Structured Product Labeling SaaS complies with SPL and PLR U.S. FDA mandates.August 20, 2009 -
Providing on-demand label conversion and compliance services for life sciences companies, Virtify Structured Product Labeling Sharesourcing solution is based on Virtx SPL, a Web-based solution that enables collaborative authoring, review, publishing, and archiving of SPL R4-compliant labels. Solution also offers 6-step SPL conversion methodology and team of conversion specialists that analyze, convert, validate, and quality check labels to comply with SPL-R4 and PLR standards.
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Original Press release
Virtify, Inc.
55 Cambridge Parkway
Cambridge, MA, 02142
USA
Virtify SPL R4 Sharesourcing Solution Provides, On-Demand Label Conversion and Compliance Services for Life Sciences Companies
Software and services solution enables rapid ROI and guarantees compliance with current FDA R4 standards
CAMBRIDGE, Mass., Aug. 10 /-- Virtify, Inc., the market leader in enterprise content compliance software solutions for life sciences companies, today announced the Virtify Structured Product Labeling (SPL) Sharesourcing solution, a new on-demand software and services offering for structured product labeling. As life sciences companies race to comply with new SPL and PLR U.S. FDA mandates, Virtify offers a complete solution that combines its flagship Virtx SPL software with a team of specialists to ensure accurate label conversion and guarantee regulatory compliance.
The new SPL R4 standard has grown in size, scope, and complexity, and for the first time includes medical device/drug kits, animal health, OTC, and biologic manufacturing segments, in addition to pharmaceuticals. SPL R4 also eliminates any remaining paper-based forms by requiring detailed ingredient codes, packaging, and establishment registration information be submitted via the FDA Electronic Submissions Gateway.
Virtify's SPL Sharesourcing solution is based on the company's advanced SPL R4 software, Virtx SPL, a web-based solution that automates compliance with current SPL and PLR standards as established by the FDA. The solution also offers an experienced team of conversion specialists and a unique 6-Step SPL conversion methodology to ensure accurate label conversion and 100% compliance. Users gain significant operational efficiencies and time savings from the SPL Sharesourcing software because it streamlines the product labeling development and regulatory submission process. They also have complete control of the labeling content creation - similar to an in-house software solution - but at a fraction of the overall cost of ownership.
"Life sciences companies are racing to comply with the aggressive new FDA standards," said Dr. Satish Tadikonda, president and founder of Virtify. "These new product labeling demands have a very real, significant financial and operational impact. We are pleased to offer a solution that makes compliance seamless and streamlined to meet all of the emerging global standards."
Virtify's SPL Sharesourcing solution offers life sciences organizations:
-- Secure, pay-as-you-go Web access to Virtify's software, services, and best practices methodology for timely and accurate SPL conversion for an affordable monthly fee
-- Unlimited use of Virtx SPL software, an advanced, Web-based solution that enables collaborative authoring, review, publishing, and archiving of SPL R4 -compliant labels
-- Easy conversion of legacy labels created in Microsoft Word
-- Automated generation of XML for label submissions in compliance with FDA/SPL and W3C global standards
-- On-demand use of Virtify's certified conversion specialists to analyze, convert, validate and quality check labels to comply with the new SPL-R4 and PLR standards.
-- Safe label transmission through Virtify's secure FDA Gateway
-- Flexible, multi-channel training and support options and Virtify's compliance guarantee
Virtx SPL is part of the Virtx Enterprise Content Compliance Software Suite, an end-to-end, Web-based solution for managing content and compliance requirements for life sciences companies. 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.
About Virtify
Virtify is the market leader in Enterprise Content Compliance software 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
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