Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
Mappings for the mfg-test-site-organization resource profile.
MfgTestSiteOrganization |
Organization | Entity, Role, or Act,Organization(classCode=ORG, determinerCode=INST) |
meta | |
id | n/a |
extension | n/a |
text | Act.text? |
contained | N/A |
extension | N/A |
modifierExtension | N/A |
identifier | .scopes[Role](classCode=IDENT) |
id | n/a |
extension | n/a |
use | Role.code or implied by context |
type | Role.code or implied by context |
system | II.root or Role.id.root |
value | II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) |
period | Role.effectiveTime or implied by context |
assigner | II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper |
identifier (DUNSNumber) | .scopes[Role](classCode=IDENT) |
id | n/a |
extension | n/a |
use | Role.code or implied by context |
type | Role.code or implied by context |
system | II.root or Role.id.root |
value | II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) |
period | Role.effectiveTime or implied by context |
assigner | II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper |
identifier (FEINumber) | .scopes[Role](classCode=IDENT) |
id | n/a |
extension | n/a |
use | Role.code or implied by context |
type | Role.code or implied by context |
system | II.root or Role.id.root |
value | II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) |
period | Role.effectiveTime or implied by context |
assigner | II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper |
active | .status |
type | .code |
name | .name |
alias | .name |
description | .playingEntity[classCode=PLC determinerCode=INSTANCE].desc |
contact | .contactParty |
id | n/a |
extension | n/a |
address | n/a,AD |
partOf | .playedBy[classCode=Part].scoper |
endpoint | n/a |
qualification | n/a |
id | n/a |
extension | n/a |
modifierExtension | N/A |
identifier | n/a |
code | n/a |
period | n/a |
issuer | n/a |
MfgTestSiteOrganization |
Organization | Organization |
identifier | ./Identifiers |
system | ./IdentifierType |
value | ./Value |
period | ./StartDate and ./EndDate |
assigner | ./IdentifierIssuingAuthority |
identifier (DUNSNumber) | ./Identifiers |
system | ./IdentifierType |
value | ./Value |
period | ./StartDate and ./EndDate |
assigner | ./IdentifierIssuingAuthority |
identifier (FEINumber) | ./Identifiers |
system | ./IdentifierType |
value | ./Value |
period | ./StartDate and ./EndDate |
assigner | ./IdentifierIssuingAuthority |
active | ./Status (however this concept in ServD more covers why the organization is active or not, could be delisted, deregistered, not operational yet) this could alternatively be derived from ./StartDate and ./EndDate and given a context date. |
type | n/a |
name | .PreferredName/Name |
contact | |
address | Address |
partOf | n/a |