JMP partners with industry-leading Pharmaceutical and Life Science companies.
JMP & VelQuest: Performing Statistical Analysis in FDA Regulated Industries
The partnership between JMP and VelQuest enables pharmaceutical companies to bring safe and effective drugs to market efficiently by allowing scientists, analysts, and engineers to use all the features of JMP statistical analysis software in an FDA 21 CFR Part 11 compliant environment. The VelQuest SmartShell(TM) Technical Remediation Solution –plus– JMP® enables pharmaceutical companies to authenticate and maintain electronic records of statistical analysis. JMP software provides analytical tools used to evaluate compounds, study the effectiveness of drugs, interpret clinical trials, and perform the wide variety of analyses required to develop a safe drug.
SmartShell is available directly from VelQuest. Multi-user licenses or single user copies of JMP software are available directly from JMP.
Smart Shell Part 11 Remediation Solution
SmartShell provides a virtual shell around the JMP application. The first function of the shell is to intercept any attempt to log-in to the computer. All log-in functions will subsequently be performed by SmartShell, which will verify the eligibility of the user to use this computer and their rights to run the application as soon as they attempt to launch it. Customers may restrict rights to read-only, read-write, or read-write-modify. The shell monitors all file traffic and will, as appropriate, direct files to the secure repository where they are under full Part 11 Compliance. Once in the repository, files may not be overwritten. Instead, a new version will be created and the user will have to enter a reason code and their electronic signature. The date and time of each transaction will be recorded for an audit trail.
Files in the repository may be viewed by reviewers who have been given the appropriate eligibilities. Reviewers may add annotations; sign files as having been reviewed, attested, or approved; and lock them against further versions, signatures, or annotations. A comprehensive search capability locates files by date, file type, name of user, signatures, or other characteristics. Centralized administration of all computers, applications and user eligibilities is provided and can be managed by supervisory personnel without detailed IT knowledge.
JMP Statistical Analysis Software
JMP is the best-in-class analytic tool that can be used in every phase of drug discovery, from exploring initial compounds to producing a final product for market. Its analysis capabilities are critical for pharmaceutical companies to bring safe and effective drugs to market quickly and profitably as possible. JMP provides the general statistics and graphics, design of experiments, and quality control methods in a graphically interactive environment. Graphical interactivity in JMP means that every graph in JMP is live linked back to the data and to other graphs. Graphs and data are included in and can be expanded in the main window, simplifying information tracking and reporting, enabling all users, including those without extensive statistical training, to discover relationships in their data.
Business Case Example
Company A is developing a new anti-cancer drug which it wants to bring to market quickly. They use JMP to conduct shelf life analysis and stability prediction of the new drug to meet the consumer and FDA requirement to assure the quality of the drug taken by an individual within the shelf life is within established levels. They use JMP to explore the stability characteristics of a compound over time and extrapolate a prediction of stability of the compound. The JMP and SmartShell solution allows researchers at Company A to conduct the experiments and analyze the experimental results in a visually interactive manner, while ensuring that both the data and the analysis results are maintained in a Part 11 compliant environment.
SmartShell assures that JMP data, experiments, and results performed and accessed on any PC or any repository in the system are handled in compliance with FDA 21 CFR Part 11 requirements.
JMP analyzed shelf life stability as a function of potency decay of the compound over time. As the user selects from the right graph the value midway through the fit, marked by a value of 5, JMP automatically highlights the corresponding information in the data table on the left.
