Virtify Simplifies PIM Labeling With New Software Release
By Virtify Inc., PRNEMonday, September 13, 2010
New Virtify PIM Enterprise Enables Regulatory Affairs Professionals to Comply with the EMA's Labeling Requirements - in 24 Languages and Standard XML Format
PRAGUE, September 14, 2010 - Virtify, Inc. (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 at inkhouse.net
Tags: Czech republic, Prague, September 14, Virtify Inc., Western Europe