Navigation Links
Virtify, Inc. Delivers Industry's First Enterprise Content Compliance Software Suite for Life Sciences Companies
Date:6/22/2009

First and only Web-based solution for managing compliance and regulated content throughout the product lifecycle reduces costs, risk, and time-to-market

SAN DIEGO, June 22 /PRNewswire/ -- Drug Information Association 45th Annual Meeting -- Virtify, Inc., the market leader in enterprise content compliance solutions for life sciences companies, today announced the upcoming release of its Virtx integrated software suite, an end-to-end, Web-based solution for managing the complex content and compliance requirements in the highly regulated pharmaceutical, biotechnology, medical device, animal health and food sciences industries. Unlike traditional content management solutions or individual point products, the Virtx software suite provides a secure, collaborative online environment for managing regulated content throughout the entire life sciences product continuum. The Virtx suite is also pre-configured to comply with different global standards and regulatory mandates such as Clinical Trial Disclosure, Electronic Common Technical Document (eCTD), Structured Product Labeling (SPL) and other electronic submissions standards. At the same time, the Virtx software suite can accommodate future mandates and initiatives by global regulatory bodies.

"The cost of bringing new drugs to market ranges from $800 million to $1.2 billion and it's estimated that roughly 26% comes from the content requirements associated with regulatory compliance," said Alan Louie, Ph.D., research director for IDC Health Industry Insights. "Faced with the daunting challenge of upgrading fragmented, paper-based-processes that make timely postings and filings nearly impossible, life science companies are relying increasingly on new technologies to comply with the changing regulatory environment. The impact of non-compliance is significant, and includes costly product delays, regulatory fines, and lost market opportunities."

"The ability to dynamically author, manage, access and re-use accurate content is critical to bringing consistency to validation processes, which aids in introducing new drugs to market in a more timely manner," said George Skillin, senior director at Wyeth, a Virtify customer. "Virtify's approach to enterprise content compliance makes this possible by automating and streamlining the complex content exchange requirements across the entire product continuum, from scale-up through to full operations. By enabling content structure and re-use across the many tasks required for engineering validation and other activities, Virtify enables companies like Wyeth to streamline these efforts, reduce costs and increase operating performance through the product life cycle."

The Industry's First Collaborative, Web-Based Solution for Enterprise Content Compliance

The Virtx Enterprise Content Compliance Software Suite automates a variety of legacy, paper-based processes and is pre-configured to comply with different global standards and regulatory mandates. The suite's workflow design enables collaborative content authoring, reviewing, archiving, and re-use - virtually eliminating inconsistencies and redundancies enterprise-wide. Virtx tailors upstream functions, such as content authoring and reviewing to meet electronic requirements and standards, while automating downstream functions such as assembly, publishing, delivery and archiving.

Key capabilities include:

  • Out-of-the-box compliance with existing global electronic submission standards by ICH and HL7, among others;
  • Best practice, compliant-ready configurations designed to automate compliance with current and evolving global standards;
  • Flexibility to license separately (SaaS or perpetual), or in combination as part of an integrated enterprise content compliance solution;
  • User friendly Web 2.0 interface; familiar Microsoft/desktop-like conventions promote ease-of-use for non-technical users in business, clinical, regulatory, and manufacturing functions;
  • Shared content repository, which separates content from structure enabling Virtify's unique "create once, publish many" approach to managing regulated content. Changes made once, can be leveraged across all applications and publishing outputs; and
  • Common metadata repository enabling standard nomenclature across all products improving data accuracy and flow, and overall interoperability across the entire Virtx ECC software suite.

"Life sciences companies are increasingly challenged as global health and regulatory authorities enact strict regulations and fines surrounding new and emerging mandates and e-standards," said Dr. Satish Tadikonda, president and founder of Virtify. "Effectively managing these processes directly impacts a life sciences company's ability to compete. Virtify's flexible and robust solution is built specifically to streamline compliance processes, enabling enormous time and cost efficiencies, while bringing higher quality products to market faster and more efficiently."

The Virtx Enterprise Content Compliance Software Suite

All Virtx products are web-based and can be licensed separately or in combination as part of an integrated enterprise content compliance solution. The software is also designed to leverage a company's existing technology infrastructure including standard security systems, databases and legacy document management systems. The complete software suite includes:

Regulatory eCompliance Products

  • Virtx SPL - Labeling application that complies with US FDA SPL R4 and PLR formats
  • Virtx eCTD - eCTD builder, viewer and publisher supporting ICH as well as regional standards
  • Virtx CTDS - Clinical Trial Disclosure System for global compliance automation and management
  • Upcoming Standards Support:
    • Virtx PIM - Labeling supporting EU EMEA Product Information Management standards
    • Virtx RPS - Product supporting HL7 (Health Level 7) Regulated Product Submission standards
    • Virtx eStability - Product supporting HL7 Electronic Drug Stability standards

Enterprise eCompliance Products

  • Virtx SCM - Workflow enabled structured content management for collaborative document authoring, reviewing, assembly, publishing, and delivery
  • Virtx CDS - Product for managing a company's Core Data Sheet including change notifications and response tracking
  • Virtx RIS - Information Exchange Platform combining process, methodology and a modular, componentized platform for organizational-specific R&D and commercialization information
  • Virtx RMA - Web-based Resource Management and tracking
  • Virtx ST - Submissions Tracking and planning
  • Virtx IDM - Investigator clinical trials management
  • Virtx PRS - Patient Registry/clinical trial management

Virtify is a featured solution provider at the DIA Annual Meeting Booth 403.

About Virtify

Virtify is the market leader in Enterprise Content Compliance solutions for life sciences. Organizations rely on Virtify solutions to reduce time-to-market, risk, and costs by managing and automating the complex regulatory compliance and content exchange requirements throughout the product life cycle. Virtify's easy-to-use Virtx software suite is the industry's only solution to provide a secure, collaborative web-based environment for managing regulated content throughout the entire continuum - from pre-clinical through product registration to commercialization. The company plays a leadership role in the development of global regulatory standards and is an active participant in a variety of standards committees. Virtify's software products combined with comprehensive professional services and deep domain expertise enhance quality and compliance for some of the world's leading life sciences companies. Located on the Web at www.virtify.com


'/>"/>
SOURCE Virtify, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. CompareNetworks Media Group Delivers CME/CE Through Acuity Medical Education
2. Nikon Instruments New NIS-Elements C Delivers Comprehensive Confocal and Widefield Imaging Capabilities in Single Unifying Software Platform
3. Millennium Over-Delivers on 2007 Goals and Financial Guidance
4. NIOXIN(R) Delivers the Future to Scalp and Hair Care, Introduces the First Genetic Test to Determine the Likelihood of Hair Loss
5. Core Informatics Delivers Enterprise Core LIMS Installation to BioRelix Pharmaceuticals
6. New Turbomolecular Pumping System From Varian, Inc. Delivers Portable, Dry, Ultra-high Vacuum.
7. Shire Delivers Strong Quarter: Driven by $243m of New Product Sales (+164% YOY Growth). Revenue Guidance Upgrade.
8. InVitrias Cellastim Delivers Superior Results in Mammalian Cell Culture
9. Plexon Inc Delivers 500th "Harvey Box" : 25 Years of Neural Data Acquisition and Analysis Leads to 500th System Sale
10. Shires New Product Portfolio Delivers Strong Quarterly Performance
11. RainDance Technologies Delivers RDT 1000, Sequence Enrichment Solution to JCVI
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... (PRWEB) , ... October 11, 2017 , ... ... pathology, announced today it will be hosting a Webinar titled, “Pathology is going ... Pathology Associates , on digital pathology adoption best practices and how Proscia improves ...
(Date:10/11/2017)... Tbilisi, Georgia (PRWEB) , ... October 11, 2017 , ... ... disaster, taking the lives of over 5.5 million people each year. Especially those living ... the greenovative startup Treepex - based in one of the most pollution-affected countries globally ...
(Date:10/10/2017)... , ... October 10, 2017 , ... San Diego-based team ... its corporate rebranding initiative announced today. The bold new look is part of ... the company moves into a significant growth period. , It will also expand its ...
(Date:10/10/2017)... ... October 10, 2017 , ... Dr. Bob Harman, founder and CEO of ... Club. The event entitled “Stem Cells and Their Regenerative Powers,” was ... Dr. Harman, DVM, MPVM was joined by two human doctors: Peter B. Hanson, M.D., ...
Breaking Biology Technology:
(Date:4/5/2017)... , April 5, 2017 Today HYPR ... that the server component of the HYPR platform is ... providing the end-to-end security architecture that empowers biometric authentication ... HYPR has already secured over 15 million users across ... manufacturers of connected home product suites and physical access ...
(Date:3/30/2017)...  On April 6-7, 2017, Sequencing.com will host the ... hackathon at Microsoft,s headquarters in Redmond, Washington ... developing health and wellness apps that provide a unique, ... is the first hackathon for personal genomics and ... in the genomics, tech and health industries are sending ...
(Date:3/28/2017)... March 28, 2017 The report ... (Camera, Monitors, Servers, Storage Devices), Software (Video Analytics, VMS), ... - Global Forecast to 2022", published by MarketsandMarkets, the ... and is projected to reach USD 75.64 Billion by ... 2022. The base year considered for the study is ...
Breaking Biology News(10 mins):