Line 1,392: |
Line 1,392: |
| ! scope="col" style="width: 350px;" |Comments | | ! scope="col" style="width: 350px;" |Comments |
| |- | | |- |
| + | |OBS_ID |
| + | |VARCHAR2(36 CHAR) |
| + | |Primary |
| + | |No |
| + | |NULL |
| + | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 |
| + | |This is the unique record identifier for the observation. |
| | | | | |
| + | |- |
| + | |OBS_NUM |
| + | |VARCHAR2(200 CHAR) |
| + | | |
| + | |No |
| + | |NULL |
| + | |00070-MDCCD HEALTHCARE INC -obs0001132 |
| + | |This is the observation number. |
| + | | |
| + | |- |
| + | |INSP_ID |
| + | |VARCHAR2(36 CHAR) |
| + | |Foreign |
| + | |No |
| + | |NULL |
| + | |5c6afa3c-3f8a-4641-8da4-9588ec7769d7 |
| + | |This is the unique record identifier for the parent inspection. |
| + | | |
| + | |- |
| + | |INSP_NUM |
| + | |VARCHAR2(200 CHAR) |
| + | |Foreign |
| + | |No |
| + | |NULL |
| + | |00070-MDCCD HEALTHCARE INC |
| + | |This is the parent inspection number. |
| + | |- |
| + | |OBS_TYPE_EN |
| + | |VARCHAR2(200 CHAR) |
| + | | |
| + | |Yes |
| + | |NULL |
| + | |MDR - Establishment licence |
| + | |This identifies the overall category of the Medical Device Regulations that the observation is cited under in English. |
| + | | |
| + | |- |
| + | |OBS_TYPE_FR |
| + | |VARCHAR2(200 CHAR) |
| + | | |
| + | |Yes |
| + | |NULL |
| + | |RIM - Licence d’établissement |
| + | |This identifies the overall category of the Medical Device Regulations that the observation is cited under in French. |
| + | | |
| + | |- |
| + | |REG_SECTION_EN |
| + | |VARCHAR2(150 CHAR) |
| + | | |
| + | |Yes |
| + | |NULL |
| + | |s.45 (f) Device classes |
| + | |This identifies the specific section/subsection of the Medical Device Regulations that the observation is cited under in English. |
| + | | |
| + | |- |
| + | |REG_SECTION_FR |
| + | |VARCHAR2(150 CHAR) |
| + | | |
| + | |Yes |
| + | |NULL |
| + | |MDR s.45 (f) Classes des instruments |
| + | |This identifies the specific section/subsection of the Medical Device Regulations that the observation is cited under in French. |
| + | | |
| + | |- |
| + | |OBS_RISK |
| + | |NUMBER(1,0) |
| + | | |
| + | |Yes |
| + | |NULL |
| + | |1 |
| + | |This identifies the risk level of the observation. |
| + | |Scale 1-3. Risk 1 is the highest and risk 3 is the lowest. |
| + | |- |
| + | |OBS_REPEAT_EN |
| + | |VARCHAR2(30 CHAR) |
| + | | |
| + | |Yes |
| + | |NULL |
| + | |Repeat Observation |
| + | |This indicates if the observation has occurred before on a previous inspection with the company in English. |
| + | | |
| + | |- |
| + | |OBS_REPEAT_FR |
| + | |VARCHAR2(30 CHAR) |
| + | | |
| + | |Yes |
| + | |NULL |
| + | |Observation répétée |
| + | |This indicates if the observation has occurred before on a previous inspection with the company in French. |
| + | | |
| + | |- |
| + | |OBS_STATUS_EN |
| + | |VARCHAR2(50 CHAR) |
| + | | |
| + | |Yes |
| + | |NULL |
| + | |Open |
| + | |This indicates the status of the observation in English. |
| + | |- |
| + | |OBS_STATUS_FR |
| + | |VARCHAR2(50 CHAR) |
| | | | | |
| + | |Yes |
| + | |NULL |
| + | |Ouvert |
| + | |This indicates the status of the observation in French. |
| | | | | |
| + | |- |
| + | |OBS_INCLUDEREPORT_EN |
| + | |VARCHAR2(3 CHAR) |
| | | | | |
| + | |Yes |
| + | |NULL |
| + | |Yes |
| + | |This indicates whether the observation is included on the inspection report in English. |
| | | | | |
| + | |- |
| + | |OBS_INCLUDEREPORT_FR |
| + | |VARCHAR2(3 CHAR) |
| | | | | |
| + | |Yes |
| + | |NULL |
| + | |Oui |
| + | |This indicates whether the observation is included on the inspection report in French. |
| | | | | |
| |- | | |- |
| + | |OBS_SEQ_NUM |
| + | |NUMBER(3,0) |
| | | | | |
| + | |Yes |
| + | |NULL |
| + | |1 |
| + | |This indicates the order that the observations will print on the inspection report. |
| | | | | |
| + | |- |
| + | |OBS_STDLINE_EN |
| + | |VARCHAR2(1000 CHAR) |
| | | | | |
| + | |Yes |
| + | |NULL |
| + | |A written procedure was not provided. |
| + | |This is a standard line related to the section of the regulation cited in English. |
| + | | |
| + | |- |
| + | |OBS_STDLINE_FR |
| + | |VARCHAR2(1000 CHAR) |
| | | | | |
| + | |Yes |
| + | |NULL |
| + | |Une procédure écrite n'avait pas été fournie |
| + | |This is a standard line related to the section of the regulation cited in French. |
| | | | | |
| + | |- |
| + | |OBS_NARRATIVE |
| + | |VARCHAR2(4000 CHAR) |
| | | | | |
| + | |Yes |
| + | |NULL |
| + | |/*A written procedure was not provided. */ |
| + | |
| + | |
| + | The company did not have a written procedure in place for complaint handling. |
| + | |This is the inspector's narrative related to the observation. |
| | | | | |
| |- | | |- |
| + | |OBS_SUMMARY |
| + | |VARCHAR2(2000 CHAR) |
| | | | | |
| + | |Yes |
| + | |NULL |
| + | |Observation #: 01 |
| + | |
| + | Status / Statut : Open / Ouvert |
| + | |
| + | Risk / Risque : 1 |
| + | |
| + | MDR - Establishment licence / RIM - Licence d’établissement |
| + | |
| + | MDR s.45 (f) Device classes / MDR s.45 (f) Classes des instruments |
| + | |
| + | |
| + | /*A written procedure was not provided. */ |
| + | |
| + | |
| + | The company did not have a written procedure in place for complaint handling. |
| + | |This is the overall summary of the observation that built from the above columns. |
| | | | | |
| + | |- |
| + | |CREATEDBYNAME |
| + | |VARCHAR2(100 CHAR) |
| | | | | |
| + | |Yes |
| + | |NULL |
| + | |John Smith |
| + | |This identifies the resource that created the record. |
| + | |- |
| + | |CREATEDON |
| + | |DATE |
| | | | | |
| + | |Yes |
| + | |NULL |
| + | |22-08-26 |
| + | |This identifies the date that record was created. |
| | | | | |
| + | |- |
| + | |MODIFIEDBYNAME |
| + | |VARCHAR2(100 CHAR) |
| | | | | |
| + | |Yes |
| + | |NULL |
| + | |John Smith |
| + | |This identifies the resource that last modified the record. |
| + | | |
| + | |- |
| + | |MODIFIEDON |
| + | |DATE |
| + | | |
| + | |Yes |
| + | |NULL |
| + | |22-08-26 |
| + | |This identifies the date that record was last modified. |
| | | | | |
| |} | | |} |
| | | |
− | ===MD_INS_CASE_WORKFLOW=== | + | |
| + | === MD_INS_CASE_WORKFLOW === |
| [[MDCCD Data Warehouse|Return to Home Page.]] | | [[MDCCD Data Warehouse|Return to Home Page.]] |
| | | |
Line 1,423: |
Line 1,630: |
| {| class="wikitable sortable mw-collapsible" | | {| class="wikitable sortable mw-collapsible" |
| |+ | | |+ |
− | ! scope="col" style="width: 350px;" | Column Name | + | ! scope="col" style="width: 350px;" |Column Name |
| ! scope="col" style="width: 100px;" |DataType | | ! scope="col" style="width: 100px;" |DataType |
| ! scope="col" style="width: 50px;" |Key Type | | ! scope="col" style="width: 50px;" |Key Type |
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| ! scope="col" style="width: 50px;" |Data Default | | ! scope="col" style="width: 50px;" |Data Default |
| ! scope="col" style="width: 500px;" |Example Data | | ! scope="col" style="width: 500px;" |Example Data |
− | ! scope="col" style="width: 350px;" | Description | + | ! scope="col" style="width: 350px;" |Description |
| ! scope="col" style="width: 350px;" |Comments | | ! scope="col" style="width: 350px;" |Comments |
| |- | | |- |
Line 1,457: |
Line 1,664: |
| |} | | |} |
| | | |
− | ===MD_INS_INS_IID=== | + | ===MD_INS_INS_IID === |
| [[MDCCD Data Warehouse|Return to Home Page.]] | | [[MDCCD Data Warehouse|Return to Home Page.]] |
| | | |
Line 1,463: |
Line 1,670: |
| {| class="wikitable sortable mw-collapsible" | | {| class="wikitable sortable mw-collapsible" |
| |+ | | |+ |
− | ! scope="col" style="width: 350px;" | Column Name | + | ! scope="col" style="width: 350px;" |Column Name |
| ! scope="col" style="width: 100px;" |DataType | | ! scope="col" style="width: 100px;" |DataType |
| ! scope="col" style="width: 50px;" |Key Type | | ! scope="col" style="width: 50px;" |Key Type |
Line 1,469: |
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| ! scope="col" style="width: 50px;" |Data Default | | ! scope="col" style="width: 50px;" |Data Default |
| ! scope="col" style="width: 500px;" |Example Data | | ! scope="col" style="width: 500px;" |Example Data |
− | ! scope="col" style="width: 350px;" | Description | + | ! scope="col" style="width: 350px;" |Description |
− | ! scope="col" style="width: 350px;" |Comments | + | ! scope="col" style="width: 350px;" | Comments |
| |- | | |- |
| | | | | |
Line 1,497: |
Line 1,704: |
| |} | | |} |
| | | |
− | ===MD_INS_INS_INSPECTORLIST=== | + | ===MD_INS_INS_INSPECTORLIST === |
| [[MDCCD Data Warehouse|Return to Home Page.]] | | [[MDCCD Data Warehouse|Return to Home Page.]] |
| | | |
Line 1,503: |
Line 1,710: |
| {| class="wikitable sortable mw-collapsible" | | {| class="wikitable sortable mw-collapsible" |
| |+ | | |+ |
− | ! scope="col" style="width: 350px;" | Column Name | + | ! scope="col" style="width: 350px;" |Column Name |
| ! scope="col" style="width: 100px;" |DataType | | ! scope="col" style="width: 100px;" |DataType |
| ! scope="col" style="width: 50px;" |Key Type | | ! scope="col" style="width: 50px;" |Key Type |
Line 1,509: |
Line 1,716: |
| ! scope="col" style="width: 50px;" |Data Default | | ! scope="col" style="width: 50px;" |Data Default |
| ! scope="col" style="width: 500px;" |Example Data | | ! scope="col" style="width: 500px;" |Example Data |
− | ! scope="col" style="width: 350px;" | Description | + | ! scope="col" style="width: 350px;" |Description |
| ! scope="col" style="width: 350px;" |Comments | | ! scope="col" style="width: 350px;" |Comments |
| |- | | |- |
Line 1,537: |
Line 1,744: |
| |} | | |} |
| | | |
− | ===MD_INS_INS_IRC_ENFORCEMENT=== | + | ===MD_INS_INS_IRC_ENFORCEMENT === |
| [[MDCCD Data Warehouse|Return to Home Page.]] | | [[MDCCD Data Warehouse|Return to Home Page.]] |
| | | |
Line 1,543: |
Line 1,750: |
| {| class="wikitable sortable mw-collapsible" | | {| class="wikitable sortable mw-collapsible" |
| |+ | | |+ |
− | ! scope="col" style="width: 350px;" | Column Name | + | ! scope="col" style="width: 350px;" |Column Name |
| ! scope="col" style="width: 100px;" |DataType | | ! scope="col" style="width: 100px;" |DataType |
| ! scope="col" style="width: 50px;" |Key Type | | ! scope="col" style="width: 50px;" |Key Type |
Line 1,549: |
Line 1,756: |
| ! scope="col" style="width: 50px;" |Data Default | | ! scope="col" style="width: 50px;" |Data Default |
| ! scope="col" style="width: 500px;" |Example Data | | ! scope="col" style="width: 500px;" |Example Data |
− | ! scope="col" style="width: 350px;" | Description | + | ! scope="col" style="width: 350px;" |Description |
| ! scope="col" style="width: 350px;" |Comments | | ! scope="col" style="width: 350px;" |Comments |
| |- | | |- |
Line 1,577: |
Line 1,784: |
| |} | | |} |
| | | |
− | ===MD_INS_INS_IRC_MEASURES=== | + | ===MD_INS_INS_IRC_MEASURES === |
| [[MDCCD Data Warehouse|Return to Home Page.]] | | [[MDCCD Data Warehouse|Return to Home Page.]] |
| | | |
Line 1,583: |
Line 1,790: |
| {| class="wikitable sortable mw-collapsible" | | {| class="wikitable sortable mw-collapsible" |
| |+ | | |+ |
− | ! scope="col" style="width: 350px;" | Column Name | + | ! scope="col" style="width: 350px;" |Column Name |
| ! scope="col" style="width: 100px;" |DataType | | ! scope="col" style="width: 100px;" |DataType |
| ! scope="col" style="width: 50px;" |Key Type | | ! scope="col" style="width: 50px;" |Key Type |
Line 1,589: |
Line 1,796: |
| ! scope="col" style="width: 50px;" |Data Default | | ! scope="col" style="width: 50px;" |Data Default |
| ! scope="col" style="width: 500px;" |Example Data | | ! scope="col" style="width: 500px;" |Example Data |
− | ! scope="col" style="width: 350px;" | Description | + | ! scope="col" style="width: 350px;" |Description |
| ! scope="col" style="width: 350px;" |Comments | | ! scope="col" style="width: 350px;" |Comments |
| |- | | |- |
Line 1,617: |
Line 1,824: |
| |} | | |} |
| | | |
− | === MD_INS_INS_IRC_OBSERVATIONS=== | + | ===MD_INS_INS_IRC_OBSERVATIONS === |
| [[MDCCD Data Warehouse|Return to Home Page.]] | | [[MDCCD Data Warehouse|Return to Home Page.]] |
| | | |
Line 1,623: |
Line 1,830: |
| {| class="wikitable sortable mw-collapsible" | | {| class="wikitable sortable mw-collapsible" |
| |+ | | |+ |
− | ! scope="col" style="width: 350px;" | Column Name | + | ! scope="col" style="width: 350px;" |Column Name |
| ! scope="col" style="width: 100px;" |DataType | | ! scope="col" style="width: 100px;" |DataType |
| ! scope="col" style="width: 50px;" |Key Type | | ! scope="col" style="width: 50px;" |Key Type |
Line 1,629: |
Line 1,836: |
| ! scope="col" style="width: 50px;" |Data Default | | ! scope="col" style="width: 50px;" |Data Default |
| ! scope="col" style="width: 500px;" |Example Data | | ! scope="col" style="width: 500px;" |Example Data |
− | ! scope="col" style="width: 350px;" | Description | + | ! scope="col" style="width: 350px;" |Description |
| ! scope="col" style="width: 350px;" |Comments | | ! scope="col" style="width: 350px;" |Comments |
| |- | | |- |
Line 1,657: |
Line 1,864: |
| |} | | |} |
| | | |
− | === MD_INS_INS_SITE=== | + | ===MD_INS_INS_SITE === |
| [[MDCCD Data Warehouse|Return to Home Page.]] | | [[MDCCD Data Warehouse|Return to Home Page.]] |
| | | |
Line 1,663: |
Line 1,870: |
| {| class="wikitable sortable mw-collapsible" | | {| class="wikitable sortable mw-collapsible" |
| |+ | | |+ |
− | ! scope="col" style="width: 350px;" | Column Name | + | ! scope="col" style="width: 350px;" |Column Name |
| ! scope="col" style="width: 100px;" |DataType | | ! scope="col" style="width: 100px;" |DataType |
| ! scope="col" style="width: 50px;" |Key Type | | ! scope="col" style="width: 50px;" |Key Type |
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| ! scope="col" style="width: 50px;" |Data Default | | ! scope="col" style="width: 50px;" |Data Default |
| ! scope="col" style="width: 500px;" |Example Data | | ! scope="col" style="width: 500px;" |Example Data |
− | ! scope="col" style="width: 350px;" | Description | + | ! scope="col" style="width: 350px;" |Description |
| ! scope="col" style="width: 350px;" |Comments | | ! scope="col" style="width: 350px;" |Comments |
| |- | | |- |
Line 1,697: |
Line 1,904: |
| |} | | |} |
| | | |
− | ===MD_INS_INS_SITE_CONTACT=== | + | ===MD_INS_INS_SITE_CONTACT === |
| [[MDCCD Data Warehouse|Return to Home Page.]] | | [[MDCCD Data Warehouse|Return to Home Page.]] |
| | | |
Line 1,703: |
Line 1,910: |
| {| class="wikitable sortable mw-collapsible" | | {| class="wikitable sortable mw-collapsible" |
| |+ | | |+ |
− | ! scope="col" style="width: 350px;" | Column Name | + | ! scope="col" style="width: 350px;" |Column Name |
| ! scope="col" style="width: 100px;" |DataType | | ! scope="col" style="width: 100px;" |DataType |
− | ! scope="col" style="width: 50px;" |Key Type | + | ! scope="col" style="width: 50px;" | Key Type |
| ! scope="col" style="width: 50px;" |Nullable | | ! scope="col" style="width: 50px;" |Nullable |
| ! scope="col" style="width: 50px;" |Data Default | | ! scope="col" style="width: 50px;" |Data Default |
| ! scope="col" style="width: 500px;" |Example Data | | ! scope="col" style="width: 500px;" |Example Data |
− | ! scope="col" style="width: 350px;" | Description | + | ! scope="col" style="width: 350px;" |Description |
| ! scope="col" style="width: 350px;" |Comments | | ! scope="col" style="width: 350px;" |Comments |
| |- | | |- |
Line 1,737: |
Line 1,944: |
| |} | | |} |
| | | |
− | ===MD_INS_INS_LICENCE=== | + | ===MD_INS_INS_LICENCE === |
| [[MDCCD Data Warehouse|Return to Home Page.]] | | [[MDCCD Data Warehouse|Return to Home Page.]] |
| | | |
Line 1,743: |
Line 1,950: |
| {| class="wikitable sortable mw-collapsible" | | {| class="wikitable sortable mw-collapsible" |
| |+ | | |+ |
− | ! scope="col" style="width: 350px;" | Column Name | + | ! scope="col" style="width: 350px;" |Column Name |
| ! scope="col" style="width: 100px;" |DataType | | ! scope="col" style="width: 100px;" |DataType |
| ! scope="col" style="width: 50px;" |Key Type | | ! scope="col" style="width: 50px;" |Key Type |
Line 1,749: |
Line 1,956: |
| ! scope="col" style="width: 50px;" |Data Default | | ! scope="col" style="width: 50px;" |Data Default |
| ! scope="col" style="width: 500px;" |Example Data | | ! scope="col" style="width: 500px;" |Example Data |
− | ! scope="col" style="width: 350px;" | Description | + | ! scope="col" style="width: 350px;" |Description |
| ! scope="col" style="width: 350px;" |Comments | | ! scope="col" style="width: 350px;" |Comments |
| |- | | |- |
Line 1,777: |
Line 1,984: |
| |} | | |} |
| | | |
− | ===MD_INS_INS_SITELICENCEACTIVITY=== | + | ===MD_INS_INS_SITELICENCEACTIVITY === |
| [[MDCCD Data Warehouse|Return to Home Page.]] | | [[MDCCD Data Warehouse|Return to Home Page.]] |
| | | |
Line 1,783: |
Line 1,990: |
| {| class="wikitable sortable mw-collapsible" | | {| class="wikitable sortable mw-collapsible" |
| |+ | | |+ |
− | ! scope="col" style="width: 350px;" | Column Name | + | ! scope="col" style="width: 350px;" |Column Name |
| ! scope="col" style="width: 100px;" |DataType | | ! scope="col" style="width: 100px;" |DataType |
| ! scope="col" style="width: 50px;" |Key Type | | ! scope="col" style="width: 50px;" |Key Type |
Line 1,789: |
Line 1,996: |
| ! scope="col" style="width: 50px;" |Data Default | | ! scope="col" style="width: 50px;" |Data Default |
| ! scope="col" style="width: 500px;" |Example Data | | ! scope="col" style="width: 500px;" |Example Data |
− | ! scope="col" style="width: 350px;" | Description | + | ! scope="col" style="width: 350px;" |Description |
| ! scope="col" style="width: 350px;" |Comments | | ! scope="col" style="width: 350px;" |Comments |
| |- | | |- |