It still surprises me that in an industry such as life sciences where quality, compliance and accuracy is of utmost importance, data that can be automatically handled is managed manually. Manual data management is prone to errors, is time consuming and is sometimes even a risky approach of dealing with information across different business functions. Companies that already use Regulatory Information Management (RIM), manage most of the data such as marketing application, excipient and indication in electronic format. So why manually transfer – and thereby copy – data that is already managed in RIM systems in electronic format to an SPC (Summary of Product Characteristics), medicinal product packaging or the Package Information Leaflet (PIL)? This just increases the risk of data inconsistencies, leading to marketing applications updates or even medicinal product recalls.

So how might structured authoring eliminate this issue?

Let’s face it, if the data is already manged in RIM, why not reuse it elsewhere? Let’s look at some examples: medicinal product name, indication, and excipient are already in use when compiling marketing applications in eCTD format. Some of the data is even used to build the eCTD backbone.

Now checking on the EMA QRD template (version 10.2, Rev.1 09/February/2021 ), it contains the same information: the name of medicinal product (section 1), the therapeutic indications (section 4.1) and a list of excipients (section 6.1). If we already manage the same data in RIM for the eCTD, why not reuse the same data to generate the SPC or PIL?

When we think about authoring, we think about medical writers, scientific documents or tools such as an editor. And how do we create structure in a document? We might refer to templates that define the look and feel of a document but also define how paragraphs, fonts or headings are laid out. The most important part though, the content, is still authored manually. This process creates unstructured data inside documents, one of the major challenges recently identified during the implementation of IDMP. Using structured authoring, documents can be automatically created by reuse of data.

The benefit of structured authoring.

Most companies are still copying the data from RIM systems or spreadsheets to SPC or PIL. A manual error prone process that can be avoided using the method of structured authoring. Using this method, data is inserted into documents automatically, even keeping a record for future life cycle. This process not only ensures data consistency across business functions but also provides the opportunity to share data from a ‘single place of truth’. Documents can be partly filled in automatically, thereby reducing manual more error prone tasks, and at the same time creating uniform content. In a regulated environment such as life sciences this is one of the key areas, supporting production and management of quality medicinal products. Quality is what gives patients and consumers confidence in their next dose of medicine. CDER’s KASA approach would be a prime target for structured data but more on that in a future post.

If you need further information, please do not hesitate to get in touch.

Published by Olaf Schoepke

Passionate about sharing ideas with regulatory professionals in the human and veterinary medicinal product space.

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