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→MD_INS_CASE_OBSERVATIONS
! 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.]]
{| 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;" |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
|-
|-
|}
|}
===MD_INS_INS_IID===
===MD_INS_INS_IID ===
[[MDCCD Data Warehouse|Return to Home Page.]]
[[MDCCD Data Warehouse|Return to Home Page.]]
{| 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;" |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
|-
|-
|
|
|}
|}
===MD_INS_INS_INSPECTORLIST===
===MD_INS_INS_INSPECTORLIST ===
[[MDCCD Data Warehouse|Return to Home Page.]]
[[MDCCD Data Warehouse|Return to Home Page.]]
{| 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;" |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
|-
|-
|}
|}
===MD_INS_INS_IRC_ENFORCEMENT===
===MD_INS_INS_IRC_ENFORCEMENT ===
[[MDCCD Data Warehouse|Return to Home Page.]]
[[MDCCD Data Warehouse|Return to Home Page.]]
{| 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;" |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
|-
|-
|}
|}
===MD_INS_INS_IRC_MEASURES===
===MD_INS_INS_IRC_MEASURES ===
[[MDCCD Data Warehouse|Return to Home Page.]]
[[MDCCD Data Warehouse|Return to Home Page.]]
{| 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;" |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
|-
|-
|}
|}
=== MD_INS_INS_IRC_OBSERVATIONS===
===MD_INS_INS_IRC_OBSERVATIONS ===
[[MDCCD Data Warehouse|Return to Home Page.]]
[[MDCCD Data Warehouse|Return to Home Page.]]
{| 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;" |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
|-
|-
|}
|}
=== MD_INS_INS_SITE===
===MD_INS_INS_SITE ===
[[MDCCD Data Warehouse|Return to Home Page.]]
[[MDCCD Data Warehouse|Return to Home Page.]]
{| 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;" |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
|-
|-
|}
|}
===MD_INS_INS_SITE_CONTACT===
===MD_INS_INS_SITE_CONTACT ===
[[MDCCD Data Warehouse|Return to Home Page.]]
[[MDCCD Data Warehouse|Return to Home Page.]]
{| 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
|-
|-
|}
|}
===MD_INS_INS_LICENCE===
===MD_INS_INS_LICENCE ===
[[MDCCD Data Warehouse|Return to Home Page.]]
[[MDCCD Data Warehouse|Return to Home Page.]]
{| 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;" |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
|-
|-
|}
|}
===MD_INS_INS_SITELICENCEACTIVITY===
===MD_INS_INS_SITELICENCEACTIVITY ===
[[MDCCD Data Warehouse|Return to Home Page.]]
[[MDCCD Data Warehouse|Return to Home Page.]]
{| 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;" |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
|-
|-
