Siebel Life Sciences Guide > Capturing Adverse Events and Complaints > Process of Capturing and Escalating Adverse Events and Complaints >
Setting Up Codes
This task is a step in Process of Capturing and Escalating Adverse Events and Complaints. Codes allow you to codify many aspects of the AECM process. For example, codes are used to categorize the service request that triggers the adverse event or complaint, and codes are used to categorize the corrective actions initiated at the end of a complaint's life cycle. Multiple codes and sometimes codes of multiple types can be specified in one code field. Think carefully when designing and setting up your code system. Codes are used as search criteria for service requests and product issues. According to your business needs, you can use:
- Industry codes such as FDA patient, device, method, results, and conclusion codes required for the MedWatch 3500A form
- Company-specific codes
- A combination of industry and company-specific codes
Table 31 lists where code fields appear in the Siebel AECM module.
Table 31. Code Fields in the Siebel AECM Module
|
|
|
|
Service Requests |
More Info |
Codes |
None. |
Product Issues |
More Info |
Codes |
Copied from the service request when a product issue is created. Codes from the service request record are copied to this field when a product issue is created from a service request. |
Product Issues |
Corrective Actions |
Codes |
Typically, codes of type Corrective Action are entered in this field, although any type of code can be entered. |
Product Issues |
Investigation |
Method Codes |
Only codes of type Method can be entered. |
Product Issues |
Investigation |
Result Codes |
Only codes of type Result can be entered. |
Product Issues |
Investigation |
Conclusion Codes |
Only codes of type Conclusion can be entered. |
Product Issues |
Investigation |
Non-Evaluation Codes |
Only codes of type Non-Evaluation can be entered. |
Product Issues |
Importer MDV |
Patient Codes |
Only codes of type Patient can be entered. |
Product Issues |
Device Codes |
Only codes of type Device can be entered. |
Repairs |
More Info |
Codes |
Typically, codes of type Product Analysis are entered in this field, although any type of code can be entered. |
Corrective Actions |
More Info |
Codes |
Typically, codes of type Corrective Action are entered in this field, although any type of code can be entered. |
Regulatory Reports |
More Info |
Method Codes |
Only codes of type Method can be entered. Copied from the product issue when a regulatory report is populated. |
Regulatory Reports |
More Info |
Result Codes |
Only codes of type Result can be entered. Copied from the product issue when a regulatory report is populated. |
Regulatory Reports |
More Info |
Conclusion Codes |
Only codes of type Conclusion can be entered. Copied from the product issue when a regulatory report is populated. |
Regulatory Reports |
More Info |
Non-Evaluation Codes |
Only codes of type Non-Evaluation can be entered. Copied from the product issue when a regulatory report is populated. |
Regulatory Reports |
Importer MDV |
Patient Codes |
Only codes of type Patient can be entered. Copied from the product issue when a regulatory report is populated. |
Regulatory Reports |
Importer MDV |
Device Codes |
Only codes of type Device can be entered. Copied from the product issue when a regulatory report is populated. |
Activities |
Items |
Code |
Single value field. |
An Example
When you set up codes, you can enter values for Product, Product Line, Category, Type, Area, and Sub Area that are associated with the code. Call center agents can use these values to search for and identify the correct code for a service request. Table 32 is an example of the field values used to describe one code.
Table 32. Example Fields for a Code Classifying a Pump Error on a Blood Analyzer
|
|
Name |
Error 333 |
Description |
Blood analyzer pump overflow. |
Code Type |
Device |
Product |
Blood Analyzer Model 350, Blood Analyzer Model 373. This field can have multiple values. |
Product Line |
Blood analyzer, Dialysis system This field can have multiple values. |
Category |
Nephrology |
Type |
Potential Complaint |
Area |
Software |
Sub Area |
Pump timing |
How to Set Up Codes
Create the codes needed to classify your company's adverse events and complaints. Codes are needed for the procedures in this chapter and for procedures in the following AECM chapters. To set up codes
- Navigate to Administration - Service screen, then the Code Administration view.
- In the Code Admin list, create a new record and complete the necessary fields.
Some fields are described in the following table.
|
|
Name |
Enter the name for the code. Typically this is a number or a letter number combination. |
Code Type |
Examples are: Method, Result, Conclusion, Device, Patient. |
Product |
Multiple products can be associated with a code. |
Product Line |
Multiple product lines can be associated with a code. |
Category |
A grouping of products. Only one category can be associated to a code. To set up categories, see Siebel Order Management Guide. |
Type |
Use to categorize the type of service request, for example, as a potential complaint. This is the same LOV used in service request and product issue records. |
Area |
The Type field constrains this drop-down list. |
Sub Area |
The Area field constrains this drop-down list. |
|