GxP Lifeline

 

  • FDA Device Reclassification Could Save Industry Millions

    6 October, 2010 MasterControl

    All medical device manufacturers know the implications of the Class I, II and III device categories. If a device falls in the Class I category then the probable mantra is "Full steam ahead! Piece of cake!" Perhaps this "mantra" seems exaggerated but in comparison to Class II stipulations, Class I requirements do seem relatively simple.

    Full story

  • Medical Advice from the Past Now Seems Bizarre

    MasterControl

    With medical device and pharmaceutical professionals working hard to make a positive difference, it's often interesting, and even outright hilarious, to take a look back at the medical advice/remedies of the past and to realize how far life science professionals have progressed.

    Full story

  • Few Firms Are Measuring the Cost - Did You Know?

    MasterControl

    Onboarding "new hires" or moving employees from one assignment to the next effectively and efficiently is critical to a firm's productivity and profitability. Yet, few firms measure the cost or the return on investment, and fewer still are able to eliminate such costs.

    Full story

  • Physician Payments Sunshine Act - Did You Know?

    MasterControl

    The Physician Payments Sunshine Act, sponsored by Senators Charles Grassley (Republican - Iowa) and Herb Kohl (Democrat - Wisconsin) seeks to establish a national registry of industry payments to physicians, and impose strict rules for disclosing financial relationships between drug and medical device companies and doctors.

    Full story

  • Compliance Issues with 21 CFR Part 11 Standards

    6 October, 2010 MasterControl

    The inspections are due to occur "soon" according to an announcement made by FDANews and the inspections are expected to lead to 1) additional guidance, 2) an amendment(s) to the Part 11 regulatory text, or 3) both.

    Full story

  • Growth in Clinical Research - Did You Know?

    MasterControl

    As a result, quality management software is more essential than ever for handling the data and information that comes in from clinical trials.  Fortunately, there are software solutions to accommodate literally every budget that can be easily implemented.

    Full story

  • Only One Out of Every 10,000 Medicines - Did You Know?

    MasterControl

    The product research, development and approval road is long, arduous, and costly, especially for pharmaceutical companies that are still reliant on manual processes and paper-based systems.  According to an ongoing study at Tufts (hyperlink -- http://csdd.tufts.edu/About/History.asp), the average cost of bringing a drug to market jumped from $231 million in 1991, to $802 million in 2001, to the current estimate of more than $1 billion.  After a product is successfully launched, the

    Full story

  • A Centralized Event Management Approach to CAPA Control - Did You Know?

    MasterControl

    Many medical device companies currently funnel their issues and events via a channeled process. In other words, customer complaints are reported and channeled to CAPA (if necessary) and then subsequently reported on. These complaints for example often cannot be compared to deviations since deviations are reported via another channel.

    Full story

  • Use Business Rules to Effectively Monitor Quality - Did You Know?

    MasterControl

    That you can use business rules to effectively monitor and manage critical quality events?

    Full story

  • Even Blood Without Disease Can Be Harmful - Did You Know?

    MasterControl

    Did you also know that many of the negative symptoms experienced by blood transfusion patients could be avoided with further research and joint projects sponsored by private entities, the American Association of Blood Banks and the Centers for Disease Control and Prevention?

    Full story

  • CAPA Problems Aren't Just Quality Problems - Did You Know?

    MasterControl

    Does your company have a CAPA problem? CAPA problems aren't just a quality problem but a business problem that can reduce your ability to compete and innovate. Inside the organization they become everyone's problem and they often result from an "open-looped" CAPA system.

    Full story

  • CAPA Management for Blood and Biologics - Did You Know?

    MasterControl

    Take for instance a company that has a workable CAPA management solution but is not gathering and recording all the initial issues and events that according to the FDA need to be gathered and reported.

    Full story

  • 21 CFR Part 11 Has a Retention Requirement - Did You Know?

    MasterControl

    That 21 CFR Part 11 has a retention requirement for audit trail documentation?

    Full story

  • Recent ASQ Survey Finds Companies Dissatisfied with BPOs

    7 December, 2010 MasterControl

    Many companies seek the expertise of BPOs. Business Process Outsourcers have, in many cases, shown that the BPO model can save companies significant expense. However, a recent survey conducted by ASQ shows that those company representative respondents aren't expressing the satisfaction they'd like to express in their respective BPOs.

    Full story

  • ASQ's Recent Annual Salary Survey - Did You Know?

    MasterControl

    Why is it that quality professionals have "escaped" the jaws of an unpleasant economy? There are a variety of participating factors but when all is said and done quality professionals have come out on top.

    Full story

  • MasterControl All Access Equips Blood and Biologics Organizations

    4 January, 2010 MasterControl

    MasterControl's All Access solution is designed for life science professionals who need integrated, specialized solutions that address the many challenges in their unique work environments; for those professionals who have difficulty convincing management to invest in expert tools that would save the company money; for those who find that it's not cost effective to invest in general purpose tools that you only use once in a while; and for those who require a complete quality management system (Q

    Full story

  • Seven Objective-evidence Items the FDA Will Look For

    13 September, 2011 MasterControl

    This article was originally published in the August 2011 edition of EduQuest's publication: EduQuest-ions & Answers.

    Full story

  • Did you know that in 2011 the FDA is going to be targeting Part 11 compliance more closely?

    10 September, 2010 MasterControl

    Why target adherence to Part 11 requirements?

    Full story

  • Developing a Supplier Scorecard

    23 May, 2010 Dr. George L. Harris, DBA, CPM, CPCM, President, Calyptus Group

    Organizations have attempted to measure supplier performance in a number of ways as a part of their quality management program, based on customer requests, or as part of the effort to manage supply chain risk. Supplier measurement systems have been in place since the mid 1970s with varying degrees of success, both in the product and service industries. Typically, suppliers are provided measures and targets as performance indicators, data is collected on performance and published, and the buyer w

    Full story

  • Designing a Winning CAPA System

    Larry Mager, VP of Quality and Compliance, PathWise, Inc.

    CAPA is a critical Quality System subsystem that, when executed correctly, can provide your organization with a clear payback in terms of improved compliance, effectiveness and operational efficiency.

    Full story