Structured Product Labeling (SPL)

The pharmaceutical industry has been facing challenges in the way it reports information to the FDA - everything from product information to the standard in which it is delivered must comply with the FDA's Center for Drug Evaluation and Research (CDER). Recently, Dakota Systems has developed various solutions and automated systems to streamline the XML authoring process, along with extending functionality for SPL enterprise search. Dakota Systems has been providing enterprise solutions for the manufacturing industry, and naturally, we realized the benefit our enterprise solutions can provide the healthcare industry in their efforts to comply with FDA standards.

Legacy Systems

The healthcare industry has been struggling to find a solution to utilize product information stored across various legacy systems and in multiple document formats. Compounding this problem is the access end-users have to these particular systems and the inability to use the content once accessed.

SPL Publishing

Adherence to the FDA's XML schema further complicates the process of validating and processing a finalized SPL document. The appropriate technology that a healthcare company must implement to ensure FDA-compliance is often vague and over-complicated resulting in a cumbersome publishing/validation tool. Dakota focuses its effort on dynamic publishing methods from validation to error correctness.

SPL Indexing

Most view indexing of SPL XML content to be emerging technology; however, for Dakota Systems, it's something we have been doing for the last decade. As an industry leader in XML content management systems, we have honed our experience to design efficient XML authoring interfaces, XML databases and customized XML publishing methods. The FDA is working on a standard indexing scheme for all SPL and it makes sense to have those crucial elements support any structured product label - across all healthcare industries.

Our Goal:

• Comply with FDA SPL XML Standards
• Increase Authoring and Operational Efficiency
• Optimize Time to Market
• Bring Re-Use to the Forefront of SPL Authoring
• Provide Efficient Enterprise Search
• Publish Dynamically Validated SPL Documents to the FDA's Center for Drug Evaluation and Research (CDER)