Adverse Event

An adverse event is a customer event associated with a product malfunction or adverse reaction to a pharmaceutical. It can be initially captured as a service request and then escalated to a product issue (which becomes the complaint file associated with the event).

In some places in this text, complaints includes both adverse events and complaints.

AECM

Adverse Events and Complaints Management

Call Center Agent

Another name for this job title is customer service agent. This agent is trained to identify a product complaint and distinguish it from a normal service or information request.

CAPA

Corrective and preventive action. This specifies the changes in product or process needed to resolve the root cause of the adverse event or complaint. For example, a CAPA could be a request from the analysis team for the correction of the manufacturing, design, or process flaw that caused the initial adverse event or complaint.

Complaint

A complaint is a customer event associated with a product malfunction. It can be initially captured as a service request and then escalated to a product issue (which becomes the complaint file associated with the event).

In some places in this text, complaints includes both adverse events and complaints.

Initial regulatory report

The first report to a regulatory agency regarding a product complaint or an adverse event.

MDR

Medical device reports are required to be submitted to a regulatory agency when an adverse event or complaint is determined to be reportable.

MDV

Medical Device Vigilance

Medical Product

Examples of medical products are capital equipment, disposables, reagents, implanted devices, and pharmaceuticals.

MedWatch 3500A

U.S. Food and Drug Administration (FDA) report for mandatory reporting of adverse reactions and medical product problems by drug and biologic manufacturers and packers and by medical device manufacturers, distributors, importers, and user-facilities.

MedWatch 3500A Supplemental

A 3500A report sent as a follow-up to an initial 3500A report.

NCA

National Competent Authorities. Regulatory reports are often sent to these agencies. These country-specific agencies also report adverse events to each other.

Product Issue

A product issue is the adverse event or complaint file. The product issue is often first captured as a service request record. Then the information is transferred to a product issue record, which becomes the adverse event or complaint file.

Product Issue Assessments

A product issue assessment evaluates a product issue on defined criteria. For example, a product issue assessment can be used to determine whether the product issue should be reported to a regulatory agency.

Quality Manager

Other names for this job title are complaint investigator, regulatory affairs representative, safety and regulator manager, regulatory liaison, and quality group liaison.

Regulatory report

There are four types of regulatory reports supported by Siebel AECM (preconfigured):

• MedWatch 3500A
• MedWatch 3500A Supplemental
• MDV Initial
• MDV Follow-up

Regulatory report record. The record in the Regulatory reports screen.

Regulatory report. The Actuate report created using data contained in the regulatory report record.

Other regulatory reports like CIOMS can be configured using Actuate Report designer or other reporting tools.

Siebel AECM

The Siebel Adverse Events and Complaints Management module.

Signature capture

See User authentication.

SmartScripts

A SmartScript is a collection of predefined questions, answers, and branches that can be used to guide the quality manager through potentially complex decision making processes to arrive at a solution to a problem or query. For more information about SmartScripts, see Siebel SmartScript Administration Guide.

Inbox

The Inbox allows managers and other employees to view and approve items (of multiple types) from one screen. In Siebel AECM, the Inbox is used to approve product analyses. For more information, see Siebel Applications Administration Guide.

User authentication

The user authorization check captures and verifies the user's name and password. This user authentication is controlled by the LS Medical User Verification workflow.

NOTE:  User authentication is sometimes called signature capture, but should not be confused with electronic signature capture on mobile devices or tablet PCs used elsewhere in the Siebel Life Sciences application.