Audits are never a fun experience, but you can greatly reduce the stress if you prepare beforehand. Passing your ISO 9001 audit is completely doable by following these steps.
April 13, 2023
By Bryan Ennis, Co-Founder & CEO, Sware
With innovative technologies accelerating the speed with which computer systems can be validated, the decision to shift gears into Validation 4.0 sounds like a no-brainer. So why do so many life sciences companies struggle to find a starting point for implementation? Sware founder and CEO Bryan Ennis offers a proven roadmap for modern computer system validation success.
April 6, 2023
By Ave Love, Staff Writer, MasterControl
It can be difficult to articulate what patient centricity means for pharma, let alone the benefits. Read this post to gain a clearer understanding of this relatively new approach to quality management, where it originates from, and practical ways to align your quality management system (QMS) with patient-centric principles.
April 4, 2023
By Johanna Blair, Staff Writer, MasterControl
Paperless automation makes the mundane tasks of our daily lives easier. It can be even more powerful when used on the shop floor. Replacing paper logbooks with electronic logbook software can bring not only greater efficiency for manufacturers, but also bring them closer to complete digital maturity.
March 31, 2023
By David Jensen, Staff Writer, MasterControl
At MasterControl, we wanted to determine the extent of digital maturity at life sciences companies in their manufacturing production management processes. We gained valuable insight from a survey of 152 life sciences companies worldwide in pharmaceutical, biotech, biologics, and medical device manufacturing. Find out how your organization can learn from the experience of others in overcoming production gaps.
March 29, 2023
By Becky Blankenship, Technical Writer, Cannon Quality Group
Medtech startups face countless obstacles in their quest to achieve compliance and get products to market. While most recognize that modern technologies will enable them to reach their goals faster, it can be difficult to know when the time is right to invest in new solutions. Read on to learn four good reasons why a medical device startup should implement an electronic quality management system (eQMS) sooner rather than later.
March 28, 2023
By Ave Love, Staff Writer, MasterControl
With the anticipated harmonization between the ISO 13485 standard and the U.S. Food and Drug Administration Quality System regulation (21 CFR Part 820) coming closer to fruition, it’s time for medical device designers and manufacturers to ask themselves a few questions, not the least of which being, “Am I ready?” and “What does it mean for me?” Another great one is this: “Is there a software solution that can make this easier?”
March 23, 2023
By Johanna Blair, Staff Writer, MasterControl
Discover five often overlooked steps that can make your next supplier quality audit a more productive experience. Gain the major benefit of superior visibility into supplier performance and keep your supply chain moving.
March 21, 2023
By Nancie E. Celini, DrPH, Organizational Change Management Leader, Think-OCM.org
Navigating and adapting to constant change requires more than a checklist mentality. Dr. Nancie Celini, president of Think OCM, explains why change management assessments must include mindful considerations and offers examples of the types of assessments that are ripe for a mindful approach.
March 16, 2023
By David Jensen, Staff Writer, MasterControl
To stay current with trends and gain a competitive edge in the life sciences market, manufacturing organizations collect a lot of data from various sources. For this level of data gathering, companies not only need more storage capacity, but they also need data storage technology that allows for rapid search and retrieval. Find out why industry leaders employ a data lake to store and manage large volumes of data.
March 15, 2023
By Steve Gompertz, Partner, QRx Partners
Regulators expect life sciences companies to take a risk-based approach to supplier management. But with so much supplier information to handle, how does an organization know which risks have been properly evaluated and controlled? QRx Partners’ Steve Gompertz examines the three critical phases of supplier management and explains how modern digital tools can streamline it.
March 14, 2023
By Sarah Beale, Staff Writer, MasterControl
Connectivity offers many potential benefits to medical devices. Unfortunately, that connectivity also presents risks. That’s why regulators are coming out with cybersecurity guidance documents for medical device manufacturers.
March 9, 2023
By James Jardine, GxP Lifeline Editor, MasterControl
In modern pharma manufacturing, the traditional, paper-based approach to managing production records and other essential documentation is too time-consuming and prone to errors to be effective. Find out eight ways electronic batch record (EBR) software can supercharge your operational efficiency.
March 7, 2023
By Ave Love, Staff Writer, MasterControl
If you haven’t already explored the benefits and necessities of artificial intelligence (AI) technology in pharmaceutical quality management, this is for you. The 2023 pharmaceutical industry trends show that applications of AI are increasing rapidly – and not a moment too soon. Unprecedented rates of vaccine development at the peak of the COVID crisis made the case for the value of life-sustaining AI technology. Are you there yet?
March 2, 2023
By Sarah Beale, Staff Writer, MasterControl
Digitizing is a difficult process that involves every department in an organization. At MasterControl, we conducted original research on where the life sciences industry stands in its QMS digitization efforts and how we can help you make progress on your journey and overcome these difficulties.
February 28, 2023
By Ross Stovall, Chief Corporate Systems Architect, CloudWorks4All
Regulatory agencies encourage companies to take a risk-based approach to validating their software systems. To help companies achieve that goal, CloudWorks4All’s Ross Stoval examines the steps involved in implementing a new, risk-based validation methodology. Read on to learn how risk-based validation practices help companies in the life sciences save time and effort while making it much easier to adopt cloud-based systems like modern electronic quality management systems.
February 23, 2023
By David Jensen, Staff Writer, MasterControl
Advanced technology has moved medical device innovation into the fast lane. It stands to reason that global regulatory agencies would step up to help keep the momentum going — and they have. In 2012, the International Medical Device Regulators Forum (IMDRF) rolled out the Medical Device Single Audit Program (MDSAP). This post details how the program works and how it continues to evolve.
February 21, 2023
By David Butcher, Staff Writer, MasterControl
If the U.S. Food and Drug Administration (FDA) called tomorrow to schedule a visit to your facility, would you panic or would you go on about your day, business as usual, knowing you have a robust FDA audit process in place?
February 16, 2023
By James Jardine, GxP Lifeline Editor, MasterControl
Total Quality Management (TQM) is based on the notion that an ounce of prevention is worth a pound of cure. But employees resist deviations from the status quo, which makes the implementation of TQM principles a challenge in most pharma manufacturing settings. Find out how three sensible steps that you can take today will create a foundation for TQM success tomorrow.
February 15, 2023
By Johanna Blair, Staff Writer, MasterControl
Cell and gene therapy (CGT) manufacturing offers unique challenges regarding good manufacturing practices (GMP). Are paper batch records efficient enough to remain compliant? Learn how digital manufacturing solutions can solve some of CGTs biggest production issues.
