Data Administration Selection Lists: Product Maintenance
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Calyx RIM. Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
|---|---|
| Applicable Standards Values | Client Defined |
| Conformity Assessment Body Values | Client Defined |
| Conformity Assessment Path Values | Calyx Defined: Best Practices |
| Device Allergenicity Values | Client Defined |
| Device Classification Values | FDA; EMA |
| Device Nomenclature Values | Client Defined |
| Device Sterility Indicator Values | Client Defined |
| Device Type Values | Client Defined |
| Device Usage Values | Client Defined |
| Dosage/Pharmaceutical Form Values | XEVMPD Controlled Vocabularies – Pharmaceutical Dose Forms |
| EC Cert Values | Client Defined |
| EU Classification Rule Values | EMA |
| FDA Regulation Number Values | FDA |
| Global Harmonization Task Force (GHTF) Class Values | GHTF |
| Manufacturing Location Values | Client Defined |
| Medical Device Values | XEVMPD Controlled Vocabularies – Medical Devices |
| Product Characteristics Values | Client Defined |
| Product Status Values | Calyx Defined: Best Practices |
| Product Strength Unit Values | Client Defined |
| Route of Administration Values | XEVMPD Controlled Vocabularies - Routes of Administration |
| Special Measure Values | Client Defined |
| Sterilization Requirement Values | Client Defined |
| Sterilization Values | Client Defined |
| Summary of Technical Documentation (STED) Values | Client Defined |