PharmaReady™ Suite

PharmaReady™ is a web-based electronic Document Management and e-Submissions Solution suite specifically designed for both emerging and large Life Sciences organizations. The PharmaReady™ solution suite is designed specifically for management of SOPs, Work Instructions, Training Records, eCTD Submission Documents, Trial Master Files and eCTD Submission templates. PharmaReady™ is in full compliance with global regulatory requirements.

Product Highlights

• Document Management Module - A DMS to efficiently manage SOPs, Work Instructions, and other documents within regulated business areas
• eCTD Module - Electronic Common Technical Document-Easily submit in the ICH and regionally recommended XML format while supporting submissions lifecycle management, role-based authoring and intuitive electronic content assembly processes
• Paper Publishing Module - a complete web based application, facilitating paper submission via an array of simple to use screens, the final output of which is a portable document format (PDF) file that can be printed and submitted to the appropriate regulatory body
• Submission templates – Full set of CTD submission document templates and authoring toolbar.
• SPL Module - Structured Product Labeling for FDA compliant content of labeling, product listings, establishment registrations and labeler code assignments
• Training Records Module - A TRMS to seamlessly manage technical training and maintenance of training record
• TMF - Complete Trial Master File solutions, including templates that are ICH and GCP compliant
• PharmaReady™ Hosting - PharmaReady™ On-Demand rental model solution for the various modules. Minimize start-up costs with nothing to install at your site. No customer hardware or software is required

Why TAKE's product

• PharmaReady™ Suite is a comprehensive compliance solution that helps you to define and manage all your quality / regulatory document and submission needs
• PharmaReady™ Suite is FDA 21 CFR Part 11 compliant and is also compliant with other country-specific regulatory frameworks
• PharmaReady™ Suite provides seamless visibility into the entire regulatory document management lifecycle, from document creation all the way to regulatory submissions