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Showing items tagged as Change Control

  • Change Control — Continuous Quality Improvement in FDA and ISO Environments

    September 16, 2020 By Jason Clegg, Marketing Director

    Besides cutthroat competition, manufacturers in the life sciences deal with strict regulatory and ISO quality requirements. Changes in processes need to be carefully managed to ensure that products stay safe and effective.

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  • Deviation and Change Control in Pharmaceutical Manufacturing

    September 10, 2020 by David Butcher, Staff Writer

    In pharmaceutical manufacturing environments, strict compliance to approved policies and procedures is essential to keep manufacturing operations in a state of control. Uncontrolled changes like deviations can affect the safety and reliability of products, not to mention the regulatory status of products, directly affecting public health and safety. This is what makes change control – and a paperless system – crucial.

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  • How Cloud Migration Has Become More Seamless for Regulated Companies

    October 8, 2019 by David Jensen, Staff Writer, Master Control

    Cloud technology has reached a level of maturity where many regulated companies are discovering that operating in the cloud is more cost effective and a competitive advantage. A new white paper discusses the benefits of moving to the cloud and how companies can make the migration process smoother and faster.

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  • 4 Change Control Pain Points in High-Stakes Manufacturing (and How to Overcome Them)

    August 28, 2019 by Connor White, Public Relations Intern, MasterControl

    Documenting change control is a crucial part of the manufacturing process. Without it, operations can become error-ridden, ineffective and at worst – they can result in costly product recalls that are damaging to consumers and companies. Learn how a digital quality management system can ensure product quality, safety and prevent delays and recalls.

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  • Top 5 Nutraceutical Trends in 2018 - Exploring Different Delivery Methods

    October 4, 2018 by Sarah Beale, Staff Writer, MasterControl

    The nutraceutical world is constantly evolving to meet consumer needs and the search for alternative delivery forms is a prime example of this. To combat pill fatigue, supplements now come in liquids, powders, lotions and sprays, but companies embracing innovation need to be aware of the challenges they face.

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  • What Biotech Startups Need to Do to Slay the Competition

    June 21, 2018 by Matthew M. Lowe, Executive Vice President of MasterControl

    Venture capitalists have pumped $2.8 billion into biotechnology startups in the first two months of this year alone. This means two things if you’re a startup. First, expect fierce competition because a huge capital pool attracts the very best in the industry. Second, this kind of investor confidence requires that you hit the ground running.

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  • Holiday Party Hosting Tip: Get an eQMS

    December 14, 2017 by David Jensen, Staff Writer, MasterControl

    It’s that time of year when we get together with family and friends and enjoy holiday festivities. Sure, all the mingling and merriment of a holiday party can be fun, but organizing an event—not so much. If you happen to be the designated planner/host of your holiday soiree, you may want to consider using an electronic quality management system (eQMS).

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  • Key Regulations & Initiatives that Modernized Compliance for Life Science Companies

    October 4, 2016 by Cindy Fazzi, Editor, MasterControl Insider

    Not too long ago, regulatory compliance meant color-coded stamps for various documents, gigantic cabinets for storing files, and truckloads of paper documents for FDA submissions. The advent of 21 CFR Part 11 signaled the movement toward automation. It’s one of 16 regulations and initiatives that helped modernize the compliance process for life science companies.

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  • Cleanroom Compliance: How to Address Common Challenges in Document Control

    May 5, 2016 Dave Hunter, Product Management Director, MasterControl

    A recent warning letter to a medical device firm shows the importance of proper documentation of cleanroom maintenance procedures and corresponding control of those documents. The FDA noted the company’s failure to establish and maintain written procedures for avoiding contamination of equipment, as well as the incongruity between some of its cleanroom procedures and records of actual practice (1).

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  • Don’t Trip over These 9 Document Control Pitfalls

    April 26, 2016 Dave Hunter, Product Management Director, MasterControl

    Document control issues are among the most commonly cited observations in FDA Form 483s and warning letters. In the medical device sector alone, document control-related issues represented 10 percent of Form 483 observations and 8 percent of warning letters in 2014(1).

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  • American Laboratories Begins Phase II of MasterControl

    November 12, 2014 MasterControl

    American Laboratories, Inc. (ALI), Omaha, NE, a manufacturer of Pancreatin, Pepsin and proteins is celebrating two years with the quality management system MasterControl and is announcing the implementation of Phase II of the system that will include Quality Events Management.  

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  • Change Control and Its Role in Continuous Quality Improvement

    April 17, 2014 by Lisa Weeks, Marketing Communications, MasterControl Inc.

    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?

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  • The EMA 2012 Guidance for Process Validation

    February 19, 2013 Peter H. Calcott, Ph.D., President, Calcott Consulting LLC

    In February 2012, the Committee for Proprietary Medicinal Products (CPMP) issued the latest version of the new EU Guidance for Process Validation (PV). At the end of October, the opportunity for consultation (comments period) closed, marking the time when the various committees review the comments for inclusion or modification of the document. Sometime in 2013, the formalized document will be issued for use. However, generally, what is presented at this stage is often close to the final versio

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