• Project Management in a Learning Organization: Thriving on Change While Delivering Results

    14 April, 2017 MasterControl

    Life science industries are no different than any other money-making organization:  their bottom line is profit.  The difference in their profitability, though, often lies in the way they conduct their business.Peter Senge of the Massachusetts Institute of Technology advanced the theory of the learning organization.  He said learning organizations are “…organizations where people continually expand their capacity to create the results they truly desire, where n

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  • Meet a New Alligator, it's the QA/IT Disconnect

    14 April, 2017 Keith Parent

    By Keith Parent

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  • Practical Solutions to Audit Challenges Faced by Life Science Companies - GxP Lifeline

    MasterControl

    How to Solve the Top Five Quality Audit Challenges

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  • The Cost of Quality: a Study on Life Sciences

    14 April, 2017 MasterControl

    The Cost of Quality: a Study on Life SciencesThe Cost of Quality: a Study on Life Sciences webinar presents findings from the published report, The Cost of Quality: a Study on Life Sciences, a benchmark study by the AberdeenGroup. The report compares the quality standards and tactics of life science companies from the pharmaceutical, biotechnology, blood/biologics and medical device industries with those of Best-in-Class manufacturers. According to the report, "Aberdeen surveyed 169 [&helli

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  • Study: High-Performing Manufacturers Enforce Enterprise-Wide Quality Procedures as Top Business Strategy

    14 April, 2017 MasterControl

    A recent survey of 176 manufacturers throughout the world shows that more than half of best-in-class companies enforce enterprise-wide quality procedures as a top business strategy.These high-performing manufacturers take a more disciplined approach toward enforcing quality procedures, and are farther along in closing the quality loop than poorer performing companies, according to a benchmark study by the Aberdeen Group, a leading research group for the technology-driven value chain.The s

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  • Compliance Competitive Advantage: Technology-Based Approach for Quality Management

    MasterControl

    Study: Regulated Manufacturers Using Technology-Based Approach to Compliance Gain Competitive Advantage

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  • Gems on REMS

    17 April, 2017 Peter Pitts

    I recently chaired the "Risk Management and Drug Safety Summit" (co-sponsored by the Center for Medicine in the Public Interest, FDA News, and United BioSource Corporation). It was a content-rich experience.

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  • Advantages to Risk-based Validation

    17 April, 2017 David Ade

    Decrease Computer System Validation Time and Costs by Implementing a Risk-based Approach

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  • Benefits of a Risk-Based Approach

    17 April, 2017 David Ade

    By David Ade

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  • Six Ways to Optimize Your Quality Management System to Ensure FDA and ISO Compliance

    17 April, 2017 MasterControl

    MasterControl software can optimize your Quality Management System to help ensure FDA and ISO compliance.

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  • How Soon Can You Get Me That Six-Year-Old Data?

    17 April, 2017 Daniel R. Matlis

    By Daniel R. Matlis

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  • Stagnation vs. Innovation: FDA's Critical Path Initiative

    17 April, 2017 MasterControl

    Americans born in the 1940s marvel at the advances made in modern medicine since their birth. Vaccines, penicillin, antibiotics, CAT scans, the unraveling of the human genome and cancer drugs have led the march of medical progress into the 21st century. And with so many achievements in medicine during the last 70 years, it is not surprising that Americans expect this trend to continue. But such expectations may be unrealistic. The high costs of drug and medical device development are hamperi

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  • How Life Science Companies Can Avoid Pitfalls in System Evaluation

    17 April, 2017 Jim Murrin

    The FDA is decidedly moving toward an electronic environment. Late last year, the agency solicited comments on its continuing effort to transform all regulatory submissions from paper to electronic and its plan to create an electronic platform that would facilitate the exchange of drug safety and other important clinical research information.If you work in the life science industry, there is probably no way to avoid automation in the long run. Not only is FDA policy pointing toward that di

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  • Pharmaceutical Industry’s Transition from Paper-Based to Electronic Processes

    17 April, 2017 MasterControl

    Pharmaceutical Industry’s Transition from Paper-Based to Electronic Processes.

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  • Validating Electronic Spreadsheets or Automated Forms

    17 April, 2017 Louis Rutledge, Manager of Validation Services and Solutions, MasterControl

    Since the release of 21 CFR Part 11 in 1997, the validation and verification of electronic records has been at the forefront of the Information Technology (IT), Quality Assurance (QA) and Regulatory departments of the medical device and pharmaceutical industries. From simple record control through electronic signature approval routing and automated records processing, the validation of these functions can offer a substantial challenge to the average IT or QA personnel member not familiar with c

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  • Creating Value Solutions Through Assessment and Risk Reduction

    17 April, 2017 Chris Ward and Thomas Menighan, RPH, MBA, SynTegra Solutions

    Auditing is a more formalized assessment process. Whether we are assessing vendors like software developers whose products are used in the automated processes for manufacturing of pharmaceuticals or medical devices or the less technologically driven processes like pharmaceutical distribution channels for supply chain integrity; the process of inspection can help create useful data to support development of technology for specific uses. These audits also stimulate the utilization of technology

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  • Making the Move to Collaborative Work - Feature - GxP Lifeline

    Kate Wrightson Merlino, Senior Technical Editor in the Technical Services Division, nSight

    What is a collaborative work environment? Almost all work has collaborative elements: we work with co-workers, managers, and subordinates in teams, committees, and departments. We use many environments and tools to share information and ideas. While working together is not a new concept, technological advances and shifts in workplace culture have changed the way we work.

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  • Good and Bad Responses to 483s

    Cathy L. Burgess, Esq., Crowell & Moring, LLP

    Preparing a response to a Form FDA 483 can be a time-consuming and stressful process. It diverts resources from other activities and, if not managed properly, the process can be overwhelming. If a 483 response is well written, factually correct and complete, it will establish that the firm has taken or is in the process of taking appropriate corrective and preventive action. This can allay FDA concerns about the firm's compliance, and reflect positively on the organization. If the response i

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  • Good Clinical Practice: From Review to Application

    18 October, 2011 Rebecca York, Clinical Research Associate, IMARC Research

    As clinical research professionals, we often hear phrases like, "It's in the regs!" Or, "It's GCP!" At times, it may seem as though by classifying our actions as "GCP," we wave a magic wand that ensures regulatory compliance. But what is GCP, and what does it mean to be GCP compliant? In order to take "good" to "great," it is important understand the conceptual framework that supports good clinical practice and be able to apply that understanding in daily research practice.

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