GxP Lifeline
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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).

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • How to Meet FDA Remote Inspections Requirements with a Digitized QMS

    FDA Remote “Inspections” During the Pandemic

    Even during the pandemic, regulatory inspections must go on. The FDA favored some remote inspectional activities, but has not adopted remote inspections, per se. Mastering remote interactions with the FDA and remote audits require the same digital approach.

    Full story
  • Leveraging Your Manufacturing Software for Deviations

    A Robust Manufacturing Software Solution Reduces the Frequency and Impact of Deviations

    Deviations are an inevitable part of manufacturing, but the ability to detect and deal with deviations in real time, reduce the occurrence of avoidable deviations, and limit their impact is made more difficult than necessary with paper or disconnected systems. Manufacturers can save themselves a lot of pain by leveraging manufacturing software with robust digital tools to increase operational visibility and manage deviations more effectively.

    Full story
  • Top 10 most important capabilities an EQMS solution should have for medical device companies

    Medical Device Industry Guide to Selecting an EQMS Software

    If your medical device company is planning to implement quality management system software, you can’t afford to overlook the 10 most important capabilities an EQMS solution should have. Get the facts about EQMS software before you invest.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
[ { "key": "fid#1", "value": ["GxP Lifeline Blog"] } ]