• Compliance Data: A New Solution for Maintaining Cannabis Supply Continuity

    September 17, 2020 By Matt Dell, Acting Head of Marketing, Outspoke

    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.

    Full story
  • Change Control — Continuous Quality Improvement in FDA and ISO Environments

    September 16, 2020 By Jason Clegg, Marketing Director

    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.

    Full story
  • Why COVID-19 Is Driving Companies Toward the Cloud

    September 15, 2020 By David Jensen, Staff Writer

    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.

    Full story
  • Deviation and Change Control in Pharmaceutical Manufacturing

    September 10, 2020 by David Butcher, Staff Writer

    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.

    Full story
  • What Connected Quality Means for Training

    September 9, 2020 by Sarah Beale, Staff Writer

    For regulated companies, there’s a lot riding on training. If someone isn’t trained, the life-saving products of life sciences companies can become life-ending products. An integrated training management system gives training managers a complete picture of what’s going on with training and what they need to do next to stay on track.

    Full story
  • Quality Audit—A Tool for Continuous Improvement and Compliance

    September 4, 2020 By Jason Clegg, Director, Marketing Strategy

    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.

    Full story
  • The Fundamentals of Immunization, Part 2

    September 3, 2020 By Gina Guido-Redden, Co-Founder and COO, Coda Corp USA

    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.

    Full story
  • The Challenges of Cloud Compliance in a Regulated Environment

    September 2, 2020 by Kevin Grimes, Vice President, Arbour Group LLC

    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.

    Full story
  • The Supplier Audit Learning Curve

    August 31, 2020 By Sarah Beale, Staff Writer

    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.

    Full story
  • How to Approach Design Control From Both FDA and ISO Viewpoints

    August 28, 2020 by Peter Knauer, Managing Partner and Co-Founder of Sage BioPartners

    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.

    Full story
  • The Fundamentals of Immunization, Part 1

    August 27, 2020 By Gina Guido-Redden, Co-Founder and COO, Coda Corp USA

    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.

    Full story
  • Overview of ISO 13485 – Medical Device Quality Management System Requirements

    August 26, 2020 by James Jardine, Staff Writer

    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.

    Full story
  • New Ultimate Guide Presents In-Depth Look at Cloud Technology

    August 25, 2020 by David Jensen, Staff Writer

    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.

    Full story
  • Top 5 Shop Floor Safety Tips

    August 21, 2020 by James Jardine, Staff Writer, MasterControl

    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.

    Full story
  • Top 4 Reasons Why Documentation Reviews Are Critical to Compliance

    August 20, 2020 David Butcher, Staff Writer

    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.

    Full story
  • Unparalleled Paperless Manufacturing Solution Now Available Globally

    August 19, 2020 by James Jardine, Staff Writer, MasterControl

    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.

    Full story
  • EU’s MDR Calls for Summary of Safety and Clinical Performance

    August 18, 2020 by Dave Jensen, Staff Writer

    With the fast-approaching Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), medical device manufacturers will be seeing more documentation requirements. One of the new documents is a summary of safety and clinical performance (SSCP). This is one of the annual reports manufacturers must provide throughout the life cycle of a device in order to remain compliant to sell products in the EU.

    Full story
  • Digitization Drives Results for Contract Manufacturers

    August 14, 2020 by Dale Thompson, Staff Writer

    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.

    Full story
  • Integration Is the Fast Lane to Data

    August 13, 2020 by Sarah Beale, Staff Writer

    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.

    Full story
  • Answers to 7 Questions About Digitization and Configurability

    August 12, 2020 by Dale Thompson, Staff Writer

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

    Full story