• Automating Training Control Processes to Comply with FDA and ISO Requirements

    Brian Curran, SVP, Stategic Marketing & Product Management, MasterControl, Inc.

    FDA regulatory requirements and ISO quality standards mandate companies to execute and document employee training. (21 CFR 211.25 and 820.25) These requirements ensure employees understand how to perform their duties within company and industry guidelines. Well-managed training programs minimize the risk of non-compliance and improve product quality. This article identifies the basis for the requirement and examines the associated challenges for meeting the requirement and the shortcomings that

    Full story
  • Automating Document Control Processes to Comply with FDA and ISO Requirements

    13 April, 2017 Jason Clegg, Marketing Director, MasterControl, Inc.

    The purpose of document control systems is to ensure that manufacturers build products that are safe and reliable. ISO and FDA Current Good Manufacturing Practices (CGMPs) presume that both the process and documentation that directs company processes follows pre-approved methods and that any change to these methods is restricted to authorized personnel and tracked for future review. All FDA-regulated and ISO-certified companies are mandated to have a document change control system.

    Full story
  • How Auditing Supports Supply Chain Management

    6 October, 2010 Dennis R. Arter, FASQ, CQA

    There are four parts of supply-chain management:

    Full story
  • Annex 11: The EU's New Expectations for Regulated Computerized Systems

    10 April, 2012 Martin Browning, President and Co-Founder, EduQuest

    Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

    Full story
  • Annex 11 and 21 CFR Part 11: Comparisons for International Compliance

    31 January, 2012 Orlando Lopez, Independent Consultant

    The two essential resources available to regulated life-science professionals regarding the validation of computer systems are: the Food and Drug Administration's (FDA) rule on Electronic Records/Signatures (21 CFR Part 11 aka Part 11) and the European Medicine Agency's (EMEA) Guidelines to Good Manufacturing Practice (GMPs) - Annex 11, Computerized Systems (aka EU Annex 11).

    Full story
  • Six Costly Mistakes that Start-Up CEOs Should Avoid

    28 November, 2012 Greg Davis, Founder & CEO, MedCelerate

    Representing one-third of the global medical device market, the European Union provides a significant opportunity for start-up medical device companies. But, it can also present costly challenges for the unprepared. Following are a half-dozen cautions drawn from real-world experience that could help you avoid the most common commercial pitfalls.

    Full story
  • Finding Ways to Cope with New Medical Device Tax

    19 February, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    Medical device companies started paying a 2.3 percent excise tax this past January as part of the Affordable Care Act, also known as "Obamacare." The industry has opposed the tax, which is being assessed on total revenues, not profits. The Obama administration has said the excise tax will be offset by an increased number of insured people receiving treatments; it's something that remains to be seen.

    Full story
  • The US Medical Device Industry: Future Growth Sectors May be Different Than You Think

    10 August, 2013 Michelle Bonn, Owner & President, Expedient Trade LLC

    The medical industry is one of the most stable industries with respect to growth.  However, we are seeing interesting global trends that will impact the sustainability of medical device manufacturers and suppliers across the United States.

    Full story
  • Employing Audits for Improved Supplier Performance

    3 April, 2012 Bob Mehta, GMP ISO Expert Services

    Note: The views expressed in this article are those of the author and do not necessarily represent those of his employer, GxP Lifeline, its editor or MasterControl Inc.

    Full story
  • eMDR Conversion and Implementation - Part II

    27 March, 2012 Eugene Reilly, FDA's Center for Devices and Radiological Health

    Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

    Full story
  • eMDR Conversion and Implementation - Part I

    29 February, 2012 Eugene Reilly, FDA's Center for Devices and Radiological Health

    Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

    Full story
  • How Life Science Companies Can Leverage Mobile Technology

    10 April, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    Mobile technology has come a long way. Smartphones and tablets are getting better, smaller, and less expensive. It is no wonder that almost everyone has one.

    Full story
  • Quality and Risk Management in Clinical Studies

    17 July, 2012 Patricia Santos-Serrao, Senior Product Manager, Life Sciences, MasterControl, Inc.

    With all that goes into a clinical trial, from documentation and procedures, to a variety of study support staff, managing risk may often be overlooked or merely addressed in a reactive way. However, in order to increase success in clinical trials, an organization must have an efficient risk management plan and be proactive and not simply reactive. In order to obtain a complete understanding of risk in a clinical trial, a risk assessment must be taken from various perspectives. Also, risk man

    Full story
  • Clinical Research: Common Challenges in Sponsor-CRO Relationship

    28 November, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    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.

    Full story
  • How Social Media Is Advancing Healthcare

    24 April, 2013 Laurie Meehan, Internal Project Manager, Polaris Compliance Consultants, Inc.

    Facebook’s IPO last year received a lot of media attention. While the news was mostly financial, the huge sums of money being discussed were not the only numbers associated with the social networking site that can give pause. Facebook now boasts more than a staggering 1 billion users. To put that in perspective, that’if Facebook were a country, it would be the 3rd largest in the world. And while Facebook is the biggest, it’s not the only social networking giant. Depending what source you co

    Full story
  • The European Qualified Person - What's It All About?

    17 April, 2012 Wolfgang Schmitt, Director Operations, CONCEPT HEIDELBERG GmbH

    Note: The views expressed in this article are those of the author and do not necessarily represent those of the employer, GxP Lifeline, its editor or MasterControl Inc.

    Full story
  • Business Benefits of Archiving

    30 March, 2013 Jim Cook, CEO, Arkivum

    The word “archive” is springing up all over the world of IT and data management. Why now, and what are the implications to an organization working within the highly regulated world of a GxP environment? This article sets out some of the key business drivers around long-term data storage, and offers some lifelines to IT professionals drowning under a deluge of data.

    Full story
  • One Year Later: The FSMA and the Food and Beverage Industry

    18 April, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    A year has passed since the Food Safety Modernization Act (FSMA) was signed into law. Some of the changes envisioned under the FSMA are already in place, such as the FDA's new mandatory food-recall authority and the authority to detain food products that the agency has reason to believe are adulterated or misbranded.

    Full story
  • FDA Sets New Priorities for Foods and Veterinary Medicine

    17 July, 2012 News Desk, Food Safety News

    Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

    Full story
  • The U.S. Biosimilar Pathway Nearly Three Years Later

    11 December, 2012 Erika Lietzan and Laura Sim, Covington & Burling LLP

    Note: The views expressed in this article are those of the authors and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

    Full story