The pharma industry is no stranger to standards. Pharmaceutical companies have entire teams devoted to ensuring that all data and content is collected, created, managed, retained, and retired according to regulatory requirements. Many of those legal requirements have associated standards to help everyone manage characteristics such as:
- Terminology
- Data formats
- File formats
When everyone adheres to the standards, everyone benefits.
- Regulators know what information to expect and where to expect it. Pharma companies know what information to provide and where to provide it.
- Health care professionals know that the information they access has been reviewed and approved by health authorities.
- Consumers have more access than ever before, as much of the information provided for physicians is now available in the same places where consumer-oriented materials are published.
The more people and places that need the information, the more important it becomes to have standards to help it all fit together.
Are Many Standards Still a Standard?
The key to making standards useful is to ensure that they are interoperable. There are many examples of interoperable standards.
Software developers have long relied on various types of APIs to provide the mapping from one application to another, along with the find-and-fetch of information exchange. In XML, we often use transforms to transfer information between systems that use different standards. (You can learn more about XML and transforms in XML Standards Provide Rigor and Flexibility for Pharma.)
To make sure that the content works wherever it is found, accessed, exchanged, or reused, the content itself must be standardized. If the content is not authored according to content standards, then it doesn’t matter how much technology you throw at it – the resulting output will not hold together.
This is why Content Rules developed the Five Dimensions of Content Standardization Framework™.
Five Dimensions of Content Standardization Framework
Standards are not just for underlying technologies. Content itself must adhere to standards in order for reuse, automation, and information exchange to work. The Five Dimensions of Content Standardization are:
- Output type
- Component
- Paragraph
- Sentence
- Word
Once your content is standardized across all five dimensions, you can be sure that components can be mixed and matched at will, depending on the final output you need to publish or the information you need to exchange. The components will also flow from one to the next without anyone detecting different authors or locations. All components integrate seamlessly to form your final output.
Additionally, each individual component can stand alone. If a system or person requests a single piece of information, the component can be retrieved and delivered quickly. There is no need to lock the information into a full document. With standardized content, you can deliver just one necessary “chunk” of information, or compile the chunks of information into a longer document, or both.
Put Standardized Content to Work
Once the content is standardized along every dimension, you can put it to work. Standardized content enables many of the capabilities promised by digital transformation:
- Automate content generation, assembly, formatting, and publishing
- Reuse content in any output type or file format
- Deploy artificial intelligence to gain actionable insights
- Exchange information directly with partners, CROs, sites, and regulatory agencies without locking it into documents first
- Increase translation quality while significantly reducing cost and turnaround time
It’s Not Just the Data
Scientists and engineers know the value of creating and following common standards. Standards allow data to be mixed and matched seamlessly, or provided with pinpoint accuracy, depending on the specific situation. Content standards do the same for content.
To learn more about the Five Dimensions framework, download our white paper The Five Dimensions of Content Standardization™: Making Your Reuse and Automation Strategy a Success.
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