• 2020-bl-change-pharma-mfg_thumb

    Deviation and Change Control in Pharmaceutical Manufacturing

    In pharmaceutical manufacturing environments, strict compliance to approved policies and procedures is essential to keep manufacturing operations in a state of control. Uncontrolled changes like deviations can affect the safety and reliability of products, not to mention the regulatory status of products, directly affecting public health and safety. This is what makes change control – and a paperless system – crucial.

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  • 2020-bl-cloud-ultimate-guide2_132x132

    Cloud-based QMS Launches in Australia

    MasterControl’s cloud-based quality management system (QMS) is now available in Australia. An increasing number of businesses are modernising their operations and discovering the advantages of cloud computing. Explore the ways cloud technology makes it possible to enhance your competitive edge.

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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-coda-corp-vaccines_132x132

    The Fundamentals of Immunization, Part 2

    The race to develop a safe and effective vaccine against COVID-19 is on, and it has everyone talking. This is the second of a three-part series on the fundamentals of immunization.

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  • 2020-bl-arbour-day-group_thumb

    The Challenges of Cloud Compliance in a Regulated Environment

    Life sciences companies are migrating the cloud. To be successful with cloud compliance in a regulated environment, it’s important to understand the key challenges and know how to address them. While cloud host providers offer security features, it is your organization’s responsibility to confirm the provider is compliant.

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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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  • 2018-bl-thumb-how-to-approach-design-control

    How to Approach Design Control From Both FDA and ISO Viewpoints

    Design control plays a key role in producing a successful medical device or IVD tool in initial development and through its lifecycle. Learn some tips on how to approach a design control strategy from either FDA or ISO perspectives.

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  • 2020-bl-coda-corp-vaccines_132x132

    The Fundamentals of Immunization, Part 1

    The race to develop a safe and effective vaccine against COVID-19 is on, and it has everyone talking. Inoculation,vaccination and immunization are terms that are often used interchangeably, but have very different meanings.

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  • 2020-bl-iso-13485_132x132

    Overview of ISO 13485 – Medical Device Quality Management System Requirements

    Medical device manufacturers tout ISO 13485 certification as proof that their quality management systems (QMS) and products are up to snuff. But what does compliance to the standard entail? Get answers to the most frequently asked questions about the world’s most widely used QMS standard for device companies.

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  • 2020-bl-quality-architech_132x132

    New Ultimate Guide Presents In-Depth Look at Cloud Technology

    Discoveries and new opportunities are expanding across the industrial spectrum. At the same time, more businesses are modernizing their operations to benefit from scientific and technology innovation. The core of all this progress and growth is the cloud.

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  • factory-engineers-quality-assurance-132

    Top 5 Shop Floor Safety Tips

    Optimizing shop floor safety practices is as straightforward as abiding by five fundamental manufacturing safety tips. Learn how the right ideology can enable a manufacturer to establish effective shop floor safety practices and extend a safety-centered mindset across the entire enterprise.

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  • 2020-bl-thumb-4-reasons-documentation-is-critical_thumnb

    Top 4 Reasons Why Documentation Reviews Are Critical to Compliance

    When was the last time you reviewed your quality documents? If you don’t review them, how do you know if you need to update and revise them? These are the questions that Marty Jackson1, a MasterControl professional services consultant, asks new clients who are switching from a paper-based document management process to an automated system. In most cases, they are stumped.

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  • 2020-bl-asia-launch-announcement_132x132

    Unparalleled Paperless Manufacturing Solution Now Available Globally

    A game-changing software solution that allows manufacturers to digitally connect and gain control of their data and documentation is now available globally and in 10 different languges. Learn how companies around the world are bridging the gap between operational excellence and smart manufacturing.

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  • 2020-bl-cmo-metrics-that-matter_132x132

    Digitization Drives Results for Contract Manufacturers

    Contract manufacturing and packaging organizations adopted MasterControl’s Manufacturing Excellence™ and saw significant results including increased production capacity, transparency for customer audits, and faster time to market. Read more about our customers seeing improvements in metrics that matter.

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  • 2019-bl-thumb-how-the-tga-regulates-drugs-and-devices

    Australia Offers Wave of Potential for Pharma, Medical Device Manufacturers

    Gathering momentum and power like a monster wave, Australia's life sciences sector is increasingly becoming a beacon for pharmaceutical and medical device manufacturers seeking regulatory approval for their products.

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  • 2020-bl-ipass-integration_132x132

    Integration Is the Fast Lane to Data

    A platform approach is the ideal way to handle software solutions across an organization. However, no software provider has every type of software that a company might need. That’s why integration platform as a service (iPaaS) is so vital. It bridges the gap between solutions and gives you better control over your data.

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  • 2020-bl-thumb-manufacturing-tech-trends-accelerate-time-to-market

    Answers to 7 Questions About Digitization and Configurability

    In our Q&A with Product Manager Katie Farley, she explains why digitization and configurability are critical to manufacturing.

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  • 2020-bl-proactive-predictive-quality_132x132-thumbnail

    How to Shift From Proactive to Predictive Quality Data Management

    The reluctance to abandon conventional paper-based quality management systems (QMS) has long typified the life sciences industry’s approach to quality. Familiar yet inefficient quality models are shortsighted, however.

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  • 2020-bl-fda-guidance_132x132

    FDA Sets Out to Curb Data Integrity Violations With Guidance on Data Handling

    Noticing an increase in violations of current good manufacturing practices (CGMP) regarding data integrity, the U.S. Food and Drug Administration (FDA) drafted a question-and-answer-based guidance to address some of the frequently asked questions and to clarify the role of data integrity in regulated product manufacturing.

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  • 2020-bl-digitization-workers_132x132

    Digitization Enhances Rather Than Replaces Workers

    Automation and digitization are rapidly becoming the norm for life sciences companies. While some people are concerned new technologies will replace workers, Mike Ferletic, President and CEO of Enterey, believes the opposite.

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