OpenText™ Documentum™ for Quality and

Configuration Requirements Specification

Section 3: Data Model Relationships

180
or Quality and Manufacturing 16.4
cification
This documentation has been created for software version 16.4.

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Configuration Requirements Specification LS QM 4.0
Section 3 Data Model Relationship
Version Date Revised By Comments
1.0 15-Jun-2015 Jessica Kelley Initial publication.

Version: 1.0
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Issue Date: June 2015
Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties

The following assumptions apply to this document:

1 Each tab in this spreadsheet describes a tab that should appear for a Registration Form as described in the Notes on the tab
2 The name of the tab on the property screen will be the same as the tab on the spreadsheet.
3 The order of the attributes on the tabs are as they should appear in the system.
4 Cells that are left blank imply a value of "No" or not applicable value. They are left blank to improve readability.
5 Naming conventions for Registration Form are described on the Tab Assignments tab
6 The following chart defines the symbols used on the tabs to describe characteristic of properties

Required property R
Optional property O
System populated S
Do not fill if blank

Notes
Updating header/footer for all worksheets in the file at once
Select a tab by right-clicking on it and choose Select All Sheets
Next, click on View -> Header and Footer
Changes made will apply to all sheets in the file.
Make sure to deselect all sheets prior to making any other changes to the document!!

Creating the workbook as a PDF file

Select File -> Print
Under Printer > Name select Adobe PDF
Under Print What select Entire Workbook
The Save PDF File As window will appear. Navigate to the folder you want to save the file to and type a name for the file.
Click on Save. The Adobe Acrobat application will open with the file you just created.

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Configuration Requirements Specification LS QM 4.0
Section 3 Data Model Relationship

Registration Form Applicable Tabs

Medical Device Registration Form
Device Info (Device Info)

Access Control Device (Access Control Device)

Vaishnavi P B:
LSCI-16943
Default Users / Groups Device (Default Users / Groups
Medical Device)
Device
Form Info (Form Info) - Edit Only Registration Form
help text is incorrect
Medical Device Regulatory-Admin Registration Form

Regulatory Application Info (Regulatory Application Info)

Access Control (Access Control)

Default Users / Groups (Default Users / Groups)

Form Info (Form Info) - Edit Only

Medical Device Submission Registration Form

Submission Info (Submission Info) - Create Only

Submission Info (Submission Info) - Edit Only

Application Info (Application Info) - (Edit Only

Access Control (Access Control) - Edit Only

Manufacturing Item Registration Form

Item Info
Active Ingredient
Semi-finished Goods
Access Control

Product Registration Form

Product Info (Product Info)

Access Control Product (Access Control)

Form Info (Form Info) - Edit only

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Configuration Requirements Specification LS QM 4.0
Section 3 Data Model Relationship

Registration Form Naming Convention

<device family> - <device subfamily>

Vaishnavi P B:
LSCI-16943
Medical Device
Registration Form
help text is incorrect
<application_description>

<application_num> - <submission_number> - <submission_type>

<item_name>

<product_code>

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Configuration Requirements Specification LS QM 4.0
Section 3 Data Model Relationship

Property Page Name

Medical Device Registration Form Properties
Medical Device Update Device Information Properties

Medical Device Regulatory-Admin Registration Form Properties

Medical Device Submission Registration Form Properties (new)

Medical Device Registered Submission Registration Form Properties (edit)

Manufactured Item Registration Form Properties

Product Registration Form Properties

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Configuration Requirements Specification LS QM 4.0
Section 3 Data Model Relationship

Registration Form Auto Link Paths

/MD Registration Forms/Medical Devices Library

/MD Registration Forms/Regulatory Application Library/$value(region.Geographic Regions.en)

/MD Registration Forms/Regulatory Application Library/$value(region.Geographic Regions.en)/Submissions

/MD Registration Forms/Regulatory Application Library/$value(region.Geographic Regions.en)/Submissions

/Manufactured Items Library/Active Ingredients/$value(applicable_sites)/$value(item_name.Manufacturing Item first letter.first_letter)

/Manufactured Items Library/Finished Goods/$value(applicable_sites)/$value(item_name.Manufacturing Item first letter.first_letter)
/Manufactured Items Library/Semi-Finished Goods/$value(applicable_sites)/$value(item_name.Manufacturing Item first letter.first_letter)

/Product Library

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Property Name Inherited From

dv_device_family cd_common_ref_model
dv_device_subfamily cd_common_ref_model
dv_device_code cd_common_ref_model
dv_device_name cd_common_ref_model

dv_device_model_number cd_common_ref_model
product_trade_name cd_common_ref_model
product_trade_country cd_common_ref_model

<comment>
Property Label Description Data Type

Device Family STRING 120

Device Subfamily STRING 120
Device Code STRING 64
Device Name STRING 64

Device Model Number STRING 64

Device Trade Name(s) STRING 128
Device Trade Country STRING 2

This information will be copied automatically to

documents related to this medical device when
they are created.
Repeating Field Type DQL Query Load Default Value
Asynch

No Text
No Text
Yes1 Text
Yes1 Text

Yes1 Text
Yes1 Text
Yes1 Combo
Applicable Attribute Visibility Conditions Enabled Condition
Dictionary Dependence

New and Edit New

New and Edit New
New and Edit New and Edit
New and Edit New and Edit

New and Edit New and Edit

New and Edit New and Edit
Submission Country New and Edit New and Edit
Required/Optional/
System Generated

R
R
R

O
O

O
Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
Property Name Inherited From Property Label Description Data Type Repeating Field Type

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
DQL Query Load Default Value Applicable Attribute Visibility Enabled Condition
Asynch Dictionary Dependence Conditions

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
Required/Optional/
System Generated

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
Property Name Inherited From Property Label Description Data Type Repeating Field Type

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
DQL Query Load Default Value Applicable Attribute Visibility Enabled Condition
Asynch Dictionary Dependence Conditions

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
Required/Optional/
System Generated

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
Property Name Inherited From Property Label Description Data Type Repeating Field Type

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
DQL Query Load Default Value Applicable Attribute Visibility Enabled Condition
Asynch Dictionary Dependence Conditions

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
Required/Optional/
System Generated

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Property Name Inherited From Property Label

form_managers cd_controlled_doc Form Managers

<Comment> These users will be responsible for managing

the Manufactured Item information and
Default Role settings in this form.

separator
form_users cd_controlled_doc Primary User Group(s)

<Comment> These users will be able to read this form and

create documents related to this
Manufactured Item.
Description Data Type Repeating Field Type

STRING 255 Yes List

Label

STRING 255 Yes List

Label
DQL Query Load
Asynch

select groups_names from dm_group where any 1

i_supergroups_names =
'cd_gmp_item_registration_group' union select
users_names from dm_group where any
i_supergroups_names =
'cd_gmp_item_registration_group' union select
group_name from dm_group where group_name =
'cd_gmp_item_registration_group'

select groups_names from dm_group where any TRUE

i_supergroups_names IN ('cd_gmp_all_users') union
select users_names from dm_group where any
i_supergroups_names IN ('cd_gmp_all_users') union
select group_name from dm_group where
group_name IN ('cd_gmp_all_users')
Default Value Applicable Attribute Visibility
Dictionary Dependence Conditions

<current user> New, Edit,

Import

New, Edit,
Import

New, Edit,
Import

New, Edit,
Import
Enabled Condition Required/Optional/
System Generated

New, Edit, Import

NA

New, Edit, Import

NA
Property Name Inherited From Property Label Description

api_item_codes cd_manu_item_info Active Ingredient Codes Active Ingredients used

in 'Finished Good' or
'Semi-finished Good'
item.

api_item_names cd_manu_item_info Active Ingredient Description of

Names associated Active
Ingredient.

Note:
Visible if Item Type is 'Finished Good' or 'Semi-finished Good'.
Read only if there is any document associated with the registration form.
Data Type Repeating Field Type

STRING 32 Yes Combo

STRING 255 Yes Combo

DQL Query Load Asynch Default Value

select item_code from cd_manuf_item_info

where item_code != '$value(item_code)' and
item_type = 'Active Ingredient' and a_status =
'Active' order by 1

select item_name from cd_manuf_item_info

where item_code = '$value(api_item_codes)'
order by 1
Applicable Dictionary Attribute Dependence Visibility Conditions Enabled Condition

New and Edit New and Edit

New and Edit

Required/Optional/
System Generated

O
Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
Property Name Inherited From Property Label Description Data Type Repeating Field Type

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
DQL Query Load Default Value Applicable Attribute Visibility Enabled Condition Required/Optional/
Asynch Dictionary Dependence Conditions System Generated

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
Property Name Inherited From Property Label Description Data Type Repeating Field Type

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
DQL Query Load Default Value Applicable Attribute Visibility Enabled Condition Required/Optional/
Asynch Dictionary Dependence Conditions System Generated

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
Property Name Inherited From Property Label Description Data Type Repeating Field Type

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
DQL Query Load Default Value Applicable Attribute Visibility Enabled Condition Required/Optional/
Asynch Dictionary Dependence Conditions System Generated

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Property Name Inherited From Property Label

item_code cd_quality_gmp Item Code

item_type cd_quality_gmp Item Type

product_code cd_common_ref_model R&D Product Code (where applicable)

item_name cd_quality_gmp Item Name

applicable_sites cd_quality_gmp Applicable Sites

a_status dm_sysobject Status
r_modifier dm_sysobject Modify By
r_modify_date dm_sysobject Modified
a_application_type dm_sysobject Application Type
reference_count*

Note:
Read only if there is any document associated with the registration form.
* This field is not linked to any property and is used as a control id.
Description Data Type Repeating

Unique item ID of the STRING 32 No

Manufactured Item Registration
Form.

Type of the Manufactured Item STRING 32 No

Registration Form.
Product associated with STRING 32 No
Manufactured Item Registration
Form.

Description of the Manufactured STRING 255 No

Item Registration Form.

Applicable Sites STRING 255 Yes

Status of Registration form. STRING 16 No
STRING 255 No
Date No
STRING 32 No
Contains the number of
documents associated with
registration form. Used to decide
the editability of tabs.
Field Type DQL Query Load Asynch

Text

Combo

Combo select distinct product_code from

cd_product_info where a_status = 'Active' and
product_code != ' '

Editable Combo select distinct drug_substance_name from

cd_product_info where '$value(item_type)' =
'Active Ingredient' and product_code =
'$value(product_code)' union select distinct
product_generic_name from cd_product_info
where '$value(item_type)' != 'Active Ingredient'
and product_code = '$value(product_code)'
union select distinct product_trade_name from
cd_product_info where '$value(item_type)' !=
'Active Ingredient' and product_code =
'$value(product_code)' order by 1

Editable List
Text
Text
Text
Text
select count(*) from
dm_dbo.cdv_quality_gmp_item_code_refs
where item_code = '$value(item_code)' and
r_object_id != '$value(r_object_id)' and
a_status not in ('Withdrawn', 'Inactive') AND
NOT EXISTS (select r_object_id from
cd_manuf_item_info where
item_code='$value(item_code)' and
r_object_id!='$value(r_object_id)')
Default Value Applicable Dictionary Attribute Dependence Visibility Conditions

New and Edit

GMP Manufactured New and Edit

Item Type
New and Edit

New and Edit

GMP Applicable Sites New and Edit

Edit
Edit
Edit
LSQM-D2
Enabled Condition Required/Optional/
System Generated

New and Edit

O/S

New and Edit

R
New and Edit
O

New and Edit

New and Edit R

S
S
S
S
Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
Property Name Inherited From Property Label Description Data Type Repeating Field Type

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
DQL Query Load Default Value Applicable Dictionary Attribute Dependence Visibility Enabled Condition Required/Optional/
Asynch Conditions System Generated

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
Property Name Inherited From Property Label Description Data Type Repeating Field Type

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
DQL Query Load Default Value Applicable Dictionary Attribute Dependence Visibility Enabled Condition Required/Optional/
Asynch Conditions System Generated

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
Property Name Inherited From Property Label Description Data Type Repeating Field Type

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
DQL Query Load Default Value Applicable Dictionary Attribute Dependence Visibility Enabled Condition Required/Optional/
Asynch Conditions System Generated

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
Property Name Inherited From Property Label Description Data Type Repeating Field Type

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
DQL Query Load Default Value Applicable Dictionary Attribute Dependence Visibility Enabled Condition Required/Optional/
Asynch Conditions System Generated

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Property Name Inherited From Property Label Description

sfg_item_codes cd_manu_item_info Semi-Finished Goods Semi-finsihed Goods

Item Codes used in 'Finished Good'
or 'Semi-finished Good'
item.

sfg_item_names cd_manu_item_info Semi-Finished Goods Description of

Item Names associated Semi-
finsihed Goods.

Note:
Visible if Item Type is 'Finished Good' or 'Semi-finished Good'.
Read only if there is any document associated with the registration form.
Data Type Repeating Field Type

STRING 32 Yes Combo

STRING 255 Yes Combo

DQL Query Load Asynch Default Value

select item_code from cd_manuf_item_info

where item_code != '$value(item_code)' and
item_type = 'Semi-finished Good' and a_status
= 'Active' order by 1

select item_name from cd_manuf_item_info

where item_code = '$value(sfg_item_codes)'
Applicable Dictionary Attribute Dependence Visibility Conditions Enabled Condition

New and Edit New and Edit

New and Edit

Required/Optional/
System Generated

O
Property Name Inherited From

dv_device_family cd_common_ref_model

dv_device_subfamily cd_common_ref_model

dv_device_code cd_common_ref_model

dv_device_name cd_common_ref_model

dv_device_model_number cd_common_ref_model
product_trade_name cd_common_ref_model
product_trade_country cd_common_ref_model

<comment>
Property Label Description Data Type

Device Family STRING 120

Device Subfamily STRING 120

Device Code STRING 64

Device Name STRING 64

Device Model Number STRING 64

Device Trade Name(s) STRING 128
Device Trade Country STRING 2

This information will be copied automatically to

documents related to this medical device.
Repeating Field Type DQL Query Load Default Value
Asynch

No Combo SELECT DISTINCT dv_device_family FROM TRUE

cd_product_info WHERE a_status != 'Inactive'
AND dv_device_family != ' ' ORDER BY 1

No Combo SELECT DISTINCT dv_device_subfamily FROM TRUE

cd_product_info WHERE a_status != 'Inactive'
AND dv_device_family =
'$value(dv_device_family)' AND
dv_device_subfamily != ' ' ORDER BY 1

Yes1 Text SELECT DISTINCT dv_device_code FROM

cd_product_info WHERE a_status != 'Inactive'
AND dv_device_family =
'$value(dv_device_family)' AND
dv_device_subfamily =
'$value(dv_device_subfamily)' AND ANY
dv_device_code != ' ' ORDER BY 1

Yes1 Text

Yes1 Text
Yes1 Text
Yes1 Combo
Applicable Attribute Visibility Conditions Enabled Condition
Dictionary Dependence

New and Edit

New and Edit

New and Edit New and Edit

New and Edit New and Edit

New and Edit New and Edit

New and Edit New and Edit
Submission Country New and Edit New and Edit
Required/Optional/
System Generated

O
O

O
Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties

Product Info Properties Definition

Inherited From Property Label Description Data Type Repeating Field Type DQL Query Load Asynch

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties

Default Applicable Attribute Visibility Enabled Required/Optional/

Value Dictionary Dependence Conditions Condition System Generated

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
Property Name Inherited From Property Label Description Data Type Repeating Field Type

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Configuration Requirement Specification DCTM Q 3.1
Appendix B Document Properties
DQL Query Load Default Value Applicable Attribute Visibility Enabled Condition Required/Optional/
Asynch Dictionary Dependence Conditions System Generated

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