Calyx RIM for Registrations

Component Details in a PDS

You can track the details of a Product Detail Set for each component that was defined at the product level.

Note: You can also use the PDS to track flu strains as an Active Ingredient. You can assign only one flu strain for each active ingredient.
The entities in the chart under Component Details represent the cosmplete set of grouping nodes that may appear under a component parent node in a PDS tree. The component's entity type determines if any nodes are excluded:
  • Flu Vaccine, Pharmaceutical, or Veterinary entity type - Medical Devices node is excluded.
  • Medical device entity type - Active Ingredients and Substances nodes are excluded.
  • Pharmaceutical-medical device combination entity type - No nodes are excluded.

When you click a grouping node, the right pane provides links to InSight registration entities associated with the PDS, like product family, product, application, event, and any PDS details already associated with the grouping node.

Active Ingredients

For each component defined at the product level that is of the flu vaccine, pharmaceutical, veterinary, or pharmaceutical-medical device combination entity type, the PDS enables you to associate active ingredients with those components. You may associate none or several active ingredient entities with each component in a PDS. However, the active ingredients you can associate is limited to those associated at the product component level. After you associate an active ingredient with a component, you can associate information regarding the manufacturer or manufacturing process for the active ingredient.

Substances

There are two types of Substances - Excipients and Adjuvants. Excipients and Adjuvants are tracked at the PDS level for product components of the pharmaceutical, veterinary, or pharmaceutical-medical device combination entity type. You may associate zero or more excipient entities with each component in the PDS. The substances that you may choose from when associating an excipient and an adjuvant are pre-defined by your InSight system administrator. When associating an excipient to a component, you define the role that the substance serves in the delivery of the component. Since an excipient may serve multiple roles, the same excipient substance may be associated multiple times with a component in different roles.

Component Manufacturing Details

Manufacturing details related to product components are tracked at the PDS level. Manufacturing details are categorized in the tree as the manufacturing processes and functions performed to produce a component. You may associate zero or more processes and functions to a component, and you can "drill down" to specify more granular details about the steps, materials and manufacturers related to the processes and functions.

Medical Devices

For each component defined at the product level that is of the medical device or pharmaceutical-medical device combination entity type, the PDS allows you to associate medical device details with those components. You may associate zero or more medical device detail entities with each component in a PDS.

Characteristics

The characteristic PDS detail allows you to capture information that describes a component. Using predefined attributes and a free-form text, you can track features of a component, such as color and shape, in the characteristic PDS detail. You may associate only one characteristic detail entity per component in a PDS.