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GxP Lifeline
  • Partnering with Quality Professionals Worldwide

    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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    The Value of Performing a Good ValidationIn Transfusion Medicine

    The blood establishment bears the responsibility for the regulatory compliance of the automated/computerized systems used. Full validation of the computerized system is required for systems critical to product and quality (information management, storage, tools for operational decision-making, and control). The Quality Risk Management approach to validation advocated by GAMP 5 and ICH Q9, a life cycle approach within the QMS, and the use of risk assessments to define the validation strategy for

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

    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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    Demystifying FDA/CDRH Appeals Process

    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.

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  • Changing Supplier Controls Requirements

    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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    Collaboration is More Than Just a Buzzword in Regulated Environments

    Each year, there seems to be a buzzword that pervades the business community. This year, I recall hearing the word “collaboration” more than ever. For most organizations, the word is synonymous with “participate.”

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    Establishing a Master Harms List: Streamlining Risk Management

    Risk management is a sore point for a lot of start-ups during their product development programs. FMEAs, FTAs, ISO 14971- the sheer number of acronyms alone is staggering! I excitedly introduce you to another one – the MHL, or Master Harms List. Aligning product failures identified in risk management activities with their corresponding clinical harms sometimes becomes very labor intensive. In attempting to ensure that all relevant harms associated with a product’s component failures are captured, the engineer is presented with an expansive list of possibilities. Consumer risk is a permanent priority: thorough risk analysis is forever coupled with patient and physician safety.

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    Grid Analysis for Simplified Supplier Selection

    The selection of a new supplier can be an arduous process, and the importance of the decision is inarguable.  Changing suppliers when continuous improvement recommendations fail to succeed most surely will result in high switching costs.  Ultimately, the decision is worth careful evaluation, which makes a grid analysis a useful and easy tool to use.

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    FDA Inspections: Be Prepared to Ensure Quality and Compliance

    You have just been informed by your boss that the FDA is coming to conduct an inspection of a clinical study recently completed at your facility. Does this raise your anxiety level and that of your staff to near panic levels? A FDA inspection can bring on images in your mind of a large room, bright lights and grueling questions. Probably no other agency of our government can evoke a more frightening scenario, except for maybe an IRS audit. However, with proper planning and preparation, a FDA inspection does not have to be a nightmare experience.

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    Elements of Effective Quality Agreements

    Many GxP professionals are already familiar with the expectation of FDA and the requirement in the EU to have quality agreements with third parties and suppliers. Throughout this article, I will define what a quality agreement is, when one is needed, the 24 basics that factor into this critical document, and some things to avoid when drafting one. Finally, I will discuss alternate means of communicating quality expectations when a supplier will not agree to enter into a full quality agreement.

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    New Draft Guidance on Quality Agreements: No Passing the Buck on CGMPs

    Last month, FDA released a draft guidance document entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The guidance addresses relationships between the entities that introduce a drug into interstate commerce (the “Owner”) and third parties that perform some or all of the manufacturing operations for the product (the “Contracted Facilities”). The guidance describes how Owners and Contracted Facilities can use Quality Agreements to define responsibilities associated with

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    Using History to Predict the Future of Quality

    Predicting the future is fool’s play---think Edsel, Nostradamus, even Chicken Little. But if you or your organization is wrestling with what direction to take your quality programs and your entire organization, perhaps a brief look at history will aid in developing your future strategies and culture of quality.

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    Creating, Staffing and Managing an Inspection War Room

    When I served in the military there was a term used that is still pretty familiar today: "sound general quarters!" When this order was issued, everyone instinctively stopped what they were doing and manned whatever station was theirs during that time. All commands during general quarters came from the war room behind the bridge of the vessel.

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    Five CAPA Compliance Tips

    Having been intimately involved in how the U.S. Food and Drug Administration (""FDA"") inspects current Good Manufacturing Practice (""cGMP"") requirements for nearly two decades, I find myself repeating certain things to companies. Most often, the issues I repeat relate to Corrective and Preventive Action (""CAPA"") systems. CAPA systems are a focal point in FDA inspections precisely because they are the process that manufacturers follow in case something goes wrong. In the same way that a person'

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    New Report Highlights Need to Reduce R&D Cost

    Most pharmaceutical and biotechnology companies already feel the pressure to reduce their R&D costs. A recent report showing a decline in the ROI for R&D among some of the world's biggest companies is not going to ease the pressure.

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    What SOPs Do You Need As A Dietary Supplement Distributor?

    If you look at the cGMP regulations for dietary supplements, you'll notice that only one subpart includes the words "holding" or "distributing" in its title. With only 10 or so individual requirements, the aptly-named Subpart M, "Holding and Distributing," is shorter than most. If you're thinking this means there's a much lighter regulatory burden placed on companies that simply hold or distribute dietary supplements than on companies that manufacture them, you'd be right. At the same time, y

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  • Developing a QMS: Should You Buy or Build?

    When it comes to a quality management system, should you buy or build? Many regulated companies face this dilemma. Perhaps these companies are small startups without a QMS, or maybe they are established but they want to improve their existing systems.

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    Clinical Research: Common Challenges in Sponsor-CRO Relationship

    Outsourcing thrives in good times and bad. Life science companies rely on contract research organizations to complement in-house work in times of growth and expansion, but they also rely on CROs to reduce costs in times of financial downturn.

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  • Can You Use Automated Testing Tools as an FDA-Regulated Company?

    Can you use automated testing tools as an FDA-regulated company?

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    Surviving the Back Room During an FDA Inspection

    During one of my early inspection experiences with the FDA, I found myself working with a team that felt it didn't need a backroom setup to review documents prior to bringing them to the investigator. Naively, I agreed to let the team move forward with the inspection. As the observer, I watched as things spiraled out of control.

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