Microsoft Office based authoring for FDA's Structured Product Labeling (SPL) submissions

Managing and submitting labeling information is an inherently complex process. Drug related data encompasses a wide range of processes and systems-from clinical trials, in-house document management systems and internal notes-to FDA reviews and approvals; followed by dissemination to internal and external agencies such as the FDA, the Daily Med system, pharmacies, patients and even the life sciences companies' own Web sites. Ensuring data accuracy, consistency, and comprehension across time and space of such magnitude is a tremendous challenge.

To add to this complexity, the FDA has begun accepting labeling submissions for prescription drugs, not just in PDF (which has been the practice so far), but in a new format called Structured Product Labeling (SPL). By the end of 2007, the requirement to submit labeling information in SPL will extend to all FDA-regulated products: OTC medications, devices, diagnostics, veterinary medicines-any product with package information or a package insert.

A major challenge is how to incorporate an existing software investment in Microsoft Office into a solution. GrapeCity has developed a technology that enables a document author to utilize the familiar Microsoft Office programs, such as Word and Excel, to create structured SPL content without worrying about the underlying data format as shown in Diagram #1.

Based on this technology, it is possible to identify and manage the various elements of the drug labeling information. Once the elements are identified, the content authoring process defined, and the participating users and their roles established, the technology can power any portal solution through which drug information can be intelligently authored, analyzed and managed in a controlled manner.

Any changes in the drug information can also be converted back into the Microsoft Office format, thus "closing the loop" within the drug information life cycle.

By adopting GrapeCity's MS Word-SPL Engine and leveraging Microsoft technologies such as Microsoft .NET, Office, SharePoint Web Services and SQL Server, life science companies can take advantage of this next-generation drug information management solution.

• Drives FDA compliance from the ground up. Author, review and submit onlythose sections or data elements that have changed within a large document.
• Reduces cost and complexity of FDA submissions by defining a consistent, predictable means of exchanging labeling content by utilizing a fully internationalized, flexible, open standard.
• Assists in enforcing Current Good Manufacturing Practice (cGMP) and Good Lab Practice (GLP) compliance for laboratory and manufacturing facilities.
• Allows downward compatibility with existing content and future integration with upcoming FDA initiatives in Life Sciences and Healthcare, such as e-transcription and electronic medical records (EMR).
• Leverages SPL-based metadata technology that enables potential semantic analysis of drug data which remains a dream for the industry.

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