma Industry.

    7 Key Concepts in the FDA’s Quality System Guidance for Pharma

    These seven concepts are critical to understanding the U.S. Food and Drug Administration’s guidance “Quality Systems Approach to the Pharmaceutical Current Good Manufacturing Practice Regulations.”

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  • MasterControl’s Medical device QMS can help comply with medical device quality regulations.

    4 Ways to Prepare for UK Medical Device Regulations (MDRs)

    The United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) recently issued new guidance pertaining to regulated medical devices in the UK. Here’s how to prepare.

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  • 3 tips to choose a pharma contract manufacturing organization featured by MasterControl

    Three Tips for Pharma Picking a CMO

    Pharmaceutical companies need to partner with contract manufacturers capable of maintaining impeccable product quality. Follow these three tips to find a CMO in the pharma industry that can meet and exceed expectations.

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  • Supply chain best practices for the medical device industry

    Medical Device Supply Chain Backup

    It pays to have backup plans, and the supply chain is no different. Constantly fluctuating COVID-19 protocols and transportation issues continue to plague the medical device industry, but there are steps that can be taken to deal with these problems.

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  • MasterControl’s Digital Quality Management System for Pharma Companies to avoid compliance and regulatory mistakes.

    5 Pharma Compliance Mistakes to Avoid

    No pharma company wants to fail an inspection, and yet it’s common for these five mistakes to interfere with compliance efforts. Industry expert Nicole Cannon offers tips on how to avoid them along with insight into how digitization can be part of the solution. Follow her advice to get safe, effective products to market quickly.

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  • Medical Device Manufacturing Digitization Trends and Best Practices with MasterControl Manufacturing Software

    Medical Device Manufacturing Trends, Part 1: Resilient Supply Chains Require Modern Tools

    While visibility, agility, and responsiveness have been priorities in managing supply chains for decades, the disruption and volatility around the COVID-19 pandemic amplified their critical role. In doing so, it brought to light the need to digitize and integrate supply chain systems to ensure all relevant data and insights can be connected for optimal resiliency. To protect themselves in the face of supply chain volatility, medical device manufacturers should reassess their supply chain capabilities with an eye toward proactive, tech-enabled solutions.

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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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  • Medical Device Manufacturing Digital Solution

    "Attain the Manufacturing Trifecta: Decrease Expenses, Increase Efficiency, and Accelerate Product Release"

    A medical device manufacturer was working across two disparate systems. The result? Mistakes made their way into the manufacturing process, which resulted in lengthy review times, and delayed speed to market. The solution was digitization, and it immediately saved them $42,000 per year.

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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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  • GxP Lifeline, a blog by MasterControl: image of hands scrolling on a tablet with a city background

    Not-To-Be Missed Blog Posts From 2021

    Before 2021 is gone, catch up on our most informative blogs that will help you conquer the challenges you’ll face next year.

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  • 2021-bl-med-device-quality-trends_132x132

    Small Regulatory Steps for AI in SaMD

    Artificial intelligence (AI) in health care has enormous potential, but AI-enabled software as a medical device (SaMD) is charting new territory. Last year, regulators indicated some of their priorities for AI in SaMD and what regulations might look like in the future.

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  • 2021-bl-pharma-quality-trends_132x132

    3 Keys to Meeting Pharma Regulators’ Data Expectations

    FDA and other regulators are increasingly cracking down on pharma companies’ data integrity lapses. Learn the fundamentals of maximizing data usage that will help keep your quality and compliance activities aligned with regulatory expectations.

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  • 2021-bl-personalized-medicine-trends-2_132x132

    3 Ways to Rethink Regulatory Change in Personalized Medicine

    As the field of personalized medicine grows and evolves, and regulatory agencies such as the U.S. Food and Drug Administration (FDA) take steps to address regulatory oversight in the field, affected organizations should brace themselves for change and use it to their advantage. Here are three ways that companies in personalized medicine can approach regulatory obstacles as opportunities instead.

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