A web-based Content Management and eCompliance Solution.
Navitas pharmaREADY is specifically designed for both emerging and mid-size biopharmaceutical and medical device organizations where ease of installation, ease of use, regulatory compliance, and affordability are the primary business drivers.
Navitas pharmaREADY is a fully integrated, regulatory compliant, web-based Document Management, Training Records Management, Structured Product Labeling, and eCTD Publishing Solution Suite. pharmaREADY simplifies the complex process of creating, viewing, and managing submissions – electronic, NeeS or paper..pharmaREADY allows you to meet and maintain compliance with FDA 21 CFR Part 11 and other international standards.
pharmaREADY Product Suite Includes:
The Navitas pharmaREADY Product Suite is a tightly integrated, cost-effective combination of products tailored to the needs of meets the needs of these types of Life Sciences organizations including:
- Contract Manufacturers
- Medical Device
- Animal Health
- Clinical Research Organizations
The Navitas pharmaREADY Suite provides seamless control over the entire regulatory content management lifecycle, from document creation through regulatory submissions. Although the tools work most powerfully as an integrated suite, Individual, stand-alone pharmaREADY modules are available.
The pharmaREADY Suite is a comprehensive compliance solution.
pharmaREADY Suite is FDA 21 CFR Part 11 compliant and is also compliant with other country-specific regulatory requirements.
- DMS - Document Management System - Efficiently manage SOPs, Work Instructions, and other regulated content.
- 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 - Structured Product Labeling - Achieve immediate compliance as well as improve your entire product labeling process.
- TRMS - Training Records Management - Seamlessly manages technical training and maintenance of training records.
- PPM - Paper Publishing Module
- pharmaREADY Hosting - pharmaREADY SaaS - Minimize start-up costs with nothing to install on your site. No customer hardware or software is required.