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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.]]
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{| 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
 
|-
 
|-
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|}
 
|}
   −
===MD_INS_INS_IID===
+
===MD_INS_INS_IID ===
 
[[MDCCD Data Warehouse|Return to Home Page.]]
 
[[MDCCD Data Warehouse|Return to Home Page.]]
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{| 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
 
|-
 
|-
 
|
 
|
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|}
 
|}
   −
===MD_INS_INS_INSPECTORLIST===
+
===MD_INS_INS_INSPECTORLIST ===
 
[[MDCCD Data Warehouse|Return to Home Page.]]
 
[[MDCCD Data Warehouse|Return to Home Page.]]
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{| 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
 
|-
 
|-
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|}
 
|}
   −
===MD_INS_INS_IRC_ENFORCEMENT===
+
===MD_INS_INS_IRC_ENFORCEMENT ===
 
[[MDCCD Data Warehouse|Return to Home Page.]]
 
[[MDCCD Data Warehouse|Return to Home Page.]]
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{| 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
 
|-
 
|-
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|}
 
|}
   −
===MD_INS_INS_IRC_MEASURES===
+
===MD_INS_INS_IRC_MEASURES ===
 
[[MDCCD Data Warehouse|Return to Home Page.]]
 
[[MDCCD Data Warehouse|Return to Home Page.]]
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{| 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
 
|-
 
|-
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|}
 
|}
   −
=== MD_INS_INS_IRC_OBSERVATIONS===
+
===MD_INS_INS_IRC_OBSERVATIONS ===
 
[[MDCCD Data Warehouse|Return to Home Page.]]
 
[[MDCCD Data Warehouse|Return to Home Page.]]
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{| 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
 
|-
 
|-
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|}
 
|}
   −
=== MD_INS_INS_SITE===
+
===MD_INS_INS_SITE ===
 
[[MDCCD Data Warehouse|Return to Home Page.]]
 
[[MDCCD Data Warehouse|Return to Home Page.]]
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{| 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
 
|-
 
|-
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|}
 
|}
   −
===MD_INS_INS_SITE_CONTACT===
+
===MD_INS_INS_SITE_CONTACT ===
 
[[MDCCD Data Warehouse|Return to Home Page.]]
 
[[MDCCD Data Warehouse|Return to Home Page.]]
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{| 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
 
|-
 
|-
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|}
 
|}
   −
===MD_INS_INS_LICENCE===
+
===MD_INS_INS_LICENCE ===
 
[[MDCCD Data Warehouse|Return to Home Page.]]
 
[[MDCCD Data Warehouse|Return to Home Page.]]
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{| 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
 
|-
 
|-
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|}
 
|}
   −
===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
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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
 
|-
 
|-
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