JMP and 21CFR Part 11 Remediation Solutions
Friday, January 14
There are no JMP seminars scheduled at this time.
Upcoming Tradeshows & Conferences
ASQ Six Sigma Conference
Six Sigma in Chemicals & Pharmaceuticals
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This publication may be freely redistributed if copied in its entirety. Portions of this newsletter may be reprinted with permission.
JMP® and VelQuest software enable pharmaceutical companies to bring safe and effective drugs to market efficiently. Together, VelQuest SmartShell™ Technical Remediation Solution and JMP let pharmaceutical companies authenticate and maintain electronic records of statistical analysis to evaluate compounds, study a drug's effectiveness, interpret clinical trials, and perform the wide variety of analyses required to develop a safe drug.Attend our webinar with a CFR Part 11 expert. Learn about risk management for the pharmaceutical industry. Learn how to make dramatic improvements in productivity, analytic capabilities, and cycle time. Discover how SmartShell, SmartLab, SmartBatch and JMP software can help the pharmaceutical industry in a FDA 21 CFR Part 11 compliant environment. READ MORE
Streamlining the Switch from Minitab to JMP
Customers who switch from Minitab to JMP are faced with the challenge of converting their Minitab files to JMP files. Previously, this process involved saving to an intermediary file format, such as text, and then importing the file into JMP. This is a time-consuming process, particularly when you have large numbers of files.
dfPower DBMS/Copy from DataFlux (www.dataflux.com), a SAS Company, automatically converts Minitab 13 files to JMP 5 files. It performs seamless translation of all data and platform-related conversion issues. And with its batch conversion function, you can quickly and safely convert hundreds of files in just minutes. Customers who wish to convert files from Minitab to JMP now have a streamlined method for accomplishing the task.For more information, please visit the DataFlux website. READ MORE
"Common Sense" Practices
and Creative Alternatives to Address 21 CFR Part 11
This article, by Ken Rapp and Ian Edmonds, originally appeared in the October 2004 issue of Pharmaceutical Formulation & Quality magazine and is reprinted with permission.
Three Significant principles are at the heart of the 21 CFR Part 11 Legislation and the new guidance associated with this law. First, companies must perform a risk assessment to determine the status of computer systems and their “risk of importance” to the manufacturing and delivery to consumers and public safety according to the Guidance surrounding FDA's cGMPs for the 21st Century initiative.
Second, PC-based systems should not be capable of inadvertently overwriting files without user alerts, intervention, maintaining the original file, documenting date and time, documenting the reason for changes and authorization.Third, FDA is actively trying to encourage the industry to use technology to improve the efficiency of operations and is committed to making the Part 11 rules sensible and helpful rather than presenting an obstruction to progress. READ MORE
White Paper: "The JMP Advantage"
JMP® software's unique visualization paradigm provides the best environment for designing experiments, analyzing and exploring data, and uncovering trends that might otherwise go unnoticed. JMP can be customized and tailored to fit the varied needs and levels of practitioners in your organization, and its graphical interactivity enables everyone to make a contribution to the productivity gains promised by Six Sigma. JMP is ideally suited for those needing a desk-top statistics package that is suited for all users, including every level of Six Sigma practitioners from Master Black Belts on down.This paper highlights the distinctive aspects of JMP, its user interface, Six Sigma tools and advanced statistical modeling capability. READ MORE
JMP User Conference set for June 2005
The second annual JMP User Conference, June 7-8, 2005, at SAS World Headquarters in Cary, NC, will feature special sessions for novice JMP users as well as for company executives, among other innovative surprises. Add your name to the interest list that already boasts an international audience.Statistical training specialist Mark Bailey; certified JMP training specialist Marissa Langford, and JMP marketing representative Paula Miscavage have been named conference co-chairs.
JMP Tip: Executing Several Actions
To invoke several commands simultaneously, hold down Alt while right-clicking the red triangle or the blue disclosure triangle. This displays a window with check boxes for commands and options so you can select multiple actions. READ MORE
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