Cambridge, MA. (November 23, 2007) – Virtify announced the availability of V3.2, the all-inclusive labeling solution that helps organizations to comply with the FDA's latest SPL (Structured Product Labeling) and PLR (Physician's Labeling Rule) standards
<virtx:SPL> is built on the open architecture Virtx platform, comprising infrastructure and business components common to all of Virtify’s products.
Version 3.2 adds the following features and benefits to the capabilities of V3.1.
- Creation of un-numbered and numbered sections in a PLR specific label template.
- Support for the break character and selected symbols in PLR Section Titles
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- Virtx SPL 3.2 also incorporated the latest schema PORP_MT050032 put forth by the FDA.
“We regard 3.2 as the premier solution for organizations to manage their SPL/PLR labels. Our solution really simplifies the process of developing and managing a label in the face of increasingly complex FDA regulations. The menu-driven, easy-to-use editing capability causes minimal changes to existing authoring processes and provides integrated capabilities to review, update, publish labels and maintain the versioning information of labels. Conversion of labels from Microsoft ® Word or other editors is straightforward and effortless. Since it is completely web-based, companies can deploy it with minimal effort with absolutely no changes to any of their client-side infrastructure" said Satish Tadikonda, President of Virtify.
Virtify’s Virtx SPL 3.2 allows companies to not only edit and convert labels but also helps them to manage and keep track of their submissions. Submissions can be easily retrieved and edited at any time without any restrictions. The inbuilt validation engine performs both Tier1 and Tier2 validation against the PORP_MT050032.xsd schema put forth by the FDA and highlights any deviance from it at the time of authoring, eliminating the need to spend effort downstream. Virtx SPL 3.2 also makes extensive use of Ajax (Asynchronous Javascript and XML) to improve the user experience.
About Virtify, Inc.
Virtify is a global company, with headquarters in Cambridge, MA and other international locations in India, Philippines and Bulgaria. We use cutting edge web-based technologies and global delivery capabilities to develop and implement innovative software products and solutions for the Life Sciences industry.
One of our strengths is our deep domain knowledge and demonstrated leadership in emerging global standards. Virtify is one of the first companies to introduce a pure web-based Structured Product Labeling (SPL) solution for managing the entire life cycle of labels. Virtify was the first to submit a SPL demo to the Food and Drug Administration (FDA) and the first company to submit a Regulated Product Submission (RPS) drug device and combination drug submission to the FDA. The first RPS Viewer was also introduced by Virtify we were the first to submit an Electronic Common Technical Documents (eCTD) drug and device submission to the FDA. In addition, we have recently been the first to submit messages in emerging standards such as eStability and ICSR. Such leadership on standards has enabled us to work closely with clients in effectively planning for emerging standards while addressing current mandates and standards for clinical and regulatory submissions.
Virtify’s clients include several pharmaceutical, and biotechnology companies, and its projects have spanned the R&D lifecycle, from discovery through commercialization.. For additional information about Virtify, please visit
www.virtify.com