December 21, 2023
By Ryan Coughlin, Vice President, Enterey Life Sciences Consulting
In the ever-changing business landscape, effective change management is crucial for organizational success. Companies must implement a well-thought-out process that not only anticipates inevitable changes but also addresses them in a positive and proactive manner. Enterey’s Ryan Coughlin offers tips on continuous process improvement.
Outsourced Pharma and Life Science Leader announced the CDMO leadership awards earlier this year. Digitization in manufacturing – a critical component for CDMOs that want to be at the forefront of innovation in their industry – plays a major role for all the winners. See which MasterControl customers made the list.
December 14, 2023
By Lars Mouritsen, President & CEO, Avendium, LLC
Effective supplier management is a linchpin for success in dynamic industries where product quality and regulatory compliance are non-negotiable. In this blog post, Avendium CEO Lars Mouritsen outlines the nuanced strategies and key components necessary to ensure a seamless and reliable supply chain.
December 13, 2023
By Matthew M. Lowe, Chief Product & Marketing Officer, MasterControl
In highly regulated industries like food, drugs, and medical devices, manufacturing companies must make big investments in people and products so they can avoid costly and damaging recalls. Find out why product recalls have spiked significantly in the past few years and what that means for manufacturers and consumers alike.
December 7, 2023
By Sunny Mak, International Team, planeus
In highly regulated environments, the effectiveness of a medical device product plan is often ignored – to manufacturers’ detriment. Learn how modern digital tools give manufacturers the power to not only ensure their medical device product plans are transparent and efficient, but also traceable and compliant.
December 6, 2023
By James Jardine, GxP Lifeline Editor, MasterControl
Effective corrective action/preventive action (CAPA) management isn’t just a regulatory requirement – it has a direct and measurable impact on product quality. If you want to optimize and simplify CAPA, these best practices provide the perfect starting point.
November 21, 2023
By Erika L. Roberts, MFS, Principal Consultant/Owner, ELR Lab Services LLC
Deviation management can be challenging – especially if your systems and processes aren’t connected. ELR Lab Services’ Erika Roberts offers a few tips on how to make managing deviations easier.
November 15, 2023
By Samantha Black, PhD, Head of Content, Elemental Machines
If you’re preparing to digitize manufacturing processes, the smartest approach is to learn from trailblazers’ experience. Read a recap of a conversation between Aspire Pharma’s VP of quality and Elemental Machines’ founder that shows how modern integrations are paving the way for comprehensive and transformative digital shifts in manufacturing.
November 8, 2023
By Steve Gompertz, Partner, QRx Partners
Process nonconformances often just seem to lead to longer, more prescriptive, and more complex documents. But longer and more complex doesn’t mean better. QRx Partners’ Steve Gompertz examines the many benefits that can be gained by taking a leaner, process-focused approach to documentation.
November 6, 2023
By James Jardine, GxP Lifeline Editor, MasterControl
This year’s World Quality Week, Nov. 6-10, offers the opportunity to realize your competitive potential. Join us in celebrating the masters of quality and sharing a few laughs about quality management professions.
November 2, 2023
By James Jardine, GxP Lifeline Editor, MasterControl
Quality professionals are all too familiar with having to shoehorn their organizations’ processes to fit the rigid functionality of their software systems. But those days are coming to an end. Find out how a revolutionary new tool is going to give quality leaders unprecedented control and forever change the way they manage quality events.
October 24, 2023
By David Jensen, Staff Writer, MasterControl
Digital manufacturing solutions, such as modern electronic batch records (EBRs), are key to optimizing your entire manufacturing operation and production staff. This post addresses key aspects of a good digital manufacturing solution and offers tips on choosing the right system.
October 19, 2023
By David Jensen, Staff Writer, MasterControl
All developers of regulated products know that every aspect of product development and manufacturing must be documented. To regulatory authorities, if it isn’t documented it didn’t happen. This post addresses regulatory oversight of documentation and identifies how document control software is a good springboard for a full digital transformation in quality management.
October 11, 2023
By Lars Mouritsen, President & CEO, Avendium, LLC
Quality and safety are the most important attributes of any product developed and sold by life sciences manufacturers. And supplier quality management plays a key role in ensuring both. In this blog post, Avendium CEO Lars Mouritsen examines the importance of supplier quality management, best practices, and its considerations and consequences in life sciences industries.
October 10, 2023
By Ave Love, Staff Writer, MasterControl
What will the digital landscape for quality professionals look like five years from now? Most likely, it will be centered on empowered quality professionals. Find out how configurable quality event management solutions are changing the face of quality by allowing quality professionals to capture and scale their expertise.
October 5, 2023
By David Jensen, Staff Writer, MasterControl
Research shows that both real and perceived obstacles are standing in the way of life sciences companies’ efforts to transition to digital manufacturing operations. While there may be a variety of blockers to digitization, there are ways to overcome them and improve operations. This post addresses the common obstacles to digitization and strategies for getting past them.
October 3, 2023
by Nicolle Medina, CTO and Co-Founder, Aligned Being LLC
A growth-oriented mindset facilitates trust and respect between quality and manufacturing teams. Find out how feedback and accountability lay the foundation for a culture of quality in life sciences organizations.
September 27, 2023
By Rai Chowdhary, CEO of KPI System (Key Performance Improvement)
Any decision made about a product is based on data, which means data errors and omissions can have significant negative impact. In this article, KPI System CEO Rai Chowdhary illuminates the need for more rigor on auditing of data, its analytics, and application of statistical methods.
September 26, 2023
By James Jardine, GxP Lifeline Editor, MasterControl
Success in pharma manufacturing hinges on effective recipe management. This blog post examines the challenges associated with recipe management in manufacturing and shows how modern digital manufacturing solutions can streamline processes, ensure compliance, and drive operational excellence.
September 20, 2023
By Rahul Kallampunathil, VP Digital Risk, Privacy, and Compliance, Arbour Group LLC
There are many views about what the FDA’s recent draft guidance on computer software assurance (CSA) means and how compliance with it differs from traditional approaches to computer software validation (CSV). Arbour Group’s Rahul Kallampunathil offers an in-depth look into what CSA entails and the benefits it provides.
