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GxP Lifeline
  • Medical Device DHF 21 CFR 820 Compliance

    Alleviating Headaches From 21 CFR 820 Design Control Compliance

    Compliant medical device design is governed by federal regulations along with competitive market needs. The essential aspects of a design control subsystem are outlined here, along with the most strenuous tasks related to design control, including design reviews. Converting from paper or hybrid quality management systems to an automated one can further reduce the challenges related to managing the Design History File (DHF) and help you to be ready for FDA inspections at any time.

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  • MasterControl’s ”Simplify your CAPA Process in 7 Steps” industry brief

    The CAPA Process Magnificent Seven

    Learn about seven ways to simplify your CAPA process by taking a closer look at the 1960s classic “The Magnificent Seven.”

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  • The relation between your OCM strategy and your eQMS success

    OCM and eQMS: Transformation or Conformance?

    The digitalization of quality processes can bring transformative change to an organization, but doing it right requires a sound strategy. Learn the four steps that form the foundation of a good organizational change management (OCM) plan.

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  • How a digital EQMS helps the pharmaceutical manufacturing industry overcome challenges.

    How Modern eQMS Solutions Are Powering Pharma’s Digital Revolution

    The increasing complexity, diversity, and personalization of pharmaceutical products has prompted companies throughout the industry to reevaluate their quality approaches. Discover how digital EQMS innovations are enabling leaders to overcome modern challenges.

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  • Collect, connect, and contextualize medical device manufacturing data through advanced technologies to leverage digitization.

    Medical Device Manufacturing Trends, Pt. 2: Digitize to Make Data Usable

    As the move toward digitizing manufacturing has accelerated, so has usage of the advanced technologies underlying digitization. Some of the most significant shifts include increases in cloud migration and use of advanced technologies in manufacturing operations to leverage digitization and better collect, connect, and contextualize data.

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  • 6 Data Integrity Questions to follow FDA Guidance for Pharma companies

    FDA Guidance Assists With Preventing Data Integrity Violations

    The U.S. Food and Drug Administration (FDA) has long emphasized the importance of the data integrity aspect of current good manufacturing practices (CGMP). Hoping to reduce data integrity violations, the agency drafted a question-and-answer-based guidance to clarify data integrity guidelines.

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  • A man explaining the difference between Quality Assurance, Quality Control and EQMS to a woman.

    The EQMS for Your Quality Assurance and Quality Control Systems

    Quality is an important part of doing business in regulatory environments. Enabling both quality control and quality assurance in an organization is vital. Learn how QA and QC play into quality management and how an enterprise quality management system simplifies them.

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  • Ensure QMS Compliance

    6 Ways to Ensure Your Quality Management System Meets FDA and ISO Compliance

    An optimal quality management system (QMS) is the foundation for long-term regulatory compliance, especially for organizations working within strict U.S. Food and Drug Administration (FDA) and International Organization for Standardization (ISO) environments. Following these six guidelines will help FDA-regulated and ISO-certified organizations optimize their QMS to ensure high-quality products and continuous compliance.

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  • How pharma companies avoid CAPA chaos and compliance issues with MasterControl’s smart CAPA management system.

    CAPA Overload and Other Perils to Avoid on Your Compliance Journey

    Managing corrective actions/preventive actions becomes overly burdensome for pharma companies when quality problems are escalated to CAPA regardless of their impact or scope. Learn a smarter approach that can help your organization avoid CAPA chaos and other obstacles you’ll face along the road to compliance.

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  • How to Improve decision making in your Quality Trend Analysis efforts.

    Trend Analysis on Quality Management: Improving Decision-Making With Timely Data

    You can’t make quality improvements without accurate, current, and meaningful data. But getting access to better process and performance data may require a different approach to quality trend analysis. Learn the answers to three critical questions about trend analysis in quality management.

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  • MasterControl’s computer system validation to maintain FDA compliance.

    5 Answers to FDA Computer System Validation Questions

    Computer system validation can drag on for months. However, it doesn’t have to. The FDA has indicated that a risk-based approach would reduce the validation burden while maintaining compliance.

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  • How to implement a Digital QMS with Quality 4.0 Principles

    OCM and a Digital QMS: Your Combination for a Competitive Edge

    Digitization enables companies to completely transform their quality processes, but simply going digital is only half the equation. Nancie Celini shows the importance of applying organizational change management and Quality 4.0 principles when implementing a digital QMS.

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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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  • 2021-bl-quality-assurance-quality-control_132x132

    Quality Assurance and Quality Control: What's the Difference When It Comes to Managing Quality?

    If you’re wondering what sets quality assurance apart from quality control, comparing the two functions to the roles in television’s longest-running police procedural may help you understand the distinction.

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  • Quality management review guidelines for medical device companies

    Quality Management Review for Compliance and Improvement

    The ultimate responsibility in a business lies at the top. In the regulatory world, this includes ensuring the quality system of a medical device company is effective. The specifics of how and how often the review should be conducted are a bit hard to pin down, but that’s by design. 21 CFR Part 820 has general guidelines, but leaves much of the “how to” up to individual companies.

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  • How to Overcome Supply Chain Challenges

    Pharma Supply Chains Call for Better Visibility

    Lately, it seems the only other term uttered as often as COVID-19 is supply chain. Global supply chains are largely becoming more complex, difficult to manage, and vulnerable to uncertainties and risks. This post addresses the supply chain challenges for pharmaceutical companies and provides tips for overcoming them.

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  • How to Choose the right Manufacturing software for life science companies.

    5 Key Areas for Life Sciences Manufacturers to Prioritize in Manufacturing Software

    Even as new technologies provide life sciences manufacturers with smarter, faster, and more cost-effective ways of improving production, choosing the right manufacturing software to transform production processes can be challenging. By determining the capabilities that fundamentally complement an organization’s quality manufacturing goals and current practices, manufacturers will be better prepared to choose the modern manufacturing execution software tools they need to succeed.

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  • How digitized MES and QMS help medical device manufacturing companies produce products for gene and cell therapies.

    Quality and Manufacturing System Implications for Cell and Gene Therapy

    With the significant advances in gene and cell therapies, companies producing breakthrough products are facing obstacles ranging from challenges with development to transitioning to commercial manufacturing. Solutions can be found in digital manufacturing execution systems (MES) and quality management systems (QMS).

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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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  • Differences between Quality Assurance, Quality Control and Quality Management for Life Sciences Manufacturing.

    Quality Assurance, Quality Control, and Quality Management Systems: Clarifying Confusion

    There are so many similar terms related to quality in the life sciences, it’s easy to get confused about their purposes and intersections. Learn the specific roles of quality assurance, quality control, and quality management, how they overlap, and the differences between each critical function.

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