To ensure that you meet regulatory requirements for information delivery, you need to know what content must be included in your information products. This varies greatly by industry, regulatory agency, and locale. (For example, the European Union may have different rules than the United States.)
Once you determine the content requirements, you need a content strategy that ensures that you always deliver the required content. For new drug applications, for example, you may be required to include detailed information about clinical trials in a specific format. That implies advance planning years before the application is submitted to an entity like the U.S. Food and Drug Administration.
From a content strategy point of view, you want to make sure that the appropriate information is being collected, and is available to be processed into the information product required by the regulatory body.
Although reuse is encouraged in most technical content, it may be problematic in regulatory submissions because you do not want to change a document that has already been submitted. Therefore, you may need to break the link between the original file and the reused content to ensure that any updates do not change the source document.
- Audit trails for content changes and reviews. You may need a system that allows you to audit changes after the fact. Some organizations use cumbersome manual processes to create audit trails, but software is available that can automate this process.
- Change tracking. You may need the ability to deliver content updates with all changes marked so that regulators can easily identify differences from one version to the next.
- Traceability. You may need to be able to show the roots of each piece of content, so that you can justify its accuracy.