Argus Safety Database Notes Ch2, Slides of Computer science

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Business Configuration

This section explains the Business Configuration of the Argus Console,

categorized into the following modules:

Editable and Non-editable Business Configuration Sections

Each of the three Business Configuration sub-sections supports various views for

efficient access to data. Each view consists of a hierarchical tree-structure comprising

various nodes such as Family, Product, Licenses, and Countries.

The following table list which nodes can be edited and which cannot.

Configuring Product Family

Each company has a set of products to sell and a set of processes unique

to its business. The Administrator should be aware of the company

business processes and/or workflow rules. The manner of product

configuration in Argus Safety will depend on how the company handles

its internal workflow related to the release of a product.

Details of the company's products can be added in Argus Safety using the

Business configuration section. This feature helps end-users to retrieve

details of company products, without entering significant product

information for each case.

Every company product should belong to a product family. Each product

within a product family shares the same key ingredient and data sheets

but can have a different concentration for the key ingredient.

Configuration of the product is done using the Business Configuration-

>Products and Licenses section.

Adding Product Families:

The screen helps in capturing the Product Family information. As per

the Argus data model, the Product Family adds the Ingredients, Data

Sheets, and the Product group.

Products are associated with Product families and are created using the

Data Sheets, Dosage form, Strength and unit of the corresponding

Product Family.

The Product Group field in the Product Family configuration screen

enables the Argus administrator to group the product families into

various Product Groups.

To create product group, Go to codelist-> Argus->select product group-

>click add new-> fill the fields ->Save

To add a product family

1. In the Business Configuration section, select Product and Licenses.
2. In the left panel, select a filtering criterion. The left panel now displays

the tree view of the Family based on the filtering criterion.

1. Select a Product Family and click to view the product family details in

the right panel. Product family details appear in the right panel.

Tip:

■ You can alternatively click Add Family to create a new family of

products.

■ Use Copy to make an editable copy of an existing product family.

■ Use Copy with Datasheets to make an editable copy of an existing

product family, along with all associated datasheets.

Creating Data Sheets:

Packaged medications (like prescriptions) are marketed with an insert

sheet that lists the known contraindications (side-effects) that may occur

as a consequence of taking the product.

These inserts are also referred to as data sheets. It is important to list

these effects in order to ensure accuracy in reporting. An inaccurate

report could result in the wrong action taken or bring harm to a patient.

The Listed Event terms from the data sheet determine the listedness of

the adverse event(s) for the case. Depending on the configured regulatory

report rules, the listedness determination will automatically schedule the

expedited reports.

The data sheet in the Product Family is configured using the Business

Administration -> Products Family section.

To create a datasheet

1. In the Datasheet section of the Product Family section, click Activate

Datasheet to activate the data sheet associated with the Product Family.

1. Select the Core Sheet check box, if this data sheet is required to be the

core data sheet. Only one core data sheet is allowed per product. The

Core Sheet checkbox enables the user to indicate that this data sheet is

the central data sheet.

1. Select the Include check box and select the value from a drop-down

list. This helps you to indicate that this data sheet includes the particular

datasheet selected in the drop-down list.

1. Select Global/No local labeling assessment required to automatically

mark any license using this data sheet as assessed.

1. Click Add Term to select the listed terms (Preferred Term) for the

datasheet. The MedDRA browser appears.

Configuring Products

Each company has a set of products to sell and a set of processes that are

unique to its business.

The manner of product configuration in Argus Safety depends on how the

company handles its internal workflow, related to the release of a product.

Therefore the Administrator should be familiar with the business

processes or workflow rules of the company.

These can be the products marketed, or under investigation, by the

company. Every company product should belong to a product family.

Each product within a product family shares the same key ingredient and

data sheets but can have a different concentration for the key ingredient.

Configuration of the product is done in the Business Administration ->

Products and Licenses section.

To add a product

1. In the Business Configuration section, select Product and Licenses.
2. In the left panel, select a filtering criterion.
3. Select a Product and click to view the product details in the right panel.
4. The details of the product appear in the right panel as shown.

Tip:

■ You can alternatively click Add Product to create a new product.

■ Use Copy to make an editable copy of an existing product.

■ Use Copy with Licenses to make an editable copy of an existing

product, along with all associated licenses.

1. Enter the Product Name. The Product name must be at least five (5)

characters and Product Abbreviation.

1. Enter the Dose information associated with the Ingredient Names in

the Key Ingredients section.

1. Enter the Company Code allotted for the product.
2. Enter the Lot# and Date associated with the Product.
3. Click Save to save the Product details.

Note: International Birth Date field Displays the international birthdate,

which is automatically calculated from the earliest license, held against

this product. This field is read only.

Using Organized by

The filtering browser is displayed in the top-left corner of the left panel.

The Products and Licenses section can be filtered based on any of the

three combinations shown in the following illustration. Consider the

following:

■ If you enable Organized by Family/Product/License, then the

generated output will be visible in a tree-format in the left panel.

■ If you enable the Organized by Product/License, only the Product and

License views are available in the tree view in the left panel.

The Argus Console helps you to filter information further for the

Business Configuration section. Once you have selected the Organized

by, you can specify whether your search should contain or start with

specific alphabets.

To add a product license

In the Business Configuration section, select Product and Licenses.

In the left panel, select a filtering criterion.

Expand the folders till you reach the license associated with a product.

Select a license and click to view the license in the right panel.

Click Add new license to add the license.

Enter the Trade Name of the license under which this product(s) is (are)

authorized by this license.

Enter Award Date (the date the license was granted to the manufacturer)

and Withdrawn Date for this license. The withdrawn date cannot be less

than the award date.

In the Manufacturer list, select the manufacturer of the product.

Select the Authorization Country in which the license was issued. The

chosen country does not impact the reporting rules

Select the License Type. The user can select one of the possible six

types: Investigational Drug/Device/Vaccine or Marketed

Drug/Device/Vaccine.

Enter the license number in License#, which will be referred in the

regulatory reports like NDA, IND.

If this license is to be reported under the PLA# and not the NDA# select

the Biologic/Vaccine checkbox. If this checkbox is selected, the PLA#

(and not the NDA#) will be printed in section G5 of the MedWatch form.

Specify if the drug is Labeled for Single Use or not.

Specify if the drug has been bought as an Over-the-Counter (OTC)

Product.

Enter the Company item number corresponding to the license in

Company item number field.

Enter a URL reference for the license under Data Sheet URL (A URL

reference might be a link to product label or product information).

A world wide web address or an appropriate network path (For example:

http://anydomainname/anypath or \FILESERVER\LOCATION) can be

entered in this field.