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.
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.
August 28, 2020
By Peter Knauer, Managing Partner and Co-Founder, 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.
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.
August 25, 2020
By David Jensen, Staff Writer, MasterControl
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.
August 21, 2020
By James Jardine, GxP Lifeline Editor, 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.
August 20, 2020
By David Butcher, Staff Writer, MasterControl
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.
August 19, 2020
By James Jardine, GxP Lifeline Editor, 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.
August 14, 2020
By Dale Thompson, Staff Writer, MasterControl
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.
August 13, 2020
By Mike Rigert, Staff Writer, MasterControl
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.
August 13, 2020
By Sarah Beale, Staff Writer, MasterControl
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.
August 11, 2020
By James Jardine, GxP Lifeline Editor, MasterControl
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.
August 6, 2020
By Dale Thompson, Staff Writer, MasterControl
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.
August 4, 2020
By Debby Newslow President/Owner/Consultant/Auditor/Trainer/Speaker/Author at D L Newslow & Associates, and Sarah Beale, Staff Writer, MasterControl
Companies that were prepared with good quality management have fared better during the pandemic. ISO 9001 in particular has proved inadvertently helpful in adapting to disruption. To see how ISO connects to COVID-19, we spoke to Debby Newslow of D.L. Newslow & Associates.
July 30, 2020
By James Jardine, GxP Lifeline Editor, MasterControl
Whether you like it or not, you should brace yourself for Industry 5.0. The term refers to people working alongside robots and smart machines. If that definition brought to mind the image of Will Smith battling evil robots in the movie “I, Robot,” here are a few things you need to know about Industry 5.0.
July 28, 2020
By David Butcher, Staff Writer, MasterControl
The pandemic has highlighted the need for a faster, more flexible and scalable manufacturing environment that balances speed with compliance. While paper-based processes can slow production down or jeopardize quality, paperless production processes can streamline operations, reduce errors and readily leverage data critical to ensuring quality. A configurable, purpose-built electronic device history record (eDHR) application can be fast to implement and deliver quantifiable benefits.
July 27, 2020
By Sarah Beale, Staff Writer, MasterControl
How many times have you done something and immediately wished you could undo it? Or how many times have you wished you knew the outcome of something beforehand? Since time travel still eludes us, the best we can hope for is to try to fix our mistakes and anticipate future ones. In the regulated industry this is called corrective and preventive action (CAPA).
July 17, 2020
By Jason Orloff, Statistical & Engineering Consultant, Pharmstat
The tension between after-the-fact inspection and defect prevention has been at the heart of manufacture since the introduction of statistical methods to industry in the 1940s. Today, to clearly divide responsibilities within an organization, and tie these very different activities to existing roles, consider a division by impact to the patient. Activities which monitor a process in real-time to prevent defects while a lot is being manufactured are known as Statistical Process Controls (SPC).
July 17, 2020
By Brandwood CKC, and Belinda Dowsett, Quality Assurance Manager and Consultant
So much can change over a nearly 20 year period. Since the Australian Regulatory Framework for medical devices was adopted in 2002, the use and accessibility of software in medical applications has advanced beyond expectation.
