LSCP & Partner Thought Leadership
Many years ago, we have deeply looked into Structured Component Authoring (SCA). We have come to the conclusion that industry and regulators alike could leverage what was done in other domains (Car, Discrete Manufacturing, Aircrafts etc.): Too much of a «big bang» and now regulatory pressure. But again, challenges have changed to revisit! Here is an example to review such approach in context of forthcoming, mandatory ISO standards.
Together with our Partner STAR Group we want to give the semantic information management a spot and share with you a «tangible» thought:
If you want to develop and manufacture a drug, you need the active and non-active substances (IDMP+ Unique Substance Code), a shape, the dosage, a form (any type) and a recipe describing the manufacturing process etc. This knowledge is acquired in the drug development process. With this you can produce a large amount of medicinal product with a specific dose.
If you need to produce the drug with another dose, you change the recipe accordingly and produce e.g. a new strength. This is the most efficient way. It would be very inefficient to take the already produced product, decompose them take the substances back into production for the new one with a new dosage.
With a document centric approach, information is handled as a produced drug. The information is packaged in a specific form – the document. If you need the same information in a different context or documents you manually decompose the information from the document (form) and put it into the other document (new form). This process is as inefficient as decomposing a medicinal product to manufacture another one.
The GRIPS Semantic Information Management allows you to handle the information like you produce your dosage forms today. The information can be seen as the substances. The information model is like the recipe. The publishing engine is the production process for a specific form. If you need the information in other forms it’s an automated process.
Florian von Lepel, STAR GRIPS Chief Architect
IDMP+ refers to ISO IDMP, ICSR & SPL Standards