• 2020-bl-managing-compliance-costs_132x132

    CLIA Certification: 3 Things You Need to Know

    Testing accuracy and reliability are the top priorities of any laboratory that conducts tests on humans. To demonstrate their commitment to testing integrity, facilities in the U.S. must adhere to Clinical Laboratory Improvement Amendments (CLIA) quality regulations. The path to CLIA certification begins by addressing three fundamental questions.

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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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  • Aviator Proves the Sky Is Not the Limit for Life-Changing Innovation

    Read how BraveHeart Wireless Inc. earned 510(k) approval for its Life Sensor Cardiac Monitor within one year.

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  • 2020-bl-reducing-human-error_132x132

    A Look at Reducing Human Error on the Manufacturing Floor

    CAPA’s will be effective when we can eliminate conditions (causes) that make people deviate from the expected outcome. Therefore, CAPA effectiveness should be measured by root cause recurrence and event recurrence.

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  • 2020-bl-5-w-of-quality-agreements_132x132

    Quality Agreements With Contract Manufacturing Organizations (CMOs)

    Life sciences companies are growing increasingly reliant on contract manufacturing partners as they strive to compete in a fast-paced and continually evolving industry. From the FDA’s perspective, those partnerships mean that both product owners and their contract facilities are responsible for CGMP compliance. Learn how quality agreements help both parties cover all their compliance bases.

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  • 2020-bl-using-connected-quality_132x132

    Using Connected Quality to Track Down Problems

    Mistakes are inevitable in any process. The problem is making sure those mistakes aren’t repeated and that any underlying issues are resolved. To do this, you need good systems in place for detecting problems, the severity of problems, determining a solution, and implementing that solution.

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  • 2020-bl-501k-guidance_132x132

    FDA’s New 510(k) Pathway Highlights Safety and Performance Data

    The U.S. Food and Drug Administration (FDA) continues to create avenues for life sciences companies to get products approved and on the market at a faster pace. The agency set up a new 510(k) pathway for achieving market approval, which is device-specific and based on safety and performance data. In pursuing this pathway, the agency emphasizes the importance of continuous improvement and effective data management.

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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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  • Happy Manufacturing Day!

    To celebrate Manufacturing Day, we’re encouraging future manufacturers to look at some of the exciting trends happening in the industry. This includes organizations coming together to address COVID-19 and stepping into the world of artificial intelligence.

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  • 2020-bl-matt-brawner-qa-part2_132x132

    An Expert Explains Data Integrity and Organizational Excellence – Part Two

    Data integrity is an integral part of organizational excellence. An expert explains why companies need to align their efforts with customer needs, one of which is adhering to all applicable regulations. Common mistakes around 21 CFR Part 11 are explored along with ways to avoid them.

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  • 2020-bl-gcp-compliance-hack_132x132

    GCP Compliance Hack: How to Avoid the Most Common Warning Letter Trigger

    The most frequently cited good clinical practice (GCP) violation is a failure to adhere to a study’s investigational plan. But there’s a straightforward solution to your protocol compliance woes. Hint: it doesn’t involve the disconnected, mostly paper-based systems currently used to manage clinical trials.

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  • 2020-bl-process-verification_132x132

    Process Verification vs. Process Validation: What You Need to Know

    Knowing if a manufacturing process needs to be verified or if it needs to be validated is often a conundrum for medical device makers. Learn the difference between the two compliance-critical activities and circumstances when each is required.

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  • 2020-bl-prepare-dhf-fda_132x132

    Is Your Design History File Prepared for an FDA Inspection?

    The prospect of an inspection by the U.S. Food and Drug Administration (FDA) causes dread for many manufacturers. If gone poorly, an FDA audit can have serious consequences. For medical device companies, noncompliance often falls under design control and document management, two critical areas that intersect with the design history file (DHF). The best way to get through an FDA inspection is to always be prepared for one.

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  • 2020-bl-matt-brawner-qa_132x132

    An Expert Explains Data Integrity and Organizational Excellence – Part One

    Data integrity is closely related to organizational excellence. An expert explains best practices and mistakes to avoid.

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  • 2020-bl-things-go-sideways_132x132

    What to do When Things Go Sideways (And How to Recover)

    When you experience an event such as a product recall or low production rates, resolving these issues can be challenging. Your best bet is to have a road map that helps you get to the root of the problem and recover quickly.

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  • 2020-bl-medtech-webinar-series-overview_132x132

    Navigating Life Sciences Manufacturing During a Pandemic

    Life sciences manufacturing during COVID-19 has changed dramatically. That’s why we’ve worked with MedTech Association and MASSMedic to bring you a 10-part webinar series about how to scale and pivot during the pandemic.

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  • 2020-bl-cannabis-supply-chain_132x132

    Compliance Data: A New Solution for Maintaining Cannabis Supply Continuity

    Cannabis supply chains need to deliver high-quality products with consistency and foresight. Using state compliance data, it’s possible to ensure supply networks and regulators have all the necessary information they need for greater visibility and collaboration.

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  • 2020-bl-thumb-repost-dcs-and-eqms

    Change Control — Continuous Quality Improvement in FDA and ISO Environments

    Besides cutthroat competition, manufacturers in the life sciences deal with strict regulatory and ISO quality requirements. Changes in processes need to be carefully managed to ensure that products stay safe and effective.

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  • 2020-bl-covid-19-the-cloud_132x132

    Why COVID-19 Is Driving Companies Toward the Cloud

    As the COVID-19 pandemic escalated, urgency and adaptability became the theme for organizations as they were suddenly tasked with enabling their entire workforce to work remotely. This scenario has largely been the impetus for more companies accelerating their migration to the cloud.

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  • 2019-bl-thumb-purpose-bulit-manufacturing-systems

    Understanding GxP Predicate Rules Is Key to Compliance With FDA 21 CFR Part 11

    FDA 21 CFR Part 11 does not invalidate the predicate rules that were established for paper-based document management systems, it simply builds upon and reinforces those existing rules in digital platforms. Learn about the symbiotic nature of Part 11 and FDA predicate rules and discover how an awareness of their relationship is fundamental to easing compliance burdens.

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