Compliance Management Software addresses EU labeling standard.
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Press Release Summary:
Helping companies remain compliant with EU labeling standard, Virtify PIM Enterprise enables creation of PIM submissions in collaborative, best-practices environment. Structured content approach lets users operate at PIM element and PIM fragment level, promoting content control and flexibility while also permitting parallel processing of different PIM submission sections. Web-based product has deployment and implementation cycle independent of third party infrastructures or solutions.
Original Press Release:
Virtify Simplifies PIM Labeling with New Software Release
- New Virtify PIM Enterprise Enables Regulatory Affairs Professionals to Comply with the EMA's Labeling Requirements - in 24 Languages and Standard XML Format
Virtify, Inc. (http://www.virtify.com) today announced the upcoming release of its new software product Virtify PIM Enterprise, part of the Virtify Enterprise Content Compliance (ECC) Software Suite. Virtify PIM is designed to help companies stay compliant with the new EU labeling standard, and is the first and only off-the-shelf, Web-based product that enables the fast and efficient creation of PIM submissions in a collaborative, "best-practices" environment.
The PIM standard is being implemented to enable the efficient exchange and evaluation of product information for obtaining marketing authorization in Europe. A key goal is to reduce the repetition of content across multiple countries and documents through a single, centralized XML submission.
Moreover, electronic authoring and publishing for PIM XML must integrate with existing translation processes and software. Successfully managing PIM complexity is not a trivial undertaking, especially for companies using manual processes and traditional document management systems.
Virtify PIM Enterprise is an advanced software solution designed to enable customers to comply with the PIM standard for submitting product label information in an efficient, consistent and predictable manner. Virtify PIM's unique structured content approach allows users to operate at the PIM element and PIM fragment level-the same content levels specified by the PIM standard.
This capability provides users with unprecedented content control and flexibility, allowing authors and reviewers to "parallel-process" different sections of the PIM submission or submissions, resulting in greater speed and efficiency. Other software solutions designed to operate at the document level cannot provide these benefits. In addition, the software has a rapid deployment and implementation cycle and is not dependent on any third party infrastructure or solution. Deploying Virtify PIM software will enhance productivity and reduce risks, while providing significant and demonstrable ROI in a short period of time.
The PIM standard is currently in pilot. It is expected to move into production in 2011 for new approvals using the centralized procedure. A full migration of legacy product information will be required in the future.
"Once PIM is implemented, companies are expected to realize substantial cost and time savings in managing their European submissions while increasing submission quality. However, complying with PIM using traditional document centric processes and systems will be a challenge," said Satish Tadikonda, president and CEO of Virtify. "We've engineered Virtify PIM exclusively for life sciences companies, providing the necessary features and functions that will greatly simplify the submission of XML-based product labeling information."
Virtify PIM is built upon Virtify's structured content management engine which enables enterprise scalability and performance in a lightweight Web application. Key capabilities include:
- Comprehensive PIM Lifecycle Management with integrated workflow for rapid status and centralized management of PIM submissions including content creation, review, approval, and translations, as well as bi-directional communication and comments from EMA
- Role-based, granular access control at the PIM document, PIM element, PIM fragment, and language level. This unique structured content approach allows for the easy tagging and reuse of common content elements across documents
- Automated XML generation with no programming knowledge required by business users
- Integrated Translation Management through standard web services for translation tracking and status reporting through the Virtify PIM dashboard
In addition, Virtify PIM is designed to support changes to the PIM standard without costly system redesign. This is made possible through Virtify's unique XML Rules Injection(TM) technology which separates the "rules engine" from the core PIM application so that changes to rules can be easily uploaded without redesigning the entire software system. This approach provides organizations with a great deal of flexibility and control over the timing and scheduling of rules updates, significantly reduces software maintenance and validation costs, and provides rapid compliance with evolving business rules.
Virtify is currently exhibiting at the 2nd Successful eCTD Lifecycle Management Conference in Prague, Czech Republic. Virtify PIM Enterprise will be available to customers in October 2010.
About Virtify
Virtify is the market leader in Enterprise Content Compliance software solutions for life sciences. Organizations rely on Virtify solutions to reduce costs, mitigate risk, and accelerate time-to-market 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 product continuum - from pre-clinical through product registration to commercialization. Virtify's product suite includes software products for Global Labeling, Clinical Trial Disclosure, and Structured Content Management. 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
Beth Monaghan of InkHouse (for Virtify), +1-781-791-4552 ext. 564, virtifypr@inkhouse.net
