.jpg?sfvrsn=8c2c1c58_0 "2014-blog-article-image-risk-based-decision-(3)")
There were so many people everywhere you went that it felt like a real crush. I’ve got to tell you that a foot massage every night would have been really useful. “
Full story
In a tough economy, quality professions often find themselves having to convince management that swapping their paper-based QMS for an electronic one is worthy of the expense and will translate into bottom-line, as well as compliance, benefits. While the regulatory and legal drivers for automating your quality processes are irrefutable, the frequently overlooked operational and business opportunities enjoyed by organizations that implement an electronic QMS are equally compelling. Simply put: compliance is good for business, and the right QMS software can help you transform your compliance challenges into tangible business advantages.
Full story.jpg?sfvrsn=e05b6fa4_0 "2014-bl-ballmetric-blog-page-image-(3)")
Most companies understand that the collection of data can be valuable but often don’t really rationalize what they want to collect.
Full story
In the second webinar of a three-part series from MasterControl, quality expert Ken Peterson demonstrates how companies can develop better corrective and preventive actions (CAPA) to ensure quality and compliance. In the second installment, Peterson focuses on key decision points and the types of actions that should be taken depending on the quality event. He points out the importance of containing issues at the department level, if possible, before moving them into a formal CAPA process. Peterson discusses four possible actions to be taken when dealing with quality events: no action (the “wait and see” approach), corrections (with a focus on the immediate situation or containment), corrective actions, and preventive actions (to preemptively deter issues from occurring in the future).
Full story
Companies that choose to produce medical products come under the regulatory laws of the countries in which they market their products. For the U.S., this falls under the purview of the U.S. FDA, with its CGMPs, “Current [best practices] Good Manufacturing Practices”, as codified in 21 CFR 4, Combination Products, 21 CFR 111, Dietary Supplements, 21 CFR 211, Pharmaceuticals, and 21 CFR 820, Medical Devices, and others.
Full story
MasterControl will provide demonstrations of its document management and quality management solutions at the 30th Society for Quality Assurance (SQA) Annual Meeting to be held April 6-11, 2014 at the Cosmopolitan of Las Vegas in Las Vegas, Nevada.
Full story
A previous blog post provided an overview of a portion of quality guru Ken Peterson’s “Taking Effective Action” webinar (the second of a three-part series) that outlines the keys to successful CAPA programs. This post summarizes the remainder of the second webinar in the series which can be viewed here.
Full story.jpg?sfvrsn=330f96bb_0 "magnifying-fda-1-(4)")
We present a summary of available options to request additional review of FDA decisions or actions, including how to choose an option when a stakeholder has reasonable grounds to disagree with FDA/CDRH’s decision. It is worthwhile to note and get familiarized with the available options. However, it is recommended the stakeholder try to avoid having such situations in the first place.
Full story.jpg?sfvrsn=c97594b4_0 "2014-bl-audit-response-page-image-(3)")
After writing, revising, and signing the finalized audit report, most independent auditors move on to their next project.
Full story.jpg?sfvrsn=58fdd05b_0 "2014-bl-thumb-pass-fail-(3)")
More and more regulated companies are using electronic quality management systems, but the concept of software validation remains a mystery to many engineers and quality professionals. In this article, I will try to shed light on the underlying goal of software validation within the context of FDA guidelines and offer a practical strategy.
Full story.jpg?sfvrsn=dbc1f524_0 "2014-nl-main-inline-image-mdmw-logo-(3)"){kind=logo}
I recently had the opportunity to chair a track and present a session on FDA and a Global Regulation in Practice at the MD&M West Conferen Trouble-Free Validation with MasterControl (1:38)ce. The conference was held at the Anaheim a Convention Center from Monday, February 10th through Thursday February 13th, 2014. Below is a summary of the proceedings for Day 2: NAVIGATING THROUGH THE PMA AND 510(K) SUBMISSION PROCESSES.
Full story
The ability to adapt to change is critical to the success of any business. However, for companies that operate in FDA-regulated or ISO-certified environments, adapting to change and more importantly, being able to control it, is critical to maintaining compliance. Of course, it’s not just regulatory agencies that are demanding higher-quality products; today’s more sophisticated consumers expect the medicines, automobiles, and devices they purchase to be safe and effective, too. They also expect them to cost less and be developed more quickly and efficiently. Better, safer, faster, cheaper…it’s a tall order for any regulated company. Organizations that respond quickly to increased regulation and consumer sophistication will become inherent market leaders. How does your company respond to change?
Full story.jpg?sfvrsn=8e4acc94_0 "2014-bl-menu-page-image-(3)")
Many would chuckle at this story as a simplistic analogy. Yet, there are many lessons from this example that could apply to a medical device facility. No, it’s not a controlled document in the sense most understand it. But the owner would not want it to be this morning’s breakfast menu during dinner, or to display last year’s prices. Nor would she want it to show meal options that are not available.
Full story.jpg?sfvrsn=e840de2a_0 "2014-bl-the-problem-page-image-(3)")
The FDA has increased focus on the effectiveness of failure investigations during recent inspections. A review of recent 483 observations and warning letters clearly demonstrate the agency’s current concern about the adequacy of failure investigations to really identify root cause.
Full story.jpg?sfvrsn=688977e8_0 "2014-bl-gygi-philosophy-page-image-(3)")
A few years back, I helped an international holding company assess the operations of their portfolio of companies. They wanted to know things like, “How Lean is the operation at each company?” “How far along is each company in its Six Sigma improvement journey?” And “What are the common opportunities and strengths we can build upon?” I visited company sites, reviewed operation activities, collected data, and interviewed executives and staff. I found that in many ways, the foundation for excellence in operations can be boiled down to a single, simple question: “How do you define quality?”
Full story.jpg?sfvrsn=8a640bf0_0 "2014-bl-follow-the-trail-2-page-image-(3)")
One of the most effective audits I ever participated in started with a systems-naive auditor asking a simple question: "Imagine I'm a sample arriving at your loading dock. What happens to me?" We proceeded down the trail together, following the sample through the processes of accessioning, analysis, reporting, and storage.
Full story
Whether we’re practicing Lean or Six Sigma, what we’re really targeting is process improvement. The process could be technical, commercial, or a support-process to the standard order-to-delivery process within the context of our manufacturing environment. All too often, manufacturing executives mistake a sequence of activities to be a process. That’s simply not the case. So, what makes a good process?
Full story.jpg?sfvrsn=6f5e9bc_0 "2014-bl-drowning-paper-page-image-(3)")
In the past 10 years that I’ve been working with highly regulated companies, I’ve seen many organizations find out the hard way that quality does not occur by accident. Quality requires good planning, design, and execution.
Full story.jpg?sfvrsn=f5fd6983_0 "2014-bl-ce-page-image-(3)")
In the wonderful world of medical device regulation, a manufacturer may find it easy to become confused with FDA rules. When your product moves to the international market, there are new rules that must be followed to get your product to market.
Full story.jpg?sfvrsn=9e9c1c52_0 "2014-bl-thumb-why-cartoon-(3)")
In my experience working in medical device product development and product management, maintaining the design history file (DHF) posed daunting challenges because it was a process that continued throughout the lifecycle of a product. Even years after a medical device is launched, it’s not uncommon for the technical lead to revisit the DHF because the product is undergoing an iteration or it’s being launched in another part of the world.
Full storyWe use cookies to make interactions with our website more meaningful, to better understand how people use the site, and to tailor advertising. You can read more about how we use cookies here.