Showing items tagged as Pharma

  • Leverage TOQ for a Faster, Cost-Effective Software Validation

    10 April, 2014 by Richard Dirkson, Senior Validation Services Consultant, MasterControl Inc.

    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.

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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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  • 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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  • 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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  • 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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  • 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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  • Quality’s Role in Drug Approvals

    12 June, 2014 by Theresa Allio, Ph.D.

    In a recent review, I summarized the underlying reasons contributing to delayed market entry for 51 product applications submitted to CDER between 2009 and 2012.1 Reasons cited in the complete response letters issued for these applications covered a number of areas, including safety, efficacy, regulatory, labeling and quality related issues. Quality- related issues were one of the most prominent reasons for delay of market entry with deficiencies being cited in 20/51 (39%) of applications. GMP inspection failures and data deficiencies contributed equally to the quality citations. The prominence of quality-related issues in the delay of product approvals emphasizes the importance of robust quality programs in drug development. Understanding what elements have posed as hurdles in past development programs will help a sponsor avoid these pitfalls in the future.

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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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  • Are You Ensuring Supplier Quality?

    8 July, 2014 Christine Park, Quality Architech, Christine Park & Associates

    "Everyone cares about quality. Just ask them. However, unless someone actively measures quality performance, you must question the commitment to improvement."

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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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  • Regulatory Records Primer Part 2: Decoding the Requirements for Pharmaceutical Manufacturers

    26 August, 2014 Les Schnoll, Quality Docs, LLC

    In Part 1 of the Regulatory Records Primer (Decoding the Requirements for Medical Device Manufacturers), I discussed the general requirements and thought processes undertaken by the FDA with respect to regulatory records.  While the drug side has not yet “evolved” to using a quality systems approach to the regulatory requirements, the same basic process holds true.  Following is a discussion on the regulatory records required to be maintained by manufacturers of finished drug products.

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  • What You Don't Know About the Drug Supply Chain Security Act (DSCSA) Implementation Plan

    28 August, 2014 Peter Knauer, Senior QCC Consultant, MasterControl Inc. and Moj Eram, Regulatory Consultant

    This article discusses the implementation aspects of the new Drug Supply Chain Security Act (DSCSA), which was signed into law (Title II of Public Law 113-54) by President Obama on November, 27, 2013. The Act intends to build a comprehensive, standard electronic and interoperable system to identify and trace prescription drugs in the US.

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  • FDA Issues New Q&A On Data Integrity

    2 September, 2014 Jamie Colgin, Colgin Consulting, Inc.

    Recently FDA published a new set of seven questions and answers. Three questions cover data integrity and e-signatures. While the Q&A target GMP, there are lessons to be learned for all of us:

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  • Choosing the Right Drug Name: How to Increase Your Chances for Approval

    4 September, 2014 Susan M. Proulx, President, Med-ERRS

    The pharmaceutical industry is all too familiar with how exceedingly challenging it can be to achieve a viable trademark that is accepted by the health authorities, especially if obtaining a global mark is the end goal. Over the past few years, health authorities in several countries have been developing their proprietary name guidances. In the last six months alone, both Health Canada and the FDA released guidances pertaining to proprietary name development – Health Canada’s proprietary name guidance was finalized and FDA released its first-ever initial draft guidance on the topic of name selection and development. Industry is now curious to learn how these guidances will affect their current trademark development and selection process and their trademark’s chance of approval.

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  • Communicating Priorities to Your Employees

    16 September, 2014 Curt Porritt, SVP, Marketing, MasterControl Inc.

    Needless to say, if managers don’t understand corporate priorities, they can’t communicate them to employees. Entire departments may pursue the wrong priorities, causing stra­tegic corporate plans to become less effective. I’ve seen a lot of this. Likewise, if managers understand the priorities, but have not communicated them well to their departments, the results can be the same. And if employees are left to themselves to decide what the priorities are, not only are the efforts of your teams unlikely to match corporate goals, they probably won’t even match each other. You will likely have employees working in different directions, even within the same departments or even on the same projects.

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  • Why Do Corrective Actions Fail?

    23 September, 2014 Ed Grounds, President Integrated Solution Providers Software, Inc.

    Each year, the most popular learning course we provide is targeted at developing the skills necessary for our customers’ associates to implement their corrective action programs effectively and efficiently. Throughout the years, we have been asked the same question hundreds of times, “What are the most common reasons corrective actions fail?” Usually this question is asked during the corrective action learning session by a management team member hoping that we will deliver the message to the other team members that they are failing. Normally, we turn the question back around to the group and ask them why they think their corrective action program fails. The most common answers we hear are: limited time, resources, training, or not knowing which tools to use.

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  • The 3 Biggest Project Management Problems in the Regulated Environment

    2 October, 2014 Paul Sanderson Lead, Solutions Consultants Group, MasterControl Inc.

    Effective project management helps your company save time and money by keeping projects on time and on budget. It optimizes your resources by assigning the right people with the right skills for every project. In a regulated environment, you need all of these, plus one more crucial consideration: compliance.

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  • Evaluating the Effectiveness of a Corporate Compliance Program: A Holistic Approach

    21 October, 2014 Brian A. Dahl Dahl, Compliance Consulting

    Now more than ever, pharmaceutical companies must not only have an effective corporate compliance program in place, but senior management and boards of directors at these companies must ensure that they evaluate the effectiveness of those programs. The best reason to evaluate the effectiveness of your compliance program is so that you know whether or not the program is managing the particular risks facing your company. If you are responsible for protecting your company from risk, shouldn’t you want to know that your compliance program is working?

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  • From Good to Great – The One Skill Great CRAs Possess

    23 October, 2014 Holly Deiaco-Smith, MS

    Don’t get me wrong, these skills are important and they are point of entry for a good CRA. These skills are expected as a minimum set of skills to be hired for the job of CRA but they are not the skills that differentiate a great CRA. 

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  • MasterControl Says “Go Live” to Localized Websites

    6 November, 2014 Jason Clegg, Director of Marketing, MasterControl

    At its core, website translation is a process that allows everyone across the globe to access the same opportunities and/or products in their own languages. This is especially important to companies like MasterControl that are expanding in to international markets.

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