Virtify EVMPD software and services provide flexible, cost effective options for meeting July EU deadline for new EVMPD data
Cambridge, MA– December 15, 2011– Virtify, Inc., announced today its new, innovative Virtify EVMPD software, part of its suite of structured content management based solutions to assist life science companies in meeting regulatory requirements. Virtify EVMPD enables organizations to address the EU’s July 2012 deadline for the submission of additional data to the EudraVigilance Medicinal Product Dictionary (EVMPD). With the Virtify approach, resources invested to meet the mandate result in lasting benefits to companies beyond simply achieving EVMPD compliance.
Virtify EVMPD software helps customers collect, validate, and manage the relevant data and provides the capability to submit the data electronically to the EMA. This includes the ability to efficiently provide updates on product data when product information is changed. By applying the Virtify structured content approach, all data gathered is optimized for re-use across the organization. In addition, the company’s experienced services organization offers services to assist companies to identify, find, collect, and report the required data.
Virtify EVMPD is a hosted solution that can operate as a standalone product or as a module to the Virtify Global Labeling product suite. Key features include the ability to import data from spreadsheets and Word documents, a web front-end for creating and editing content, and the ability to pull in product information by uploading and attaching existing product documents in Word or PDF format. The solution also provides the ability to store/update companywide vocabularies and substances along with EMA published controlled terminology, a robust capability for submission validation and response processing, and a configurable workflow. When Virtify EVMPD is used in conjunction with the Virtify European Labeling module, Product Information documents are already in the system and can be pulled in simply by referencing them. Such customers enjoy the ability to meet mandates such as EVMPD more easily by leveraging data currently organized and aggregated as part of normal label creation and maintenance activities performed in the Labeling product.
As part of a total solution approach, Virtify’s service organization provides services that can be utilized independent of or in combination with Virtify EVMPD. Specifically offered are gap analysis services, data organization services, and submission and publishing services.
“Clients appreciate our flexible, total solution approach,” said Satish Tadikonda, CEO and founder of Virtify. “Many companies have started gathering the necessary data, but are interested in supplementing their in-house efforts with an experienced team. Others need both the expertise and manpower to meet the deadline. Almost all, even those who were expecting to rely solely on their existing Regulation Information Management systems, are attracted to our Virtify EVMPD because it enables them to get a substantial return on investment for the time and resources spent on this mandate.” Dr. Tadikonda continued, “Our expertise and technology for structured content management and content re-use takes what is a significant challenge for many companies and provides an opportunity to move in a direction they have already had in their plans.”
Virtify is the market leader in Structured Content Management 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 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. www.virtify.com