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Creating Pharmaceutical Structured Product Labels Using the Microsoft Office System

Create Structured Product Labels (SPL) in XML faster, easier, and in compliance with Food and Drug Administration (FDA) requirements with the tools workers use everyday in the Microsoft Office System. These Office tools automatically convert a document into XML-based SPL that conforms to FDA regulations. Once XML-enabled, pharmaceutical companies can then integrate all information and business process silos, eliminate operational complexities and costs associated with global product labeling, and take new drugs to market faster.

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On This Page
  Situation
  Solution
  Benefits


Situation

The pharmaceutical industry is facing a sweeping change associated with how companies report key information to the FDA. The SPL regulation, introduced in 2003, requires pharmaceutical companies to report key product label information in a structured format to the FDA. Today, this information is usually delivered through e-mail as a document attachment—to comply with the SPL regulation it will have to be delivered as an XML document that follows a very specific and structured format. Pharmaceutical companies will be required to determine the best approach to solving this challenge. Today, there is a great opportunity for companies to use the tools and technologies they already have—the Microsoft Office System—to help address this new process they are being required to develop.


Solution

An SPL solution based on the Microsoft Office System helps companies conform to FDA regulations, improves their time to market, and improves their operational efficiency. Specifically, a solution will help address the SPL challenges by delivering:

Easy, familiar authoring. An SPL solution built on the Microsoft Office System provides an easy, familiar environment for end users to create structured SPL documents. Not only will utilizing existing tools and technologies keep training costs low, but it keeps end user disruptions to a minimum. Users can continue to utilize the tools that they know and understand.

Consistent, structured content. Much of the SPL format is about structure, and making sure the structure is consistent and compliant. With the new XML support in Office 2003, this structure can be automatically enforced.

Integrated content re-use. An SPL solution built on Office can integrate easily with other systems like Microsoft SharePoint Products and Technologies, or other content and data systems already in use inside a company. By using existing centralized document repositories, SPL documents are more likely to use the latest, most up-to-date information.


Benefits

By adopting an SPL solution based on the Microsoft Office System, pharmaceutical companies will be able to:

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Conform to regulatory and compliance requirements.

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Decrease their time to market.

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Improve overall operational efficiency.


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If you have a solution based on the Microsoft Office System, learn more about opportunities to showcase your solution with Microsoft.

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