• Certification: Is It Worth the Hassle?

    12 August, 2014 by Lisa Weeks, Marketing Communications, MasterControl

    In the life sciences and other regulated industries, obtaining certification in a range of international standards has become a necessity for companies hoping to access and compete in today’s global marketplace. Whether your organization is a laboratory, medical device manufacturer, or automobile maker, becoming certified by an impartial third-party accreditation body assures potential customers that you value quality and your products conform to the highest regulatory standards. This assurance can lead to tremendous marketing and business advantages. But certification can be a long and trying process.

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  • Questions All Auditors Should Ask: The Use and Misuse of Audit Checklists

    31 July, 2014 by Laurie Meehan, Polaris Compliance Consultants, Inc.

    There’s nothing wrong with using a good checklist, as long as you remember that there will always be something wrong with your checklist. It is simply not possible to develop a checklist that will get to the core of every problem, that will cover every scenario, or that will ever be any reasonable substitute for that all important question: “Why?” So how can you develop the best checklists possible and avoid relying on them too heavily?

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  • Current Issues in Medical Device Risk Management

    29 July, 2014 by Edwin Bills, RAC Consultant

    Medical devices have been developed with some requirements for product safety since the implementation of the Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act.  Initially FDA required manufacturers to submit information related to safety as part of the 510(k) premarket notification process, providing comparative data on predicate devices versus the device under consideration.  In the more rigorous Premarket Approval (PMA) process, more detailed safety inform

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  • How the New FDA Final Rule and Guidance on Electronic Submissions Will Impact Devicemakers

    17 July, 2014 by Lisa Weeks, Marketing Communications, MasterControl

    In February of 2014, the FDA issued a final rule amending 21 C.F.R. Part 803, Medical Device Reporting, to require medical device manufacturers and importers to submit initial and supplemental MDRs in an electronic format, rather than in paper form through Form FDA 3500A. The “Final Rule” will take effect on August 14, 2015, which means you have only 13 months to revise your MDR procedures to comply with the new requirements and to secure a production account for submitting eMDRs to the FDA. Will you be ready?

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  • Listening and Being Heard are Important to Regulated Companies

    3 July, 2014 by Brian Curran, Senior Vice President, Product Management and Strategy, MasterControl Inc.

    If you’re wondering why your company should listen to your customers, or why as a customer you should be heard, just think of Twitter. Twitter and hashtags seem synonymous. But hashtags didn’t exist until a user suggested it in 2007. It took two years before Twitter, which was founded in 2006, started hyperlinking hashtags.

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  • Partnering with Quality Professionals Worldwide

    19 June, 2014 by Jon Beckstrand, CEO, MasterControl Inc.

    MasterControl has grown our reach significantly over the last 10 years—from a small provider of a narrowly focused document control product to one of the largest organizations in the world focused on helping quality and compliance professionals achieve their purpose. I have met with many of the world’s top quality professionals over the past 10 years and I have been amazed by their devotion and commitment. I have recently found myself asking the question: What drives these dedicated people? Why are they so passionate about their jobs? I believe I have found the answer and it has had a strong effect on how I view MasterControl’s mission.

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  • 3 Common Cybersecurity Mistakes in Pharma (and How to Avoid Them)

    17 June, 2014 by Jim King, Senior VP of Technical Support & Infrastructure, MasterControl Inc.

    Due to the ever-rising position of information as a valuable commodity, organizations must take steps to protect their data. For pharma and life sciences companies, the question is not if their digital data will be compromised, but when. Here are three common security mistakes made by enterprises and ways to avoid those mistakes by focusing on employee behavior.

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  • MasterControl Demonstrating Quality Management Software at MD&M East and DIA

    12 June, 2014 by Robyn Barnes, Marketing Communications, MasterControl Inc.

    June is the month for weddings and trade shows. Though we're not celebrating any nuptials, you’ll find MasterControl at MD&M East this week and at DIA the week of June 15.

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  • 7 Steps to CAPA Success

    10 June, 2014 by David R. Butcher, Marketing Communications, MasterControl

    A formal Corrective Action/Preventive Action (CAPA) can be a powerful tool for meeting current regulatory requirements. Done right, the systematic investigation of the root causes of identified problems or identified risks will prevent their occurrence or recurrence. For many companies, however, a crucial obstacle to CAPA success persists: adequate documentation of actions taken to achieve quality success.

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  • How Can You Measure the Return on Your QMS Investment?

    29 May, 2014 by James Jardine, Marketing Communications, MasterControl Inc.

    Every provider of electronic quality management systems claims its product will give you a significant return on your investment. But how can this ROI be truly measured? To find out, MasterControl recently surveyed customers to learn more about their levels of waste and efficiency before and after implementation of MasterControl's quality management system (QMS). Some of the results of the survey are compiled here in an informative infographic.

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  • How to Cut Your Document-Approval Cycle Time Using Escalation

    27 May, 2014 by Marty Jackson, Professional Services Consultant, MasterControl Inc.

    From SOPs and procedures to CAPAs and deviations, most regulated companies maintain document-based and form-based processes for compliance and business reasons. How do you get approval for your documents and forms? How many processes do you have and how long is your approval cycle time for each one?

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  • Ruined by Best Efforts

    22 May, 2014 by Craig Gygi, Executive Vice President, MasterControl Inc.

    When W. Edwards Deming famously said, “We are being ruined by ‘best efforts,’” he was conveying the idea that simply striving to improve—even with laudable effort—can actually have the opposite outcome. How can this be? How could good intentions and diligent work ever possibly sabotage us? Well, they do all the time.

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  • The Top 6 Pains in DHF Management

    20 May, 2014 by Matthew M. Lowe, Executive Vice President, MasterControl Inc.

    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.

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  • Understanding European Declarations of Conformity or Incorporation

    13 May, 2014 by Robyn Barnes, Marketing Communications, MasterControl Inc.

    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. 

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  • Conducting an Effective Failure Investigation: Going Deep Enough to Hit Root Cause

    24 April, 2014 by Christine Park, Quality Architech, Christine Park & Associates

    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.

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  • Principles of Lean Documents

    22 April, 2014 by José Ignacio Mora, Owner, Atzari Enterprises, L.L.C.

    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.

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  • Changing Supplier Controls Requirements

    26 March, 2014 by John E. Lincoln, J.E. Lincoln and Associates

    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.

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  • An Introduction to Metrics Collection and Usage

    20 March, 2014 by Christopher Ball, Senior Professional Services Consultant, MasterControl Inc.

    Most companies understand that the collection of data can be valuable but often don’t really rationalize what they want to collect.

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  • Sound Risk-Based Decision Making in Process Validation

    13 March, 2014 by Robyn Barnes, Marketing Communications, MasterControl Inc.

    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. “

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  • Be SMART: 5 Critical Factors in CAPA

    4 March, 2014 by Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    It’s not enough to come up with a corrective action for a quality event. It’s critical to have the right action that actually fixes the problem and prevents it from recurring.

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