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

The following table outlines where code fields appear in the Siebel AECM module.

Screen	View	Field Name	Notes
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.