Document management suite gets training records tool with eCTD capabilities slated for V4.0

 (Princeton, NJ) stepped up the power of its PharmaReady document management suite by adding a training records management system in the software's version 3.0 release. The management software, which utilizes Microsoft Windows technology, is fully FDA 21 CFR Part 11, cGMP, and HIPAA compliant. It is designed specifically for SOPs, work instructions, training records, submission documents, and all other documents within FDA-regulated business areas.  

Features present in the latest release include Active Directory authentication, email reminders, expanded reader assignment features, and advanced PDF publishing capabilities.  

TAKE Solutions also announced launch plans for Version 4.0 to include fully structured product labeling and eCTD modules. Then, clinical documents stored in DMS today will automatically migrate into the eCTD module for compilation, publishing, and regulatory submission. 