PharmaReadyTM Complete Suite
A web-based electronic Document Management and eSubmission Solution
PharmaReady is a web-based electronic Document Management and eSubmission Solution suite specifically designed for both emerging and large Life Science organizations where ease of installation, ease of use, regulatory compliance, and affordability are the primary business drivers. The PharmaReady solution suite is designed specifically for management of SOPs, Work Instructions, Training Records, eCTD Submission Documents, and all other electronic documents. PharmaReady is in full compliance with global regulatory requirements.
PharmaReady Complete Suite Comprises
PharmaReady Complete Suite is a tightly integrated, cost-effective document and submission management product tailored to the needs of the following small, medium and large life science companies, including start-up ventures:
- Medical Device Manufacturers
- Generic Drug Manufacturers
- Animal Health Care
- Clinical Research Organization
PharmaReady Suite provides seamless visibility into the entire regulatory document management lifecycle, from document creation all the way to regulatory submissions. PharmaReady Suite is also available à la carte with individual products.
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.
- DMS - Document Management System - Efficiently manage SOPs, Work Instructions, and other documents within regulated business areas.
- eCTD - Electronic Common Technical Document-Easily submit in the FDA-recommend XML format while supporting submissions lifecycle management, role-based authoring and intuitive electronic content assembly processes.
- SPL-PLR - Structured Product Labeling - Achieve immediate compliance as well as improve your entire product labeling process.
- TRMS - Training Records Management - Seamlessly manage technical training and maintenance of training records.
- PharmaReady Hosting - PharmaReady On-Demand - Minimize start-up costs with nothing to install on your site. No customer hardware or software is required.
- eTMF - Electronic Trial Master File - Fits perfectly well with DIA’s Reference Model for the TMF (Version 1.0, June 4, 2010)