RE: Part 11 compliance

From: "Terri J. Fisher" tjfisher@clinapps.com Subject: RE: [NMusers] Part 11 compliance Date: Mon, 8 Aug 2005 09:30:09 -0700 Hi Phil, Without a doubt, the most advanced choice for this is a product called SmartPK developed by Clinapps, Inc. This web-based software brings 21 CFR Part 11 compliant, electronic recordkeeping to your NONMEM environment. All input and output files are stored electronically in read-only format, including the data and control stream files used to produce the results. Full audit trail capability captures a record of each transaction in a relational database. In addition to being able to create user accounts and assign roles to control project/study level access, Smart PK v2.0 allows you to move your NONMEM analysis from the desktop to a clustered server environment, allowing you to execute multiple runs simultaneously, accelerating your modeling and analysis process. This is similar to GRID computing, but at a fraction of the cost with an advanced user interface that is specific to NONMEM. Here are just a few of the other advanced features that Smart PK v2.0 provides: - Batch load thousands of NONMEM runs at a time - Non-parametric bootstrapping - View INTER files while NONMEM runs are in progress - Email notification of completion - Easy to use, web-based interface - Diagnostic plots and parameter comparisons at your fingertips You can go to the Clinapps web site at http://www.clinapps.com and download a data sheet for Smart PK v2.0 that outlines this popular new software or request a demonstration by calling (805) 494-1777, ext. 3. Kind Regards, Terri Fisher Pharmaceutical Projects Director Clinapps, Inc. (805) 494-1777 tjfisher@clinapps.com _______________________________________________________