A complete solution that eliminates business disruption, reduces cost, and guarantees integration with the FDA ELIPs system.

The benefits of Structured Product Labeling are dramatic—both in terms of immediate impact on the approval process and long-term enabling of more effective health systems. At the same time, SPL is a very pervasive change that will affect authoring, storage, submission, and publishing of label content. Organizations that have wrestled with technology change in the past are justifiably concerned.

SPL is an imperative and the chances are that most organizations will meet the FDA timeline for submission. The approaches taken will vary widely, and from a strategic standpoint it is imperative that success not be measured solely on whether labels were delivered on-time and in the proper SPL format.

Ultimately, three things will measure how succesful each organization was in their efforts to implement SPL: business continuity, readiness for the future, and total cost-of-ownership.

Business disruption directly affects the bottom-line and success with SPL requires maintaining business continuity. To do this, the people involved in the labeling and submission process must be able to perform their job functions at least as efficiently as they do today, and the overall business process must not be negatively impacted.

The In.vision SPL Accelerator ensures business continuity because:

• Authors work in Microsoft Word, most often using your organization’s existing template design.

• Internal users review labels as normal, with no additional learning curve or overhead.

• The production and submission process is not disrupted or delayed by outsourcing.

• The SPL Accelerator prepares labels for integration with your current eCTD submission resources.

• SPL labels may be stored in current document management resources with minimal or no change to the system.

• Labels submitted to the FDA are guaranteed to integrate with the FDA’s ELIPs review process for SPL. [1]

The long-term vision for interoperable healthcare systems will require ongoing revision to the SPL standard and the implementation of many similar standards across other functional areas of the organization. The most successful approach will provide a foundation for reducing the effort required to implement each subsequent change.

The In.vision SPL Accelerator mitigates risk and provides readiness for the future since:

• Future versions of SPL can be implemented with little or no change to the authoring experience.

• The accelerator provides a strategic path for long-term implementation of XML technology while delivering immediate results.

• The organization owns the infrastructure and knowledge that will simplify the adoption of future XML requirements for labels, clinical trials, and other documents.

A rigorous technology mandate should not create the opportunity for unjustified pricing practices. Success also means clearly defined value propositions for hard-costs, soft-costs, and on-going maintenance of an SPL solution.

The In.vision SPL Accelerator provides the lowest true cost-of-ownership because the Accelerator:

• Supports current investment in desktop and server software.

• Leverages investment as the organization moves from one phase of functionality to the next.

• Eliminates throw-away investment in conversion, implementation, and outsourcing services.

• Provides flexibility to deliver future SPL requirements with in-house resources or the integrator of choice.

The components of the In.vision SPL Accelerator provide a complete solution that fits your enterprise strategy for submission and publishing. All components of the In.vision SPL Accelerator are designed to integrate with a variety of existing resources for submission of eCTD and publishing of labels. Included configuration tools and API interfaces ensure easy development of the capability to integrate with home-built or lesser-known eCTD and publishing packages.

The Xpress Author SPL Accelerator provides a natural authoring experience in Microsoft Word while ensuring that documents comply with the SPL Schema Version 2a, and associated FDA requirements expressed in Implementation Guide Version 2a dated March 2005. This Accelerator includes:

• Xpress Author pre-configured to SPL requirements.

• An out of the box template for immediate authoring of SPL.

• Tools to easily modify templates to your desired look and feel.

• A drug-form navigator for simplified entry of required drug related data.

• A web service interface for automated population of drug-related data.

• Automated previews of labels with the FDA stylesheet in HTML and PDF.

• The exclusive SPL Checker™ that guides the user towards a conforming label.

• Automated packaging of the label files for upload to your DMS, inclusion in an eCTD, and import into your preferred publishing tools.

The Xpress XML SPL Accelerator is designed to support your preferred platform for document storage and management. This Accelerator may be used to create an interim repository for storing SPL files or to simplify integration to your strategic document management platform. Available platforms include:

• Documentum Edition, which includes a pre-configured application for management and reuse of XML components and associated files. This may be used as an interim solution in a separate DocBase.

• SharePoint Edition, which includes a pre-configured Windows SharePoint Services environment with add-in applications that provide management and reuse of XML components and associated files, version management, advanced access control, and collaborative features.

• Database Edition, which allows organizations to use either SQL Server or Oracle alone while gaining features that are similar to the SharePoint Edition.