• What Is a Document Control System?

    12 May, 2017 David Jensen, Staff Writer, MasterControl

    Being in the regulated manufacturer arena, you have heard that oft recited phrase “if it isn’t documented, it didn’t happen.” This motto shared among life sciences companies means an efficient document control system is at the core of quality management. Documents and records serve as proof that your company follows good manufacturing and document management practices required for compliance.

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  • What is a Document Management System and 8 Reasons Your Company Probably Needs One

    9 May, 2017 Marci Crane, Staff Writer, MasterControl

    A document management system is a software solution that allows for the digital management of documentation. Today most documentation managed by document management systems is business-related.

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  • Life Science Polls Reveal Lack of Automation, High Cost of Quality Stoppages

    4 May, 2017 Cindy Fazzi, Staff Writer, MasterControl

    Increased automation through digital technology platforms is one of the top business trends for 2017 (1). It’s a crucial enabler for businesses to compete successfully, according to the IT research and advisory company Gartner Inc.

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  • 10 Criteria to Aid in the Selection of Investigative Sites

    2 May, 2017 by Craig Morgan, Head of Marketing, goBalto

    Investigative sites are the heart and soul of clinical trials, essential to ensuring the efficacy and safety of pharmaceutical compounds in humans. Site selection is pivotal to the successful execution of trials, which are not only long and bureaucratic, but are also experiencing diminishing returns. Studies estimate that it costs upwards of $2B dollars to bring a new drug to market, with daily revenue losses in ranging from $1M to $8M due to delayed market entry.

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  • "We're Different!" Overcoming the Challenges of Applying Lean Principles to Knowledge Work

    27 April, 2017 by Drew Locher, President, Change Management Associates

    If you are applying lean management principles to R and D, life science, or other knowledge work processes, you’ve probably heard the "we're different” argument. It usually goes something like this, “You can’t apply lean process improvement techniques to creative work because everything we do varies."

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  • 20 Years Later, 21 CFR Part 11 is More Relevant than Ever

    24 April, 2017 Cindy Fazzi, Staff Writer, MasterControl

    If 21 CFR Part 11 and the life science industry were a married couple, they would be celebrating their platinum wedding anniversary this year. For better or for worse, in sickness and in health, it has been 20 years of compliance. It’s an important milestone to celebrate and think about.

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  • What Do Food Facility Auditors Really Want? A Practical Guide to Reducing Your Audit Stress Level

    20 April, 2017 by Bryan Armentrout , CEO, The Food Leadership Group

    Third party audits are critically important to food companies. They are the primary tool your customers use to determine if adequate food safety systems are in place. This article covers some of the strategies and tactics you should employ to maximize your chances of a successful audit.

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  • Value Adds to ISO 9001:2000 Compliance

    19 April, 2017 Sandford Liebesman

    There are three major ways 8.5.1 can be improved. Who is responsible for compliance to this requirement? Top management should have the responsibility. Also, there is no requirement for a process to accomplish continual improvement. Finally, how does one measure the effectiveness of the quality management system? Without a defined measurement of effectiveness it will be difficult to show improvement.

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  • Using Good Systems Practice to Right-Size IT Services for Emerging Biotech Firms

    19 April, 2017 Keith Parent and Christopher Port

    By Keith Parent and Christopher Port

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  • Harmonization of Quality Groups and Automated Quality Audit Systems

    19 April, 2017 Chris Ball, AMGIT

    The term harmonization has become a buzzword in the life science sector and doesn't just refer to the harmonization of international standards created by various regulatory (or voluntary) bodies but can also refer to the harmonization of company-wide cultural and political differences as well as the harmonization of varying policies and procedures introduced by company mergers and acquisitions.

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  • Ten Signs Your CEO Still Has No Idea About ISO 9001 and Lean

    19 April, 2017 Mike Micklewright, President of QualityQuest Inc.

    This article originally appeared in "Quality Digest Daily," an electronic publication from Quality Digest (www.qualitydigest.com)."

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  • Better Innovation for Product Development and Process Improvement

    19 April, 2017 Ellen Domb, Founding Editor of The TRIZ Journal and principal TRIZ consultant for the PQR Group, and Joe A. Miller, Biomedical Engineer and TRIZ consultant

    TRIZ is a problem-solving method based on logic and data, not intuition, which accelerates, broadens, and deepens a project team's ability to creatively solve difficult, pertinent problems. TRIZ provides repeatability, predictability, and reliability due to its structure and algorithmic approach. "TRIZ" is the (Russian) acronym for the "Theory of Inventive Problem Solving." G.S. Altshuller and his colleagues in the former U.S.S.R. developed the basic method between 1946 and 1985, and it has been

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  • Validation of Off-the-Shelf Software

    19 April, 2017 David S. Brown, President of David S. Brown LLC, A Consulting Firm

    "Previously published on www.MedicalDeviceSummit.com, Copyright: Innovative Publishing Company, LLC. Reprinted with permission"

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  • Pundits Forecast Pharma's Future

    18 April, 2017 MasterControl

    End of first-quarter economic reports are pouring in and the economic pundits are pondering the industry's performance in 2007 and forecasting the future of pharma in the remainder of 2008.

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  • Taming the Regulatory Beast: Role of Regulatory Trend Analysis in Successful FDA Approval

    18 April, 2017 Mukesh Kumar, PhD, RAC, Senior Director, Regulatory Affairs, Amarex Clinical Research, Germantown, MD

    The biggest risk in drug development is failure to convince the FDA that your product meets the requirements for marketing approval. By the time a company files a New Drug Application (NDA), it believes that sufficient evidence is available in support of the marketing approval, based on its understanding of the regulations and requirements. However, about 40% of the NDAs submitted to the FDA are rejected for one or another reason while more than half go through multiple cycles of review adding a

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  • SPL R4: The Latest on Electronic Regulatory Submissions

    18 April, 2017 Keith Thomas, Product Strategist and Former Director of R&D, i4i

    As of June 1st, 2009 the FDA will no longer accept Establishment Registrations or Product Listings submitted on paper for human prescription drugs, human over-the-counter drugs, or listed biologics and veterinary medicines. After that date, all such filings must be made electronically through the FDA's electronic submission gateway and encoded in XML, according to the rules set out in the HL7 Structured Product Labeling (SPL) standard and the FDA implementation guide. Medical devices are not c

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  • Submissions Processes with Templates for Microsoft Word®

    18 April, 2017 Antoinette Azevedo

    As regulatory agencies such as the U.S. Food and Drug Administration (FDA), and parallel agencies in Europe, Japan, and Canada, move toward a completely electronic submission environment, tools like templates for Microsoft Word® become increasingly essential to submissions content development processes. Templates can be essential during the preparation of electronic common technical documents, or eCTDs. The eCTD is a standard created by the International Conference on Harmonisation (ICH), a

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  • Good Clinical Practices and the Top Five GCP Violations in a Clinical Study

    18 April, 2017 Michelle Sceppa, Principal at MSceppa Consulting

    Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, biologics, devices, therapy protocols). These trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety. The regulations that provide a platform for the quality of the data are Good Clinical Practices or GCPs.

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  • Please Don't Call Them CAPAs

    18 April, 2017 Denise Robitaille, RAB-QSA Certified Lead Assessor, Author and ASQ Certified

    I've long been troubled by the ubiquitous acronym used to refer to corrective action: CAPA. My gut reaction borders on the irrational. Most of you reading this have heard of or read about or used the acronym hundreds of times. And you're probably wondering why the two syllables CA-PA should produce such an extreme reaction - especially in someone who spends a great deal of her time teaching people about both corrective action and preventive action. The short answer is simple: They're two separa

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  • Stay Ahead of the FDA: Process Mapping, Gap Analysis and SOP Review

    18 April, 2017 Kerry Potter, Founder and President of Summit Consulting, Inc.

    What happens when the FDA arrives at your manufacturing facility? Your first reaction may be panic or perhaps regret for not having solved any wayward problems the inspection team will surely now find. But it does not have to be that way. In fact, by preparing in advance and using the right tools, a firm should be able to greet the FDA by saying, "Excellent. Everyone knows what to do. Let's get right to it." That is the exact attitude companies need to have to successfully pass any inspection.

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