Regulatory Articles

81. A Comparison Of Process Validation Standards 6/6/2014

    U.S. life science firms are currently subject to two different process validation standards: the Global Harmonization Task Force’s Process Validation Guidance and FDA’s Process Validation: General Principles and Practices. These standards have considerable overlap, both officially and practically, across the drug and medical device industries. Previously, all FDA divisions followed a single guidance document, but that document has long since been superseded by new regulations and advances in validation science. This article examines the differences and similarities between the two guidance documents and concludes that any firm manufacturing product whose predicate regulations require process validation (drugs, devices, Active Pharmaceutical Ingredients, biologics, or human-based tissues) should incorporate the philosophies and directives of both to meet Agency expectations and to assure the highest quality of their products. By Jeff Boatman, senior subject matter expert, medical devices and quality systems, QPharma Inc.

82. Don't Use Last Century's QMS Tools For This Century's Medical Devices 5/14/2014

    It goes without saying that a well organized and auditable quality management system (QMS) is job number-one for medical device manufacturers. However, a surprising number of organizations are still using Microsoft Office — specifically Word and Excel, both of which were invented in the 1980s — to manage their quality and design systems. By Steve Chalgren, Arena Solutions

83. A 15-Minute Guide To Clinical Trial Document Management And The eTMF 5/30/2013

    At the Drug Industry Association’s (DIA) annual meeting held in June 2012, the TMF Reference Model Working Group released TMF reference model 2.0, which included significant updates from the group’s 2010, 1.0 release.

84. Medical Device Companies Turning To New Breed Of Supply Chain Partner 4/19/2013

    Medical Device companies are well aware of the strategic and operational impact of tougher reimbursement policies and the soon to be implemented medical device tax.

85. Improving Quality Processes For Medical Device Development And Manufacturing 3/21/2013

    Organizations that consistently develop and launch new products efficiently in an environment of increasing regulatory scrutiny, successfully manage regulatory risk. By Mike Kuehne, ACSYS, Inc.

86. Medical Device Quality Systems Demystified: Why Companies Need Best-Of-Breed ERP, PLM And EQMS 4/19/2011
    Intense global pressures, such as more stringent regulatory scrutiny, tax increases and reimbursement challenges are causing stalled top-line growth for medical device organizations and prompting them to find ways to increase operational efficiencies. By Sparta Systems, Inc.
87. White Paper: Medical Device Quality Systems Demystified: Why Companies Need Best-Of-Breed ERP, PLM And EQMS 4/19/2011
    Intense global pressures, such as more stringent regulatory scrutiny, tax increases, and reimbursement challenges are causing stalled top-line growth for medical device organizations and prompting them to find ways to increase operational efficiencies. By Sparta Systems, Inc.
88. White Paper: Reducing The Documentation Burden In FDA Design Control Process By Using A Web-Based System 6/17/2008
    The design and development of medical devices is a challenging endeavor in and of itself. Add to that the regulatory environment in which medical device developers must operate, and the task can seem insurmountable. This white paper will explore ways of reducing the documentation burden and accelerating overall project timelines by taking advantage of the technology offered by Web-based document management systems.
89. Article: Getting More Out Of Your Quality Management System 6/7/2006
    A centralized quality management system (QMS) provides organizations with a single centralized tool to handle all quality management-related aspects
90. Article: Conquering Compliance Management 6/7/2006
    It’s no secret that FDA regulated industries are motivated to find better ways to comply with ever-increasing government regulations and formative industry standards