Enables regulatory affairs professionals to comply with the EMA’s Labeling requirements
Virtify has unveiled new software product PIM Enterprise, part of the Enterprise Content Compliance (ECC) Software Suite, which is designed to help companies stay compliant with the new EU labeling standard and enable the creation of PIM submissions in a collaborative, "best-practices" environment.
The company said that the PIM standard is being implemented to enable the efficient exchange and evaluation of product information for obtaining marketing authorisation in Europe.
The prime goal is to reduce the repetition of content across multiple countries and documents through a single, centralised XML submission.
Virtify said that its new software offering is designed to enable customers to comply with the PIM standard for submitting product label information in an efficient, consistent and predictable manner.
It allows users to operate at the PIM element and PIM fragment level and allows authors and reviewers to "parallel-process" different sections of the PIM submission or submissions.
Virtify president and CEO Satish Tadikonda said that they have engineered PIM exclusively for life sciences companies, providing the necessary features and functions that will greatly simplify the submission of XML-based product labeling information.
In addition, PIM is designed to support changes to the PIM standard without costly system redesign.
This is made possible through Virtify’s XML Rules Injection 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.