CAMBRIDGE, MA - 20 Apr 2007: Virtify is pleased to announce the release of V3.1, a comprehensive solution for compiling, reviewing, and submitting Applications to Life Sciences Regulatory Agencies using the Electronic Common Technical Document standard.
is built on the open architecture Virtx platform, comprising infrastructure and business components common to all of Virtify’s products. Version 3.0 offered the following major features and benefits for SPL labels:
- Web-based rich text authoring, thus enabling the benefits of rich authoring tools without the complexities of client-side software deployment.
- Concurrent, multi-user access with Roles based access control, enabling multiple people to work on different content elements concurrently.
- Document versioning and history and the ability to retrieve any version, thus supporting the tracking of submitted and working content over time.
- Built-in Tier 1 and Tier 2 validation against the latest FDA schema, thereby avoiding downstream rework.
Version 3.1 adds comprehensive support for the PLR (Physician’s Labeling Rule) standards to the existing support for the SPL standard. All the features of 3.0 available for SPL labels are available for PLR labels. Additional PLR specific features include
- Annotation of Recent Major Changes.
- Content of Labeling Highlights Text.
- Highlights Data Elements.
- A template manager to enforce the mandatory sections and section numbering of PLR.
- Import and conversion of existing SPL labels to PLR labels.
Additional features available in the editor for all labels include support for the creation and management of Document Footnotes and Table Column Alignment.
As is the case with SPL labels, all features are available via an intuitive user interface which hides the underlying technical complexities of XML and the standards from content authors.
About Virtify
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 http://www.virtify.com.