September 28, 2021
By David Jensen, Staff Writer, MasterControl
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.
August 6, 2021
By David Butcher, Staff Writer, MasterControl
Life sciences manufacturers' production processes should be assets, not liabilities. Yet too many manufacturing companies continue to allow their batch records to become liabilities by using manual, often paper-based systems that are error-prone, disconnected, and limited in the operational insights they provide. Here are three common batch record challenges manufacturers encounter and some practical ways an electronic batch record (EBR) solution can resolve them.
July 15, 2021
By James Jardine, Staff Writer, MasterControl
Quality takes on a new meaning in the clinical manufacturing sector, where flexibility is critical and production hinges on rapid yet exacting adjustments. Discover how integrating quality early in the manufacturing process gives companies an edge in the fast-paced and highly competitive field.
July 6, 2021
By Dale Thompson, Staff Writer, MasterControl
Between helping to deliver a vaccine to the world, and rising demands in personalized medicine, the contract manufacturing industry is traveling fast, but the market requires more. Digitization makes it possible to accelerate while delivering high-quality products to the market faster.
May 27, 2021
By David Butcher, Staff Writer, MasterControl
As manufacturers continue to work through COVID-19 challenges and beyond, they must focus on ensuring workforce safety and productivity on the shop floor while enabling a connected, productive workforce that may be partly remote – and need to do so in ways that keep employees safe. A recent webinar with MasterControl SVP of Strategic Growth Brian Curran and Product Manager Katie Farley discussed some production challenges revealed by COVID-19, and reasons to digitize.
May 11, 2021
By David Butcher, Staff Writer, MasterControl
The movement toward digitization in manufacturing isn’t new, but the events of 2020 forced many organizations to adopt digital solutions quicker than previously planned. The digital changes that companies made over the past year are likely to remain after the crisis. As manufacturers look for ways to leverage technology to improve operations, they should consider at the following four ways to apply digitization.
March 30, 2021
By Dale Thompson, Staff Writer, MasterControl
In the growing field of personalized medicine, there are significant opportunities for contract manufacturers, and the challenge to keep up with demand can be met by adopting the right technology.
March 24, 2021
By David Butcher, Staff Writer, MasterControl
Since its founding in 1978, medical device manufacturer Weaver and Company has grown, regulations relevant to its products have evolved, and paper-based processes posed greater risk. Recognizing that managing paper quality and production documents was no longer practical, the Colorado-based company has taken steps to modernize with MasterControl's digital quality management and manufacturing solutions.
March 18, 2021
By Dirk Stynen, Ph. D., President and Principal Consultant, Qarad BV
Electronic distribution of instructions for use (eIFU) are becoming widely used among medical device manufacturers. Due to the increasing popularity, it is critical to understand eIFU within the context of regulations, particularly Europe’s new medical device regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
March 16, 2021
By Jon Beckstrand, CEO, MasterControl
We have built technology for life sciences quality and manufacturing for more than 25 years and I have been involved in that effort for 19 years. It wasn’t until 2014 that we realized the why behind what we do and it wasn’t until 2020 that our mission became crystal clear to everyone on our teams.
February 23, 2021
By Nicolle Cannon, Founder & CEO, Cannon Quality Group
Last year brough a lot of changes to audits. In addition to remote audits, MedTech suppliers are learning the value of shared audit to be beneficial in working down the backlog of audit requests while reducing exposure in the plant.
February 22, 2021
By Managing Director, Qualitech Engineering and Compliance
AI is moving quickly, and before long, it will play an integral role in the pharmaceutical sector. The benefits of AI include improving efficiency, streamlining production, and shortening the length of time it takes to conduct quality reviews. The result is getting product to market faster.
February 10, 2021
By Dale Thompson, Staff Writer, MasterControl
The president of Wellington Foods, a leading contract manufacturer of nutraceuticals, explains why quality should be an organization’s top priority. This approach helps manufacturers achieve better process control and plan for significant growth without worrying about highly complex manufacturing processes.
January 7, 2021
By James Jardine, Staff Writer, MasterControl
In the wake of a global pandemic, supply chain disruptions that were once inconveniences have become existential threats to many life sciences companies. Learn the steps your organization can take to build a more resilient supplier ecosystem.
December 17, 2020
By Dale Thompson, Staff Writer, MasterControl
Integrate disparate systems and get the most out of your investment in technology designed to streamline manufacturing operations. This will make it possible to improve efficiency, eliminate mistakes and scale quickly.
December 14, 2020
By Dale Thompson, Staff Writer, MasterControl
Every day, we use technology to make our lives easier. Similar technology is available to streamline manufacturing processes. It’s time to digitize and make production errorless, visible and connected.
December 9, 2020
By Sarah Beale, Staff Writer, MasterControl
We recently sat down with North Pole CEO Kris Kringle to chat about how he took his operation from paper to digital. Turns out making presents for children all over the world requires a cutting-edge manufacturing solution.
November 18, 2020
By David Butcher, Staff Writer, MasterControl
Additive manufacturing (AM), often referred to as 3D printing, is frequently used for product research and development in many industries and for commercial production in some, including medical device manufacturing. In the medical device industry, it is expected to grow fast, offering significant value in the production of customized, fast-to-market devices.
November 12, 2020
By Sarah Beale, Staff Writer, MasterControl
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.
