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GxP Lifeline
  • 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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  • annex11-vs-part11_132x132

    Understanding the Differences Between EU’s Annex 11 and FDA’s 21 CFR Part 11

    With manufacturers digitizing at a rapid rate, understanding the core of the European Union’s (EU) guidelines, Annex 11, and its approximate FDA counterpart, 21 CFR Part 11, is more critical than ever. They are central to understanding the conditions for life sciences manufacturers’ electronic data in the EU and the U.S., and while the guidance is similar in both countries, it’s important to understand the key differences.

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  • 2021-bl-fda-warning_132x132

    Prelude to an FDA Warning Letter

    Receiving a warning letter involves action items and additional correspondence with the U.S. Food and Drug Administration (FDA). All of which delays your company in getting product out the door. Learn some of the common reasons life sciences companies receive FDA warning letters, so you can avoid making the same mistakes.

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  • 2021-bl-steps-to-capa-success_132x132

    7 CAPA Process Steps to Ensure CAPA Success

    Inadequate quality management and poor data can be costly for a life sciences company or similarly regulated industry. However, a strong corrective action/preventive action (CAPA) program paired with a digital CAPA management tool can help differentiate your company from the competition.

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  • quality-control-approval-with-abstract-background-132

    Life Sciences Start-Ups: What You Need to Know About Phase Appropriate Quality Requirements

    Whether your start up company makes pharmaceutical products, biologics, or medical devices, you all have one thing in common. You need to implement a robust digital quality management system (QMS) at the early phase of product development to comply with the ever changing and more stringent regulations throughout the product life cycle.

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  • 2020-bl-author-brian-curran

    How Electronic Batch Records and Device History Records Close the Digital Manufacturing Gap

    To support advanced data technologies and to compete in a modern market, manufacturers must close the digital gap on the shop floor, where critical production processes remain paper-based and disconnected. Digitizing the paper-based production record process can close this gap by creating productive connections between people, processes, and systems throughout the manufacturing process and across the entire enterprise for a holistic view of production data.

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  • 2021-bl-validation_132x132

    Simplifying Commercial Software Validation in Medtech Manufacturing

    Validation has historically been a time-consuming, painful undertaking for medtech companies that depend on commercial off-the-shelf software solutions. As that the bulk of that burden shifts away from users and onto software providers, it’s getting easier to take a risk-based approach to validation.

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  • 2021-bl-sop-review_132x132

    FDA Inspection Preparation: SOPs, Process Maps, and Gap Analysis

    With proper preparation and the right tools, a manufacturing organization can always be ready to pass a U.S. Food and Drug Administration (FDA) inspection relatively stress-free. Process mapping and gap analysis can help manufacturers not only show the FDA that a company is compliant with regulatory expectations, but also help demonstrate that standard operating procedures (SOPs) are correct and that employees understand them.

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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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  • 2021-bl-iso-standards_132x132

    ISO Standards: Turning Hopes Into True Quality Objectives

    Don’t settle for ambiguous quality goals when you need measurable objectives that truly affect outcomes. Learn how alignment with ISO standards can turn your wishes into real quality improvements.

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  • scientists-working-on-a-digital-touch-screen-in-lab-132

    Regulatory Records Primer: Decoding the Requirements for Medical Device Manufacturers

    The U.S. Food and Drug Administration (FDA) set up the Quality System Regulation (QSR) to give medical device companies guidelines for ensuring quality, safety, and efficacy of their devices. There are many components to the QSR, but this post focuses on the requirements that apply to records.

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  • 2021-bl-risk-based-approach-suppliers_132x132

    The Role of Supply Agreements in Life Sciences Manufacturing

    In light of the COVID-19 pandemic’s disruption to the global supply chain and the urgency around manufacturers quickly delivering life-saving products, it makes sense that manufacturing organizations and their supply partners might reassess their relationships and obligations to one another to manage the results of disruption to supply chain partners.

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  • 2021-bl-supplier-scorecard_132x132

    How to Develop an Effective Supplier Scorecard

    Supplier performance greatly affects the cost, quality, delivery, and responsiveness of a manufacturer’s business. For any manufacturer whose product quality relies in part on a supplier’s own product or service, the organization must be able to ensure or improve high supplier performance. Supplier scorecards are a logical place to start.

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  • 2021-bl-executive-backing-digital-qms_132x132

    Tips to Gain Executive Support for a Digital QMS

    Persuade executives to support your efforts to adopt a digital quality management system (QMS) by speaking to their pain points around costs.

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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-systems-used-clinical-trials_132x132

    5 Things to Know When Using Computerized Systems in Clinical Trials

    Innovative streamlining technologies like the cloud are transforming the way clinical trials are conducted and monitored. If you want to stay in the FDA’s good graces, there are five key elements you need to understand when using digital tools in your clinical activities.

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  • 2021-bl-prevent-data-integrity-issues_132x132

    Identifying and Preventing Common Data Integrity Issues

    Current good manufacturing practices (CGMPs) are minimum requirements that companies must meet in developing health care-related products. Data integrity plays a key role in all areas of GMP compliance. This post provides tips on developing a data management strategy to ensure ongoing compliance with data integrity guidelines.

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  • 2021-bl-design-for-compliance_132x132

    How to Design for Compliance: Tips for Getting (and Keeping) Your New Product on the Market

    The FDA continues to endeavor to reduce the regulatory burden on medical device manufacturers. Still, devices need to make the trek through the regulatory pathway to achieve market approval. This post details how medtech companies can achieve successful product compliance and a faster market launch.

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