i4i's New A4L Enterprise 4.1. Provides Hosted Alternative with Enhanced Functionality for the Authoring, Management and Submission of Global Labels

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i4i Inc., a world leader in the design and development of collaborative XML content solutions for the life sciences industry, announces its release of A4L Enterprise Edition 4.1. The A4L solution is a robust, life-cycle tool for the authoring, management, publishing and submission of drug product documents. A4L addresses the complexity of ever-changing regulatory processes via a web-services based user-friendly environment. Adhering to the standards of multiple regulatory requirements in the US (SPL) and Europe (PIM, MRP, DCP), life sciences manufacturers are tasked with authoring, managing and auditing label submissions that meet specific jurisdictional requirements but also allow for global regulatory stakeholders to author, review and audit within geographically dispersed areas - often asynchronously, and in numerous languages (24 in EU). A4L is 21 CFR Part 11 compliant with full audit trail; version management and content re-use capabilities.

i4i Inc., a world leader in the design and development of collaborative XML content solutions for the life sciences industry, announces its release of A4L Enterprise Edition 4.1. The A4L solution is a robust, life-cycle tool for the authoring, management, publishing and submission of drug product documents. A4L addresses the complexity of ever-changing regulatory processes via a web-services based user-friendly environment.

Adhering to the standards of multiple regulatory requirements in the US (SPL) and Europe (PIM, MRP, DCP), life sciences manufacturers are tasked with authoring, managing and auditing label submissions that meet specific jurisdictional requirements but also allow for global regulatory stakeholders to author, review and audit within geographically dispersed areas - often asynchronously, and in numerous languages (24 in EU). A4L is 21 CFR Part 11 compliant with full audit trail; version management and content re-use capabilities.

A4L Enterprise Edition is a web based environment that is built on a group of management and XML services that support content development and collaboration across many business areas of a pharmaceutical manufacturer. Designed to meet regulatory requirements and business processes that range from a single, authoritative view of label content to the exchange of content between multiple authorities, A4L can be delivered to suite the needs of users across locations. Based on web-services A4L can be deployed as an installed or hosted solution providing flexibility and scalability in deploying users across locations and time zones.

A4L’s ALiCE Online user interface provides work areas and dashboards in one intuitive view. Dashboards to manage Variants, Translations, Collaboration and Relations can be configured according to user authority and needs, enabling business specific processes and key interaction for specific authoring, publishing and validation functions.

Collaborations dashboard provides a graphical view that highlights the parallel review and authoring process managing the flow of work on documents from users across versions and locations while the Variants dashboards creates branches that outline the parallel authoring process flagging information that can be reused across documents. A Relations dashboard provides a detailed graphical representation of all documents supporting the main creation of a submission. Translations can be effectively managed whether translations are processed through a translations vendor, translations memory or internally.

The ALiCE Folder Structure highlights department specific resources where the user can add applications as they require. Central Window shows resources that are currently being interacted with, while panes to the upper right display metadata about those current resources. Messaging area in the bottom right allows users to create, review and manage messaging, creating a very collaborative environment.

“This new version of A4L is a platform that encourages growth and interaction, enabling drug manufacturers to expand their authoring, managing and auditing of labels across departments and jurisdictions, through very flexible services. Market demand has dictated the need for a blend of solutions and A4L meets that requirement. Web services have enabled this platform to be rolled out to global users based on regulatory time and place requirements. The authoring, management, auditing and submission of content can be done seamlessly and effectively across the globe.” said Michel Vulpe, Founder and CTO i4i Inc.

A4L’s web-based platform enables collaboration between local and geographically-distributed content authors and reviewers. Content can be re-used across documents, further driving efficiencies and improving document quality and compliance - by ensuring all parties are using correct and pre-approved content.

Based in Toronto, Canada, Infrastructures for Information Inc. (http://www.i4i.com) is a world leader in the design and development of XML-based collaborative content solutions and technologies. The company has a proven record of accomplishment and innovation, having authored international standards and patented its technology. Through the use of i4i's comprehensive suite of products, life science companies can author, verify, submit and manage product labeling requirements across the globe. i4i has successfully developed and deployed collaborative content solutions for customers in life sciences, governments and other industries around the world.

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Karen Heater
i4i
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