December 16, 2021
By Sarah Beale, Staff Writer, MasterControl
Artificial intelligence (AI) in health care has enormous potential, but AI-enabled software as a medical device (SaMD) is charting new territory. Last year, regulators indicated some of their priorities for AI in SaMD and what regulations might look like in the future.
December 14, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
FDA and other regulators are increasingly cracking down on pharma companies’ data integrity lapses. Learn the fundamentals of maximizing data usage that will help keep your quality and compliance activities aligned with regulatory expectations.
December 9, 2021
By David Butcher, Staff Writer, MasterControl
As the field of personalized medicine grows and evolves, and regulatory agencies such as the U.S. Food and Drug Administration (FDA) take steps to address regulatory oversight in the field, affected organizations should brace themselves for change and use it to their advantage. Here are three ways that companies in personalized medicine can approach regulatory obstacles as opportunities instead.
December 8, 2021
by Mike Rigert, Staff Writer, MasterControl
With manufacturers digitizing at a rapid rate, understanding the core of the European Union’s (EU) guidelines, Annex 11, and its approximate FDA counterpart, 21 CFR Part 11, is more critical than ever. They are central to understanding the conditions for life sciences manufacturers’ electronic data in the EU and the U.S., and while the guidance is similar in both countries, it’s important to understand the key differences.
December 7, 2021
By David Jensen, Staff Writer, MasterControl
Receiving a warning letter involves action items and additional correspondence with the U.S. Food and Drug Administration (FDA). All of which delays your company in getting product out the door. Learn some of the common reasons life sciences companies receive FDA warning letters, so you can avoid making the same mistakes.
Inadequate quality management and poor data can be costly for a life sciences company or similarly regulated industry. However, a strong corrective action/preventive action (CAPA) program paired with a digital CAPA management tool can help differentiate your company from the competition.
December 2, 2021
By Lisa Helmonds, VP, Quality & Operations, AVS Life Sciences, and Paul Andrea, Independent Consultant, MWA Consulting, Inc.
Whether your start up company makes pharmaceutical products, biologics, or medical devices, you all have one thing in common. You need to implement a robust digital quality management system (QMS) at the early phase of product development to comply with the ever changing and more stringent regulations throughout the product life cycle.
November 18, 2021
By Brian Curran, Senior VP of Strategic Growth, MasterControl
To support advanced data technologies and to compete in a modern market, manufacturers must close the digital gap on the shop floor, where critical production processes remain paper-based and disconnected. Digitizing the paper-based production record process can close this gap by creating productive connections between people, processes, and systems throughout the manufacturing process and across the entire enterprise for a holistic view of production data.
November 17, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Validation has historically been a time-consuming, painful undertaking for medtech companies that depend on commercial off-the-shelf software solutions. As that the bulk of that burden shifts away from users and onto software providers, it’s getting easier to take a risk-based approach to validation.
November 16, 2021
By David Butcher, Staff Writer, MasterControl
With proper preparation and the right tools, a manufacturing organization can always be ready to pass a U.S. Food and Drug Administration (FDA) inspection relatively stress-free. Process mapping and gap analysis can help manufacturers not only show the FDA that a company is compliant with regulatory expectations, but also help demonstrate that standard operating procedures (SOPs) are correct and that employees understand them.
November 11, 2021
By James Irons, Director of Strategic Development, and Samir Patel, Project Lead - Digital Systems, Sequence
The pharmaceutical manufacturing industry resists digitization and continues to rely on paper as a single source of truth for record keeping. This outdated process is inefficient and can actually create more risk in the long run. Understand the primary causes of resistance to digitization and how to address those barriers.
November 9, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Don’t settle for ambiguous quality goals when you need measurable objectives that truly affect outcomes. Learn how alignment with ISO standards can turn your wishes into real quality improvements.
November 4, 2021
By David Jensen, Staff Writer, MasterControl
The U.S. Food and Drug Administration (FDA) set up the Quality System Regulation (QSR) to give medical device companies guidelines for ensuring quality, safety, and efficacy of their devices. There are many components to the QSR, but this post focuses on the requirements that apply to records.
November 2, 2021
By David Butcher, Staff Writer, MasterControl
In light of the COVID-19 pandemic’s disruption to the global supply chain and the urgency around manufacturers quickly delivering life-saving products, it makes sense that manufacturing organizations and their supply partners might reassess their relationships and obligations to one another to manage the results of disruption to supply chain partners.
October 28, 2021
By David Butcher, Staff Writer, MasterControl
Supplier performance greatly affects the cost, quality, delivery, and responsiveness of a manufacturer’s business. For any manufacturer whose product quality relies in part on a supplier’s own product or service, the organization must be able to ensure or improve high supplier performance. Supplier scorecards are a logical place to start.
October 12, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Form 483 inspectional observation reports from the FDA result in painful and costly nightmares for pharmaceutical companies. Learn the top five reasons the agency issues Form 483s and find out best practices for steering clear of them.
September 30, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Innovative streamlining technologies like the cloud are transforming the way clinical trials are conducted and monitored. If you want to stay in the FDA’s good graces, there are five key elements you need to understand when using digital tools in your clinical activities.
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.
September 27, 2021
By David Jensen, Staff Writer, MasterControl
The FDA continues to endeavor to reduce the regulatory burden on medical device manufacturers. Still, devices need to make the trek through the regulatory pathway to achieve market approval. This post details how medtech companies can achieve successful product compliance and a faster market launch.
