Showing items tagged as Audit Management

  • 2021-bl-matt-lowe_132x132

    How to Not Fail an Inspection

    When I worked for medical device manufacturers, I experienced more than my fair share of audits and inspections. Even though we had good systems in place and strived for compliance, we still frequently weren’t prepared. If we had used connected digital systems, we could’ve saved ourselves a lot of worry and problems.

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  • 2021-bl-remote-audits_132x132

    Conducting Remote GxP Audits: Three Keys to Success

    The COVID-19 pandemic created unprecedented challenges for quality and compliance professionals in the pharmaceutical, biotech, and medical device industries. Staying on course toward product approval and audit schedules is dependent on maintaining a robust compliance roadmap, which includes sponsoring GxP audits.

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  • 2021-bl-shared-supplier-audit_132x132

    Medtech Suppliers Offering Shared Audits to Save Time and Reduce Exposure

    Last year brough a lot of changes to audits. In addition to remote audits, MedTech suppliers are learning the value of shared audit to be beneficial in working down the backlog of audit requests while reducing exposure in the plant.

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  • 2020-bl-remote-audits_132x132

    Conducting Audits at a Social Distance

    Regulated companies are settling into the reality of COVID-19. New operational paradigms present challenges to hosting audits. See how technology has made it more feasible to conduct various types of audits remotely.

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  • 2020-bl-conducting-supplier-audits_132x132

    5 Areas of Focus When Conducting a Supplier Audit

    For manufacturers, supplier auditing is essential to gaining visibility into whether a supplier’s products and processes are adhering to a defined quality standard. According to Terrance Holbrook, MasterControl’s director of product, there are five often-overlooked actions that manufacturers can take to improve how they conduct supplier audits.

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  • 2020-bl-bom_132x132

    3 Challenges that Bill of Materials Software Can Help Resolve

    A bill of materials (BOM) is crucial for ensuring a complete and accurate view of product parts and for protecting and analyzing the use of resources throughout the life cycle of a product. Any revision to a product’s design must be updated in the BOM, accurately identifying and listing what is required to produce the product. Because it extends to a variety of departments, BOM management often results in a number of common challenges for manufacturers.

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  • 2020-bl-tool-continuous-improvement_132x132

    Quality Audit—A Tool for Continuous Improvement and Compliance

    Audits are essential to regulated industries. The type of audit, who conducts it, and which regulations and standards are involved are all important. The process has its own challenges which have only been exacerbated in the current environment.

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  • 2020-bl-procurement-audits_132x132

    The Supplier Audit Learning Curve

    Supplier audits are the standardized testing of the manufacturing world. Suppliers and manufacturers are held to high quality standards and both must adhere to them to ensure final products are safe and effective. The key to this is a thorough supplier audit in which the supplier and manufacturer work together to improve quality throughout the supply chain.

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  • 2020-bl-thumb-remote-audits_312x132

    Remote Audits Reignite Regulated Companies and Supply Chains

    The COVID-19 pandemic disrupted many aspects of global societies, lifestyles and economies. Fortunately, technology has enabled the regulatory industry to continue functioning by conducting audits remotely. In this article, Derek Churchill, senior consultant at Quality Support Group (QSG), explains how remote audits work and how companies can prepare for this new type of audit.

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  • 2020-bl-thumb-how-to-increase-the-value-of-your-supplier-audits

    How to Increase the Value of Your Supplier Audits

    A manufacturer’s ability to maintain high-quality products and regulatory compliance depends largely on its suppliers’ own quality-related activities. Leveraged correctly, supplier audits can be an important tool that gives manufacturers greater visibility into these activities, according to Quality Support Group CEO Angelo Scangas.

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  • 2019-nl-bl-thumb-elf-on-shelf

    Santa’s Little Auditor

    It’s the time of year for parents to pull out the Elf on the Shelf and regale their children with stories of how their behavior gets reported back to Santa. Making sure those reports are accurate depends on whether the elf is using paper or digital solutions.

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  • 2019-bl-thumb-a-charlie-brown-audit-1

    It’s A Charlie Brown Audit

    Over the years, Charlie Brown and the Peanuts gang have regaled us with TV specials featuring their own brand of holiday celebrations. One show that never made it to the airwaves was the gang’s experience operating a medical device manufacturing plant that was having an audit. This article describes how that event played out.

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  • 2019-bl-thumb-process-validation-for-medical-devices

    Avoid FDA Audit Findings on Your Device by Performing Process Validation

    Medical device makers could save themselves time and heartache in reducing the number of regulatory findings when it comes to the FDA’s CFR Part 820 quality system regulations and ISO 13485. How? By understanding the benefits you get by fully implementing process validation to achieve higher levels of compliance.

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  • 2018-bl-thumb-guiding-medical-device-through-mdsap-audit-process

    MDSAP: Guiding Your Company Through the Audit Process

    Now that you understand what the Medical Device Single Audit Program (MDSAP) is and how it can benefit your medtech company, learn more about MDSAP’s audit process and how to successfully steer your company through the specifics of the journey. This is Part 2 of a three-part blog series about MDSAP.

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  • 2018-bl-thumb-fda-top-10-gmp-inspection-citations-2017-part2

    FDA Experts Give Top 10 FDA GMP Inspection Citations for FY 2017, Part 2

    Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The second part of a two-part series.

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  • 2018-bl-thumb-proving-effectiveness-mock-audits

    Proving the Effectiveness of Mock FDA Audits

    A mock U.S. Food and Drug Administration (FDA) audit can be conducted by an internal team of employees qualified by experience in regulatory compliance or by an external team with previous FDA work experience. Incorporating routine mock FDA audits can help your organization prepare for a FDA audit as well as reduce the number of audit observations and repeat observations received from regulatory authorities.

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  • 2017-bl-coping-with-scoping-page-image

    Coping with Scoping a CSV/Part 11 Audit

    You use computers on a daily basis, and you may even use the system that needs to be audited. But you don’t spend your day thinking about where all the system components are located, how services and software are combined, and what Part 11 requirements apply.

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  • Supplier Approval Challenges Under FSMA

    As a food safety and regulatory consultant, I work with diverse clients who face many different challenges with Food Safety Modernization Act (FSMA) implementation. The ones that are the hardest to address fall into the intersection between company policy and regulatory requirements. Supply-chain approval is a major challenge for many larger corporate clients, as well as smaller clients who must remain flexible to maintain profitability. The requirements of the Foreign Supplier Verification Prog

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  • What Does Risk-Based Monitoring Mean for QA Auditing?

    By now, we all know that risk-based monitoring (RBM) isn’t just about changing the role of the clinical research associate (CRA); it’s transforming the way clinical studies are managed. So what does that mean for quality assurance (QA) teams who audit these new processes? Polaris president Celine Clive led a roundtable discussion about RBM and its implications for auditing at November’s North Carolina Regulatory Affairs Forum (NCRAF) meeting.

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  • How to Address the Top 3 Supplier Management Issues

    Medical device manufacturers rely on suppliers for many things. Choosing the right vendors and managing them effectively can increase a manufacturer’s efficiency—in terms of time, cost, and quality. Unfortunately, suppliers can also sometimes put their clients in hot water when their quality standards are below par.

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