At a glance
| Input | Mapping result | What remains visible | Limit |
|---|---|---|---|
| Selected Regulation | Each catalog term is matched by name or synonym | Required term and control references | Matching is case-insensitive; it does not compare semantic meaning |
| Consumer Space (optional) | Results use that space, global terms, and subscribed source spaces | Matched term and its status | All spaces (global) uses the full loaded glossary |
| Matched glossary record | Status is approved, draft, or review | Matched Term and Status | Only approved matches count toward Readiness |
| No matching record | Status is missing | Required term and controls | The mapper does not create the missing term |
| Required term shared by two or more catalogs | Catalog references are compared with scoped glossary matches | Regulation titles and controls | A conflict appears only when two or more non-empty definitions differ |
| Different definitions for the shared term | Cross-Regulation Definition Conflicts lists every matched record | Term, status, space, and definition | The app does not merge or overwrite either record |
| Administrator-supplied catalog | Save Custom Mapping adds its terms and controls to the mapper | Custom catalog title and control references | JSON needs a key, title, and at least one required term with a control |
How it works
- Open Requirements Mapper.
- Select a Regulation.
- Select Consumer Space (optional) when the review is space-specific.
- Read Readiness, Approved Required, Needs Approval, and Missing Terms.
- Review the selected catalog's Term Mapping table.
- Check Cross-Regulation Definition Conflicts.
- Compare Regulations with Glossary Records before changing any definition.
Example
“Audit trail” belongs to the FDA catalog under §11.10(e) and the ALCOA+ catalog under 21 CFR Part 11. A QUALITY record defines it as a chronological electronic record. A subscribed GXP record uses “Audit trail” as a synonym but gives it a different definition. The conflict table shows both catalog references and both glossary records. Neither definition is changed.
What this does not mean
The mapper is a name-and-synonym coverage check. It does not establish legal equivalence between regulatory terms. It does not decide which definition is correct. It does not certify compliance. A zero-conflict result can also mean that only one definition was found. Review the underlying catalog references and governed glossary records before approving terminology.
Related questions
Next step
Open Requirements Mapper, select one regulated scope, and resolve every displayed definition conflict with the responsible term owners.
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