October 11, 2022
By Johanna Blair, Staff Writer, MasterControl
Quality events are inevitable, so it’s smart to use a CAPA management system. But, what constitutes a CAPA in the first place? Collecting nonconformance data with the right CAPA metrics can help you manage CAPAs more accurately and effectively — while avoiding future risk.
October 6, 2022
By Michelle Tanner, CFO, MasterControl
If you plan to delay technology investments to soften the recession’s blow, MasterControl CFO Michelle Tanner has news for you. Read on to get four recession survival tips and learn why those who don’t embrace advanced digital tools will lose ground in a down market.
October 4, 2022
By Kevin Ballard, Senior Project Manager, Validation on Demand, MasterControl
The FDA requires companies to validate software used in regulatory environments. But the processes involved in validation are usually a drain on your time and resources. By following six fundamental steps, you can adopt and validate software systems with greater ease.
September 29, 2022
By Lisa Helmonds, VP, Quality & Operations, AVS Life Sciences, and Myrna Russell, Director of Quality and Audit Management, MWA Consulting, Inc.
To ensure you’re able to manufacture high-quality products and safeguard patient safety and data integrity, your organization must be able to effectively manage supplier quality. Find out how taking a risk-based approach and applying modern tools can improve your supplier management capabilities.
September 28, 2022
By Brian Freymann, Director of Health Life Science & Strategic Accounts, Microexcel, Inc.
Criminal opportunists are making a killing off counterfeit versions of life sciences manufacturers’ products. Learn why serialization is the key to getting fake products off the market and ensuring consumer safety.
September 27, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
Streamlined production and quality processes are the keys to meeting the rising demand for cell and gene therapy manufacturing expertise and capacity. Find out how digitally bridging the gap between production and quality is helping companies thrive in the CGT space.
September 22, 2022
By David Butcher, Staff Writer, MasterControl
In fully or partially paper-based manufacturing environments, the production line is an underappreciated opportunity to make quality proactive rather than reactive. Digital technology in manufacturing can ensure quality at every step of production.
September 20, 2022
By Matthew M. Lowe, Chief Product & Marketing Officer, MasterControl
As medical devices have grown increasingly complex, the need for cybersecurity guidance has never been greater. The latest guidance from the U.S. Food and Drug Administration provides updates to earlier versions that manufacturers need to know.
September 15, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
When it comes to avoiding FDA Form 483s and getting 510(k) clearance for medical devices faster, Northeast Scientific has cracked the code. Find out how the leader in medical catheter reprocessing has fast-tracked regulatory success and eliminated lag points.
September 14, 2022
By Becky Blankenship, Technical Writer, Cannon Quality Group
Every medical device company is faced with the challenge of navigating the FDA’s quality system requirements. Cannon Quality Group shares four compliance best practices that help make the regulatory road less rocky.
September 8, 2022
By David Butcher, Staff Writer, MasterControl
ISO 9001:2015 is one of the most recognized standards in the world. Among the goals of the quality management system (QMS) standard is to enhance requirements for addressing QMS change management.
September 6, 2022
By Johanna Blair, Staff Writer, MasterControl
The scope of a quality management system (QMS) can look very different depending on the size and goals of a company. However, following ISO 9001 standards for documentation can benefit any system.
August 30, 2022
By Johanna Blair, Staff Writer, MasterControl
The FDA is paying more and more attention to life sciences companies data management deficiencies. Following these five suggestions can help your organization prevent data integrity failures and strengthen CGMP compliance.
August 25, 2022
By Brian Curran, Senior VP of Strategic Growth, MasterControl
While many manufacturers in medical technology manufacturing think they have an electronic device history record (eDHR) system, often it is incomplete because it still relies at least in part on paper. Whereas an incomplete eDHR system offers insufficient visibility, traceability, and data integrity, a complete eDHR solution enables smarter, faster manufacturing processes.
August 17, 2022
By James Jardine, GxP Lifeline Editor, MasterControl
Biopharma is rapidly becoming the most dynamic sector in the life sciences. But explosive growth brings new challenges in an industry dependent on contract manufacturing. Find out which market-changing trends you need to be aware of and what the future holds for biopharma contract manufacturers and their clients.
August 16, 2022
By Ave Love, Staff Writer, MasterControl
End-of-line quality control comes too late in a competitive market. Regulators have long emphasized the systematic integration of quality within manufacturing processes to yield safer and more efficient pharmaceuticals. Get clarity on the role of Quality by Design (QbD) in modern pharma manufacturing and learn why a purpose-built quality management system is the most effective means of implementing it.
August 11, 2022
By Johanna Blair, Staff Writer, MasterControl
Standard operating procedures (SOPs) are integral to successful quality management. However, they are not always the easiest to write or update. Learn how to improve compliance by building better procedural documents.
August 9, 2022
By Jaime Velez, Co-Founder, Operations & Quality Systems Improvement Experts (OQSIE)
Lack of visibility into quality operations can keep you from gleaning actionable information from data that’s already at your disposal. OQSIE’s Jaime Velez explains how document review templates can help your organization significantly improve performance and the quality of your products.
August 4, 2022
By David Jensen, Staff Writer, MasterControl
When a medical device fails to function as intended, it can potentially affect patient safety and brand reputation and even lead to a recall. With effective root cause analysis, organizations can more easily detect, resolve, and prevent problems.
August 4, 2022
By David Jensen, Staff Writer, MasterControl
There are numerous U.S. Food and Drug Administration (FDA) regulations surrounding data integrity. A good approach to maintaining data integrity compliance is to develop a practical data integrity plan for successful data management.
