Life Sciences

If you make prescription, generic, animal, biologic, and over-the-counter pharmaceuticals, you face increasing requirements for XML-based regulatory submissions such as Structured Product Labeling (SPL), Product Information Management (PIM), and Electronic Common Technical Documents (eCTD).

But what's the best way to achieve compliance? Should you outsource compliance to a third party? Should you adapt your processes so you can achieve compliance on your own? And if XML offers time-to-market and efficiency improvements to regulatory authorities, can you achieve similar benefits by applying XML to many of your internal processes?

Quark can help you adopt a cost-effective XML strategy to meet regulatory requirements through:

• An out-of-the box SPL solution
• Easy XML authoring technology for PIM implementations
• Automating and streamlining the eCTD process to speed up new drug submissions

The Case for XML

Regulators have already started making the switch from a document focus to a content focus: Instead of (or in addition to) asking for documents, they're asking for information in an XML format. They're making this change for two reasons. First, they want a faster, more efficient process of bringing new and beneficial drugs to market. And second, they want to improve the accuracy of public-facing information such as labeling because of its impact on patient safety.

XML supports these goals in two ways:

• First, XML lets you prescribe rules for the structure and content of a document and guide authors to comply with those rules. If you create information in an absolutely consistent format, you can set up automated systems to process that information. The most common automated process is collecting information components and publishing them as finished documents.
• Second, XML lets you create information in reusable components, so that you can maintain a single instance of information that you can use in multiple documents. If that information changes, all of the documents that refer to it can be updated automatically.

XML for All of Your Documents

You can take advantage of these XML characteristics not only for regulatory submissions, but also for all of your formal documents, such as required to bring new drugs to market including marketing materials. You can free your authors to focus their energy on creating information, instead of laying out pages and applying formatting. Your authors can reuse information instead of re-creating it or copying and pasting it. By maintaining a single source of information, you can improve accuracy as well as efficiency.

How Will You Comply with XML Requirements?

To produce XML information that complies with regulatory requirements, you can outsource it or you can do it yourself. You could hire a third party to convert your product and labeling information for you. Outsourcing is simple, but outsourcing the conversion of existing materials gives external parties access to your information — which can create conflicts of interest, especially for first-to-file submissions. Or, you could change your internal processes to produce the XML yourself. In doing so, you could cut costs instead of adding costs.

Quark's XML Solution

While XML implementation has traditionally meant adopting proprietary and complex XML editing tools, Quark offers a simpler way. Quark XML Author for Microsoft Word, an add-in to Word, lets your authors easily create structured content in the familiar Word environment. By authoring structured XML content in Word, you can easily reuse that information in multiple documents, automatically assemble it into publications, and automatically publish it to multiple types of media — with minimal training and disruption. This improves information accuracy, speeds up your publishing process, and reduces overall publishing costs.

Next Steps