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SAN DIEGO, Calif. (DIA 45th Annual Meeting)-June 22, 2009-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:
o Out-of-the-box compliance with existing global electronic submission standards by ICH and HL7, among others;
o Best practice, compliant-ready configurations designed to automate compliance with current and evolving global standards;
o Flexibility to license separately (SaaS or perpetual), or in combination as part of an integrated enterprise content compliance solution;
o 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;
o 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;
o 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:
o Virtx PIM – Labeling supporting EU EMEA Product Information Management standards
o Virtx RPS – Product supporting HL7 (Health Level 7) Regulated Product Submission standards
o 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 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