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Dear Friends, If you're not familiar with it, you probably should be. The Risk Based Approach is a reality check for most systems in a life science company. On April 5th, LSIT conducted a workshop on using the risk based approach to address each chapter of the Good Informatics Practices (GIP) Guidance Document. Barbara Nollau, a world renowned presenter on the subject, GAMP board member and LSIT Technology Advisory Board (TAB) member provided some key tips and insights to applying the Risk Based Approach. Protecting patients and the company's assets are the top priority. She showed how, using a risk based approach which includes multi-functional perspectives, it is possible to achieve the optimal outcome from an IT system. Building on that theme, Angelo Esposito has contributed his thoughts on the matter in his article below, "The Case for Using Risk-Based Assessments." So what are the lessons learned from Angelo and Barbara? By building a risk-assessment team that includes finance/accounting, marketing, regulatory affairs, manufacturing and, most important, IT, you will gain insights, and perhaps even a few "a-ha" moments, that will help address risk management and mitigation thoroughly and completely with the appropriate level of rigor to assure compliance. To be cost and resource effective, it is important to have a team member at the senior leadership level who can provide guidance for the company's risk tolerance, culture, and strategic business alignment. As a whole, a multi-functional team should deliver a different kind of Risk-Reward result in not just quality systems, but in the quantifiable measures of costs, uncovering of hidden costs, and even ROI that are important in managing risk. - Anette Briefly:
The Case for Using Risk-Based Assessmentsby Angelo Esposito Regardless of industry orientation, geographical location, or number of years doing business, organizations around the globe realize that appraising critical functions and responsibilities against a risk-based yardstick is both effective and necessary. Owners and shareholders alike are demanding that management take an all-encompassing and holistic approach in identifying, categorizing and mitigating risks to the core business. In certain highly regulated industries, (most notably bio-medicine and pharmacology), applying a risk-based methodology is nearly mandatory. Industry observers predict that it is only a matter of time before legislation is passed mandating compulsory risk-based assessments. But whether driven by regulatory fiat or simply by good management practice, an effective risk-based program is rapidly becoming the foundation upon which many companies choose to build their superstructure. Read the full article here Angelo Esposito is the president of ATP Consulting and helps companies understand and implement customized risk-based assessments for their particular line of business.
The Flow of Data from Bench to Bedside: Finally Enabled by Electronic Submission.by Dirk Karsten Beth As with other industries, information is the substrate of Life Sciences, yet the Life Sciences have been slower to adopt information technology than other industries. Aircraft manufactures have been "virtually" test flying aircraft for decades now. The financial industry has been working with electronic regulatory submissions for about the same amount of time. But we are at a new age of life sciences, a period where discovery through bedside will be enhanced through the use of information technology. Read the full article here Dirk Karsten Beth is President of Mission3, Inc. , an LSIT member who provides enterprise software solutions for Life Sciences companies including project-based document management, global electronic submission management, enterprise project planning, publishing, and xml content authoring. The solutions are largely web-based and are focused on integration using modern web-services. Mission3 is currently integrating their solutions with Oracle's E-business Suite and Oracle's Life Sciences Stack to enable cohesive flow of an enterprises data. For more information visit www.mission3.com.
Kudos Corner: A special thank you to Cedric Armstrong.
Cedric is a gentleman with quite the reputation in Southern California, where he is known as one of a small handful of experts in Life Science Security. We are indebted to his depth and breadth of knowledge and the content he is providing to the Security Chapter. Coming soon!! Mission Possible: Security Guidance like you have never seen before. Cedric, thank you for all of your contributions and commitment to LSIT.
A quick congratulations...
Congratulations are in order to LSIT contributor Genevieve Hanson of Lpath, Inc. Lpath, a leader in therapeutic agents against bioactive lipids, recently closed the first tranche of a $16.8M equity financing deal. Lpath's CEO, Scott Pancoast, is quoted in the press release as saying "This funding represents an important milestone for Lpath and is a clear affirmation of the value of our accomplishments and potential." Genevieve, all of us at LSIT congratulate you and we look forward to hearing about more successes at Lpath soon.
And briefly...
Approximately $60 million is expected to be available under a new Advanced Technology Program (ATP) competition to support high-risk industrial R&D projects. The funding will be available for specific research projects by individual companies or industry-led joint ventures to accelerate the development of innovative technologies. For more information, visit the competition site |
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Pfizer, Inc. What is GIP?
The vehicle by which LSIT will imbue trust in the bioresearch enterprise will be the application of trusted IT guidelines through Good Informatics Practices (GIP). Read about how LSIT intends to develop GIP here Contact Us
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