SHAPE is linking and integrating bi-directionally structured content (e.g. IDMP records) with text, presentation or PDF files (e.g. eCTD word documents).

Users are assisted in writing and structuring with a toolbar bringing structured contents at their fingertip.

SHAPE permits to compare consistency between structured sources and documents.

SHAPE permits to lock structured sources to documents and enables a bi-directional change propagation with deep / un-deep binding.

Regulatory business processes encompass highly complex data in stringent relationships, building multilevel hierarchies. The IDMP data model is a perfect illustration: ISO defined data structures must be intertwined with existing CMC data models. “Seeing” relationships build screen by screen in transactional User Interfaces is not a common gift. CR-ME unifies relationships in a single meaningful eagles’ perspective, allowing drill down to transactional interaction.

One can rephrase the above: A drawing is worth a thousand words.

Verification of data consistency between unstructured documents (e.g. word…) and data recorded in systems (e.g RIMS…). Example for healthcare industry , the SmPC content (Summary pf Product Characteristics) is compared to the registration details and to IDMP content. Discrepancies are presented and can be updated based on human decision.

In addition to data consistency check, based on a master, data can be updated wherever decided, in the system, in the unstructured document …

Based on identified manufacturing changes and thanks to the structured data – documents association, automatically analyse the regulatory impact (where to submit), identify the documents impacted (what to submit) and prepare the submissions structures (how to submit).