Product Maintenance

Product maintenance values appear in lists on the Product Attributes page and are designated when a product is created. Data Administration enables you to add and modify list values, and set the status of a value to active or inactive.

When you select a value under Product Maintenance, a table of all values that have been defined appears. You can sort these values by column. The default view is sorted in ascending, alphanumeric order.

Note: The proper Data Administration access privileges are required to view and modify application maintenance values.

All XEVMPD Data Administration tables provide the ability to configure extra fields. The standard set consists of twenty extra text fields, five extra date fields, and five extra number fields.

Product Maintenance: Product Values

You can create and maintain the following product values:


Value	Description
Applicable Standards	Standards to which a medical device must adhere (values are codes). Typically referenced in the essential requirements checklist of the technical file and are printed on the Declaration of Conformity. EU-specific.
Conformity Assessment Body	An agency, organization, or company, which may include a third party or a supplier's testing laboratory, or a certification body, that performs conformity assessment or testing to an importing Party's Technical Regulations.


Value	Description
Conformity Assessment Path	Paths taken for conformity assessment as identified in the EU MDD (Medical Device Directive) - Annex II, III, IV, V, VI, VII and in combination. The EU rules and regulations to which a medical device must adhere. EU only.
Country Specific Detail Type	The type of details specific to a country.
Country Specific Detail Value	The detail value specific to a country.
Device Allergenicity	The Device Allergenicity is used to specify whether the device contains allergens and/or materials of concern.
Device Sterility Indicator	Is used to specify whether the device is supplied as sterile using an appropriate controlled terminology.
Device Usage	Specifies the number of times that the device may be used as described in the regulated product information.
Dosage/Pharmaceutical Form	Pharmaceutical product in the form in which it is marketed for use, typically involving a mixture of active drug components and non-drug components (excipients), along with other non-reusable material that may not be considered either ingredient or packaging. Can be defined at the product level, at the individual component level, or at both levels. The list contains the pharmaceutical dose form values from the EMA Pharmaceutical Forms CV. The default value is set to Active. The standard set of extra fields can be configured for this value.
EC Cert	Design certification for Class III products.
EU Classification Rule	Rules 1 through 18, Rule 99.
EU Class	Classes of increasing risk to a patient according to the device properties, function and intended purpose as defined by the MDD for medical devices.
FDA Device Class	FDA classification based on risk.
Global Harmonization Task Force (GHTF) Class	Class as defined by the GHTF with values 1, 2, or 3.
Manufacturing Location	Where a device component can be manufactured. Defined at the product level, the individual component level, or both.
Medical Device	Defines a category of devices based on the level of control necessary to assure the safety and effectiveness of the device. The list contains medical device values and medical device code from the EMA Medical Device CV. The standard set of extra fields can be configured for this value.
Value	Description
Product Characteristics	Can be used to describe various characteristics of the pharmaceutical product. It can be defined to complete the definition of a product using variants. Product Characteristics are attributes that can be added to the product definition to extend the description of each product.
Product Status	Current status of a product. Product statuses can be mapped to internal system statuses for the purpose of event-product associations.
Product Strength Unit	Abbreviated measurement name of the product strength, such as: mg/g, ml, g, or % w/v
Route of Administration	Defines how a product is introduced into the system, such as oral or intravenous. Dependent on dosage form. Can be defined at the product level, the individual component level, or both. The default value is set to Active. The standard set of extra fields can be configured for this value.
Special Measure	If the medicinal product is subject to specific special measures, these can be specified using an appropriate controlled vocabulary.
Sterilization	For example: none, ETO, radiation, or steam. For devices made of many components, each can be separately sterilized.
Sterilization Requirement	Where applicable, this can be used to specify whether the device shall be sterilized before use based on an appropriate controlled terminology.
Summary of Technical Documentation (STED)	Client-specific Summary of Technical Documentation IDs.
UMDNS Code Values	The nomenclature and coding system used for identifying, processing, retrieving, transferring, and communicating data about medical devices.
Product Category Type	The classification of the medicinal products.
Product Cross Reference Type	The type of medicinal product (MP) that is referenced. You can define it using a term ID.

Applicable Standards Attributes To define an applicable standard value, enter values for the following attributes:


Attribute	Description
Applicable Standards	Standards to which the device adheres (values are codes).
Version of Standard	Version of the applicable standard.
Last User Updated	Indicates the name of the user who last created/updated the applicable standards. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Attribute	Description
Active	Indicates if the entity is active or inactive.

Conformity Assessment Body Attributes

To define a conformity assessment body value, enter values for the following attributes:


Attribute	Description
Conformity Assessment Body Name	The name of the conformity assessment body (also know as Notified Body in EU).
Last User Updated	Indicates the name of the user who last created/updated the conformity assessment body. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Conformity Assessment Path Attributes

To define a conformity assessment body path value, enter values for the following attributes:


Attribute	Description
Conformity Assessment Path Name	Path taken for conformity assessment - Annex II, III, IV, V, VI, VII and in combination.
Last User Updated	Indicates the name of the user who last created/updated the country specific detail conformity assessment path. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Country Specific Detail Type Attributes

To define a country specific detail type value, enter values for the following attributes:


Attribute	Description
Country Specific Detail Type Name	The name of the country specific detail type.
Attribute	Description
Field Value Control	Field Value Control. Allowed HARDCODED values for Selection: Controlled-Single Value (default selection),Controlled-Multiple Values, User Entered.
	*Note:* The controlled field value for a Country Specific Detail type is locked post creation of Country Specific Detail values/Link up with Product.

Last User Updated	Indicates the name of the user who last created/updated the country specific detail. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Country Specific Detail Attributes

To define a country specific detail value, enter values for the following attributes:


Attribute	Description
Country Specific Detail Type	All active values of Country Specific Detail Types.
Countries	All active Countries values.
Country Specific Value	Value defined for the detail type when Field Value Control is "Controlled" in Country Specific detail Type. Field is hidden when Field Value Control is "User Entered". Country Specific Detail Value must be unique within Country Specific Detail Type.
Last User Updated	Indicates the name of the user who last created/updated the country specific detail. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Device Allergenicity Attributes

To define a device allergenicity value, enter values for the following attributes:


Attribute	Description
Code Value	The actual value for the code.
Attribute	Description
Code Name	The full name and/or description for the code.
Last User Updated	Indicates the name of the user who last created/updated the device allergenicity. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Device Sterility Indicator Attributes

To define a device sterility indicator value, enter values for the following attributes:


Attribute	Description
Code Value	The actual value for the code.
Code Name	The full name and/or description for the code.
Last User Updated	Indicates the name of the user who last created/updated the device sterility indicator. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Device Usage Attributes

To define a device usage value, enter values for the following attributes:


Attribute	Description
Code Value	The actual value for the code.
Code Name	The full name and/or description for the code.
Last User Updated	Indicates the name of the user who last created/updated the device usage. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Dosage/Pharmaceutical Form Attributes

To define a dosage/pharmaceutical form value, enter values for the following attributes:


Attribute	Description
Dosage Form (Long Name)	Full Dosage Form Name. Example: Capsule.
Dosage Form (Short Name)	Abbreviation for Dosage Form. Example: CAP.
FDA Code	FDA Code.
Type Term	Type of Dosage Form Term. Values available for selection are: — Development Term — Proposed Term — Standard Term
Version Date	The date of the last update of the administration route.
Description	A solid dosage form in which the drug is enclosed within either a hard or soft soluable container or shell made from a suitable form of gelatin.
Route of Administration	Routes of Administration associated with the dosage form.
Term ID	Term identifier of the Combined Pharmaceutical Dose Form.
Term Name	Name of the term to which the Combined Pharmaceutical Dose Form belongs.
Description	Description of the Combined Pharmaceutical Dose Form.
Last User Updated	Indicates the name of the user who last created/updated the dosage/ pharmaceutical form. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Flag	Indicates if the entity is active or inactive.
Active	Indicates if the entity is active or inactive.

EC Cert Attributes

To define a EC Cert value, enter values for the following attributes:


Attribute	Description
EC Cert	Design certs for class III products. Hyperlinked from the view screen.
Last User Updated	Indicates the name of the user who last created/updated the EC Cert value. By default, this option is read-only. It is populated automatically when updates were made to the table.
Attribute	Description
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Global Harmonization Task Force (GHTF) Class Attributes

To define a GHTF class value, enter values for the following attributes:


Attribute	Description
GHTF Class	Class as defined by the GHTF.
Last User Updated	Indicates the name of the user who last created/updated the Global Harmonization Task Force (GHTF) class. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Manufacturing Location Attributes

To define a manufacturing location value, enter values for the following attributes:


Attribute	Description
Manufacturing Location	Locations of the Device Manufacturers (assuming no PDS).
Last User Updated	Indicates the name of the user who last created/updated the manufacturing location. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Medical Device Attributes

To define a medical device value, enter values for the following attributes:


Attribute	Description
Medical Device Name	Medical Device Name value.
Medical Device Code	Medical Device Code for the Medical Device name. When a medical device is part of a product the Medical Device Code is required for XEVMPD.
Attribute	Description
RMS Term Name	List of Medical Device RMS Values available for selection.
Last User Updated	Indicates the name of the user who last created/updated the medical device. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Product Characteristics Attributes

To define a product characteristics value, enter values for the following attributes:


Attribute	Description
Code Value	Medical Device Name value.
Code Name	The full name and/or description for the code.
Last User Updated	Indicates the name of the user who last created/updated the product characteristics. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Product Status Attributes

To define a product status value, enter values for the following attributes:


Attribute	Description
Name	The name given for the Product Status.
Default Flag	Flag to indicate if the product status is the default.Yes and No values are available for selection.
System Process Default Flag	Select which of the added statuses will show for a Product status after the Event is closed.
Internal System Status	The internal status associated to the product status.
Last User Updated	Indicates the name of the user who last created/updated the product status. By default, this option is read-only. It is populated automatically when updates were made to the table.
Attribute	Description
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Product Strength Unit Attributes

To define a product strength unit value, enter values for the following attributes:


Attribute	Description
Product Strength Unit	Short Version of the Unit Measure name of the Product Strength.
Product Strength Unit Name	Long Version of the Unit Measure name of the Product Strength.
Last User Updated	Indicates the name of the user who last created/updated the product strength unit. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Route of Administration Attributes

To define a route of administration value, enter values for the following attributes:


Attribute	Description
Route of Administration (Long Name)	Full Route of Administration Name. Example: Oral.
Route of Administration (Short Name)	Abbreviation Route of Administration. Example: OR.
FDA Code	The list of FDA codes available for selection.
Type Term	Type of Route of Administration Term. Examples: 1 -Development Term, 2 - Proposed Term, 3 - Standard Term.
Version Date	The date of the last update of the administration route should be specified.
RMS Term Name	List of Route of Administration RMS Values available for selection.
Description	Description field.
Last User Updated	Indicates the name of the user who last created/updated the route of administration. By default, this option is read-only. It is populated automatically when updates were made to the table.
Attribute	Description
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Special Measure Attributes

To define a special measure value, enter values for the following attributes:


Attribute	Description
Code Value	The actual value for the code.
Code Name	The full name and/or description for the code.
Last User Updated	Indicates the name of the user who last created/updated the special measure. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Sterilization Requirement Attributes

To define a sterilization requirement value, enter values for the following attributes:


Attribute	Description
Code Value	The actual value for the code.
Code Name	The full name and/or description for the code.
Last User Updated	Indicates the name of the user who last created/updated the sterilization requirement. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Sterilization Attributes

To define a sterilization value, enter values for the following attributes:


Attribute	Description
Sterilization	Sterilization value. Examples: Values of none, ETO, Radiation, Steam.
Attribute	Description
Last User Updated	Indicates the name of the user who last created/updated the sterilization. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Summary of Technical Documentation (STED) Attributes

To define a summary of technical documentation value, enter values for the following attributes:


Attribute	Description
Summary of Technical Documentation	(STED) Client specific Summary of Technical Documentation Id's.
Last User Updated	Indicates the name of the user who last created/updated the summary of technical documentation (STED). By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

UMDNS Code Attributes

To define a UMDNS code value, enter values for the following attributes:


Attribute	Description
UMDNS Code	The name of the code.
UMDNS Description	Description of the UMDNS Code.
Last User Updated	Indicates the name of the user who last created/updated the UMDNS code. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Product Category Type Attributes

To define a product category value, enter values for the following attributes:


Attribute	Description
Product Category Type Name	The name of the product category.
Last User Updated	Indicates the name of the user who last created/updated the product category. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Product Cross Reference Type Attributes

To define a product cross reference type value, enter values for the following attributes:


Attribute	Description
Product Cross Reference Type Name	The name of the product that is referenced.
Last User Updated	Indicates the name of the user who last created/updated the product cross reference type. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.