Life Sciences

Regulatory Labeling and FDA Compliance

Product labeling in the pharmaceutical and medical device industry is a highly regulated and complex process. The product label can include multiple documents targeted at diverse audiences such as patients, physicians and pharmacists. A product label is very specific and precise in its content, especially with respect to safety data and adverse effects. Furthermore, the label needs to comply with country-specific regulations governing the product.

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 years of experience providing structured authoring and labeling solutions for the companies in the life sciences field, including Abbott, GE Healthcare, SCIEX, and Eli Lilly.

What is Structured Product Labeling (SPL)?

SPL is an HL7 standard that defines the content and structure of product labeling information required for submission to the FDA. It improves the integrity of product information through the use of consistent structure and standard terminology. It is used as the basis for regulatory guidance documents and applications for exchange of product labeling content.

Dakota 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 while Designing and Producing Physician Labeling
  • 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)

Why SPL?

The primary reason for creating the SPL specification was to ensure a uniform approach to developing labeling content. Through the use of a standard, structured format, measurable improvements can be achieved throughout the creation, review, approval and overall management and distribution of labeling content by both industry and health authorities. Labeling is a critical aspect of product life cycle management. With the complex approval procedure for products, content and size of labeling documents in the industry are also strictly regulated. Even after introducing the product into the market, these documents need to be continuously updated.

Legacy Systems

The healthcare industry has been struggling to find a solution to use 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.

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