Calyx RIM Administration

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.
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 Nomenclature The nomenclature systems available to identify devices. The nomenclature system supports the description of the device.
Device Sterility Indicator Is used to specify whether the device is supplied as sterile using an appropriate controlled terminology.
Device Type The type of the device, for example Administration device, Integrated device, Medical device, Other device.
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.
Global Medical Device Nomenclature (GMDN) Code Values Global Medical Device Nomenclature (GMDN) Code is used to identify medical devices.
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.
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.

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 Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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 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 Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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 Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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.
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 Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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 Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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.
Code Name The full name and/or description for the code.
Last User Updated Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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 Nomenclature Attributes

To define a device allergenicity 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 Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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 Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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 Type Attributes

To define a device type 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 Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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 Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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.
Routes of Administration Routes of Administration associated with the dosage form.
RMS Term Name List of Active Dosage/Pharmaceutical Form RMS Values available for selection.
Last User Updated Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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.

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 Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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 Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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 Medical Device Nomenclature (GMDN) Code Attributes

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

Attribute Description
GMDN Code The name of the code.
GMDN Term Name Description of the GMDN Code. GMDN Code and Term Name must be unique within a system.
Last User Updated Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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 Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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.
RMS Term Name List of Active Medical Device RMS Values available for selection.
Last User Updated Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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 Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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 Enables you to 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 Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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 Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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 Active Route of Administration RMS Values available for selection.
Description Description field.
Last User Updated Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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 Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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 Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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.
Last User Updated Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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 Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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.

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 Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date Defines when the Data Administration value was created/updated. 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.