Structured content in life sciences
A 2017 piece on why pharma's compliance burden makes structured content management a business-process question, not a tooling question. Still holds in 2026.
Originally written by Steffen Frederiksen, August 2017. Lightly refreshed in 2026.
Pharma is undergoing tectonic shifts regarding regulations, affecting both costs and processes across the board. Millions are spent every year by organizations seeking to achieve and retain compliance, one of the biggest challenges facing the life sciences industry.
As the sheer number of regulatory requirements grows worldwide, the challenge of meeting the requirements, and maintaining consistency and integrity across all submissions, becomes ever greater. Life sciences organizations are under pressure to embed compliance into business processes rather than address it after the fact. Quality, consistency and compliance issues need to be caught in real time, before they trickle downstream.
How can life sciences organizations keep up with regulations that are constantly updated or re-evaluated, all while keeping consumer health and safety at the forefront? The answer lies in how information is created and used.
Traditional methods of creating and storing entire documents for submission do not help when a regulation is changed, or when the same information has to be part of multiple submissions in different formats. Organizations can only stay nimble if their information has been created in an agile and highly organized environment. Structured content helps organize information in an efficient, well-ordered way, making it simpler to maintain compliance with changing standards.
Take labeling as a concrete example.
The value of structure in organizing labeling content
Information required to label a given product comes from many different sources, which often complicates the process. For most companies, this information is unstructured, so the process of searching for or reusing it for labeling purposes is lengthy and riddled with potential errors. New ways of making the information useful (eLabels, chatbots, downstream data feeds) add to the complications. Creating a centralized location for storing and structuring that data is what keeps retrieval and reuse efficient and accurate.
If data is separated into logical parts, document maps can be built that reuse information across all products. Only one location needs to be revised for all other documentation to be automatically refreshed the next time a map is published.
When a company structures their compliance information (Company Core Datasheet (CCDS), Company Core Safety Information (CCSI), SOPs) they add real value to their business processes. They get consistency and efficiency by maintaining a single piece of content reused across many areas rather than multiple versions susceptible to error. The same source can also feed operational systems (instructions on how to sterilize a piece of equipment, for instance) and downstream consumers like chatbots.
Data got databases. Content did not.
It is important for companies in pharma and life sciences to consider the value of structured information. As the healthcare industry continues to navigate the shift to meet more stringent compliance regulations, often in real time, further challenges and opportunities for error will arise. Structured content management is one of the strongest tools for working through these new developments.
Relational SQL databases brought huge improvements to all data-related processes in companies. Now it is time to bring the same improvements to content processes. Structured content management is how that gets done.
What changed by 2026
The 2017 argument was that compliance has to be built into how content is created, not inspected after the fact. The regulatory direction since then has made that less of a preference and more of a precondition.
Three shifts matter. The US FDA Quality Management System Regulation (QMSR), effective 2 February 2026, aligns medical-device quality systems with ISO 13485 and tightens traceability across clinical and post-market documentation. The EMA’s ISO IDMP program treats medicinal-product information as identified data rather than prose, with the substance and product layers now in use and the back-catalog window closing. And ICH M11 is finalizing a harmonized, structured template for clinical trial protocols. Each assumes the underlying content is already componentized, governed and traceable.
The consequence for a labeling team
For a labeling or regulatory team the consequence is direct. A Company Core Datasheet held as a document cannot feed an IDMP data layer or refresh a market label without manual re-keying, and every re-key is an audit risk. The same datasheet held as governed components can. That is the case the 2017 piece made in general terms; the 2026 standards make it specific. The current expression of the argument in the platform is on the Life Sciences industry page, and the standards convergence is covered in the SPL, IDMP and eCTD buyer’s guide.
Frequently asked questions
Why does structured content matter more in life sciences than elsewhere?
Because the same approved statement appears in many places (labels, pack inserts, regulatory submissions, training materials) across many markets and many languages. Document-centric handling means those copies drift apart between updates. The audit failure mode is then 'the safety language in this market is not the same as the approved CCDS', which is a structural problem the document model cannot solve.
What is a Company Core Datasheet (CCDS)?
A Company Core Datasheet is the pharmaceutical sponsor's internal reference document containing all approved labeling information for a product: indications, contraindications, dosing, safety statements, pharmacology. Every market-specific label is supposed to derive from the CCDS. When the CCDS changes (typically because of a pharmacovigilance signal or regulatory update), every downstream label should refresh from it. Component content management makes that refresh structural rather than manual.
What changed between 2017 and 2026?
The regulatory environment got stricter. FDA QMSR (effective February 2026) aligned US medical-product quality systems with ISO 13485 and tightened traceability requirements across clinical and post-market documentation. EU MDR/IVDR brought parallel tightening for medical devices. ICH M11 is finalizing as the harmonized international standard for clinical trial protocols. Each of these shifts assumes the underlying content is structured, governed, and traceable, exactly the case the post argued in 2017.
