Ask a regulatory team which manufacturing sites are approved for a product in each market, and the answer usually comes from a tracker. Ask whether the tracker matches the latest approved dossier, and the honest answer is often “we think so.”
Key takeaways
- RIM data is a second copy of facts already in your filed documents.
- Any second copy typed by hand will drift from the first.
- Point every fact at its source document, and flag differences from the dossier.
- The most valuable link is to quality change control.
The record behind every registration
Regulatory information management (RIM) is the record of what you have filed and what has been agreed: applications and registrations in every country, submissions and their acknowledgements, correspondence and commitments, the product data behind each registration, labeling, and the changes that affect them. Our guide to RIM covers the whole picture.
Almost every fact in that record already exists somewhere else — in an approval letter, a form, a Module 1 document or a Module 3 section. RIM is, in practice, a second copy.
Why the copy drifts
Second copies drift because they are maintained by hand, at a different time, by different people. A sequence removes a manufacturing site; the tracker still lists it. A variation adds a strength in three markets; two are updated. An agency agrees a post-approval commitment in a meeting; it lives in the minutes until it is overdue. The same substance is spelled one way in publishing, another in the RIM system, and a third in quality.
Each gap is small. Together they mean the record cannot be trusted for the questions it exists to answer: what is approved where, what is due when, and what a proposed change will affect.
How to spot drift
- Compare against the latest approved dossier. For a sample of products, check sites, strengths and pack sizes in the RIM record against the current view of the filed application.
- Trace a commitment. Pick a post-approval commitment and find the letter or minutes it came from. If nobody can, the record is not traceable.
- Run a change through it. Ask which registrations a change to one manufacturing site affects. If the answer depends on who you ask, the data is not doing its job.
A record nobody can trace to its source is an opinion, not a record.
How to keep it true
Derive, then confirm. Extract facts from the documents you file and receive — approval letters, forms, regional documents — and have a person confirm them, instead of typing them again.
Point every fact at its source. Every registration fact should link to the filed or approved document it came from, so anyone can check it.
Flag differences. When the RIM record and the latest dossier disagree, someone should be told, not discover it in an audit.
Define product data once. Products, substances, strengths and sites should be one set of records used by publishing, RIM and quality alike.
Connect to change control. The most valuable RIM integration is usually with quality change control, so that a manufacturing or specification change lists every registration it affects at the start of the change, not at the end.
How DnXT approaches it
DnXT connects submission planning, publishing, registrations, correspondence and labeling around the documents you file. Product data is defined once, and registration facts point back to the documents they came from, so the record and the dossier stay in step.
RIM that comes from your dossier
See how registration data, correspondence and change control connect to what you filed.
