Pharmaready Version 4.1 - FDA- Compliant Document Management System Designed For The Regulated Life Sciences Industry

Main Category: IT / Internet / E-mail
Article Date: 04 Nov 2008 - 3:00 PDT

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TAKE Solutions' Life Sciences division announced today the release of PharmaReady Version 4.1 which offers powerful new enhancements to its fully integrated, web-based suite of products.

In 2003, PharmaReady was first introduced as an FDA- compliant Document Management System in conjunction with Microsoft Corporation at the annual DIA Meeting in Washington, D.C. "From the beginning, PharmaReady was specifically designed for the regulated life sciences industry. Five years and scores of satisfied customers later, our focus still remains the same", states Robert MacDougall, Executive Vice President, TAKE Solutions. Now, PharmaReady has been successfully deployed throughout the US, Canada, Europe, Australia and Asia. Today, world-class PharmaReady may be best known for its fully integrated document management and submissions publishing, ease-of-use, and affordability.

The PharmaReady team continually seeks input from its customers to further the effectiveness and easy-of-use of the solution suite. This is most evident in the latest PharmaReady 4.1 release, where it is apparent that we have listened to these needs and suggestions from our customers. Please reference the list of 4.1 new features and enhancements below:

PharmaReady V4.1 Highlights:

Document Management System (DMS)
-Virtual Document Workflow and Interface Enhancements
-Enhanced Office 2007 Integration and Support
-Document Owner Functionality and Role

Electronic Submissions (eCTD)
-eCTD Enhanced Support for Canadian STF Submissions
-Increased eCTD Support for STF Sub-Structures
-Enhanced Acrobat Support
-eCTD Submission Compile Time Decrease and Enhancements
-Support for Updated eCTD Guidance from FDA

Training Records Management System (TRMS)
-Option to Add TRMS Events Directly to Outlook Calendar
-Enhanced Action Item Processing
Structured Product Labeling (SPL)
-Workflow Notifications can be turned off / on
-Updated Scripts to Better Support FDA Guidelines

This newest version of PharmaReady is currently being implemented by several well known companies worldwide. These latest implementations include: INC Research, a global Clinical Research Organization based in Raleigh, NC; Trace Life Sciences, a leading supplier of medical isotopes based in Denton, TX; Dermal Laboratories, a dermatological research, development and marketing company based in the UK; and AbCRO, a Clinical Research Organization based in Sofia, Bulgaria.

About PharmaReady™

PharmaReady is a fully integrated web-based product and services solution suite including Document Management, Training Records Management, Structured Product Labeling and Submission Services. PharmaReady is specifically designed for life science organizations where ease of installation, ease of use, Part 11 compliance, and affordability are the primary business drivers. The PharmaReady solution suite is designed for management of SOPs, work instructions, training records, submission documents and all other documents within business areas regulated by the FDA. PharmaReady is a fully 21 CFR Part 11 compliant solution based on Microsoft Windows technology.

http://www.PharmaReady.com

About TAKE Solutions

TAKE Solutions is a leading international business technology company with products backed by a strong domain expertise in Life Sciences and Supply Chain Management - to provide cost-effective, comprehensive solutions for businesses. The vision of the company is to drive industry best practices through our proprietary, in-depth product know-how and solutions that enable business efficiencies for our clients. Since its inception in 2000, TAKE has been serving marquee clients in the Life Sciences and SCM arena. TAKE Solutions conducts business today in 12 countries with more than 300 customers.

Headquartered in Chennai, TAKE primarily drives its SCM Domain Excellence Centre and Global Delivery Centre from India. Company has strong presence in the USA with Life Sciences Domain Excellence centres located in Princeton, New Jersey.

TAKE Solutions is assessed at Level 5 of the Capability Maturity Model Integration (CMMI) & Level 3 of the People Capability Maturity Model , Software Engineering Institute, Carnegie Mellon University, USA. TAKE Solutions is a Microsoft Gold Certified Partner, a Charter Member of the Microsoft BioIT Alliance, and is a Registered CDISC Solution Provider.

TAKE Solutions' Life Sciences