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By BIO-IT World
Companies with low budgets and lots of computer systems that aren't compliant with 21 CFR Part 11 must prioritize which ones to fix first. One way is to estimate the data-security risk for each system and the cost of Part 11 validation, then plot that system on a matrix like the one below. Systems and processes falling in the risk range of 60 percent or higher should get high priority.  | A Central database for inventory management | 92% | | B Lab spreadsheets and databasesfor data collection | 80% | | C Systems for quality processes and standard operating procedures | 79% | | D Systems for manufacturing processes | 75% | | E Systems for liquids processes | 73% | | F Systems for company financials | 63% | | G Systems for other R&D data | 58% | | H Systems for customer relationship management | 46% | | I Systems for packaging | 25% | | J Systems being decommissioned | 22% | Source: Clarkston Consulting Back to Easing the Pain of Part 11
|  Next-Generation Technologies Revolutionizing Oncology and Diagnostics
underwritten by Definiens
This “Briefing On” collection of Bio-IT World features, commentaries and analysis, presents some of the latest thinking on high-throughput technologies that are being applied to the fields of research and drug discovery, with particular emphasis on oncology, diagnostics and imaging technologies. Download now at no charge compliments of the underwriting sponsor, Definiens. Download This Free Paper
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This Bio•IT World Briefing On “Next-Generation Sequencing,” underwritten by GenomeQuest, Inc.,
presents a selection of feature stories, interviews,commentaries, conference reports, and editorials on the emergence, opportunities, and challenges posed by high-throughput sequencing. Covered in this collection: the launch of new platforms from Applied Biosystems and Helicos; new applications of nextgen sequencing; the rise of personal genomics; and informatics solutions to vexing problem of managing the vast volumes of next-gen data. Download now
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GenoLogics
Enabling Translational Research Informatics
Learn about the challenges facing life sciences research labs to manage their translational research data:
- The trends for organizations to adopt informatics solutions for translational research.
- The unique requirements with managing complex data and workflow.
- What labs should consider when reviewing informatics solutions for translational research.
- Which life sciences research organizations are successfully adopting an informatics solution.
Download Now
More Podcasts
Assistant Editor (Science Writer)~Cambridge Healthtech Institute (CHI), Needham, MA,
Cambridge Healthtech Institute seeks an assistant editor (science writer) who is an ambitious, dependable journalist who can fulfill a range of writing and editorial duties for a series of eNewsletters covering various aspects of the biopharmaceutical industry in addition to CHI’s flagship publication, Bio-IT World magazine. This is a superb opportunity to make important contributions to the growth and success of a multimedia science publishing group, while gaining invaluable experience in multiple facets of the publishing industry. Interested candidates should submit a cover letter, including 3 writing samples (attached in Word or PDF format), salary history or requirements, and resume to kdavies@healthtech.com. Fred Hutchinson Cancer Research Center: IT Business Analyst III
The Hutchinson Center is the only National Cancer Institute-designated comprehensive cancer center in the Pacific Northwest. Through our Tumor Research Initiative, we are finding new ways to detect tumors at an early stage. We are presently seeking an experienced IT Business Analyst to assess technology needs for the Tumor Research Initiative, and to identify and design improvements to computer based systems. For more information please visit www.fhcrc.org and search for Job# AD-21465
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