SmartComplaints Setup

 

Organization Setup

Object

Shared with other SmartSolve© Applications

Required for SmartComplaintsTM

Organizations

Yes

Yes

Departments

Yes

Yes

Standard Operations

Yes

No

Operations

Yes

No

Clients

Suppliers, Customers, Regulatory Bodies, Importers/Distributors

Yes

Yes

Contact Type

No

Yes

Work Centers

Manufacturing Sites

Reporting Sites

Yes

Yes

Production Lines

Yes

No

Machines

Yes

No

Plant Areas

Yes

No

Country of Origin

No

No

Submission Reporting Site

No

No

 

User Management Setup

Object

Shared with other SmartSolve© Applications

Required for SmartComplaintsTM

Rights Groups

Yes

Yes

Roles

Yes

Yes

Users

Yes

Yes

Single Sign On

Yes

No

 

Product Setup

Object

Shared with other SmartSolve© Applications

Required for SmartComplaintsTM

Product Line

Yes

Yes

Part

Yes

Yes

Product Type

No

No

Unit of Measurement

Yes

No

 

Failure Mode Setup

Object

Shared with other SmartSolve© Applications

Required for SmartComplaintsTM

Failure Modes

Yes

Yes

Failure Mode Category

Yes

Yes

Severity

Yes

Yes

Cause

Yes

No

Cause Category

Yes

No

Failure Mode Update

Yes

No

 

Exception Setup

Object

Shared with other SmartSolve© Applications

Required for SmartComplaintsTM

Exception Type

Yes

Yes

Lot Number Import

No

No

Numbering Schemes

Yes

Yes

Priority

Yes

Yes

Activity Types

Yes

No

Activity Signatures

Yes

No

Reference Types

Yes

No

Requested Action

No

Yes

Sample Location

No

No

Exception Resolution

No

Yes

Exception Policies

Yes

No

Exception Auto Rules

Yes

No

Response Letters

No

No

Decision Tree

No

No

Capture Complaint Updates

No

No

CSA Integration

No

No

 

Manual Reporting Setup

Object

Shared with other SmartSolve© Applications

Required for SmartComplaintsTM

Numbering Schemes

Yes

Yes

Submission Status

No

Yes

Regulatory Reporting Policies

No

No

PDF Template Configurations

No

No

 

eMDR Reporting Setup

Object

Shared with other SmartSolve© Applications

Required for SmartComplaintsTM

Numbering Schemes

Yes

Yes

Submission Status

No

Yes

Regulatory Reporting Policy

No

Yes

FDA eSubmission Link

No

Yes

MedWatch PDF Template

No

Yes

MedWatch HTML Template

No

Yes

Country Codes

No

Yes

State Codes

No

Yes

CDRH Codes

No

Yes

Submission Codes

No

Yes

 

eMDV Reporting Setup

Object

Shared with other SmartSolve© Applications

Required for SmartComplaintsTM

Numbering Schemes

Yes

Yes

Submission Status

No

Yes

Regulatory Reporting Policies

No

Yes

MedDEV PDF Template

No

Yes

MedDEV HTML Template

No

Yes

Validation Configuration

No

Yes

 

Issue Setup

Object

Shared with other SmartSolve© Applications

Required for SmartComplaintsTM

Results of Investigation Task

Yes

No

 

Introduction

As an administrator it is important to become familiar with the various setup and policy tables available off the shelf with SmartComplaintsTM

Please see the SmartComplaintsTM End User Guide for more information on SmartComplaintsTM end user functions and how to maintain end user records once the system is configured.

 

Complaint Process Mapping

Prior to configuring the SmartComplaintsTM system, meet with the key stakeholders of SmartComplaintsTM. You should discuss exactly what business requirements must be met in the system, who is responsible for these requirements, and the standards for the completed requirements. 

This common practice is not only needed to configure the SmartComplaintsTM system successfully; but also  helps Pilgrim customer’s to revisit their business processes and work to ensure that these processes are effective and efficient (continually improved to ensure processes use the least amount of resources).

 
Process Mapping Pointers

Some important things to consider when implementing SmartComplaintsTM:

 

 

Complaint Workflow Diagram

 

What are Complaint Codes?

Complaint Codes are failure modes and can be setup the same way; however they can be made specific to the type of complaint that is being recorded (i.e., inquiry complaint codes may be different than adverse event or product malfunction codes). If using SmartCAPATM with SmartComplaintsTM and you wish to keep your complaint codes separate then you can also use this option in setup.

 

Example Complaint Code Matrix

Exception Type

Complaint Category

Complaint Code

Product Complaint

 

Packaging

Mechanical Malfunction

Damaged Container

Balloon Burst

 

Inquiry

Packaging

Documentation

Clarification

Missing Documentation

 

 

SmartComplaintsTM Integration

 

Complaint Data Sources

 

Anyone can submit a complaint exception. Exceptions can come from customers, end users, or distribution partners, etc. The importance of the exception record in SmartComplaintsTM is having the ability to track, record, classify and trend all the exceptions that are submitted.

The illustration below shows some of the different ways in which exceptions could be reported in SmartComplaintsTM:

 

Data Source Scenarios

The scenarios below explain a little more in-depth how the complaint reporting examples above could be carried out using SmartComplaintsTM:

Scenario

Description

Field Service Scenario

People in the field could have the data entry form on their lap tops so that they could enter the information into their template while in the field. Once back in the office, they connect to the network (within the office or via VPN connection), access the solution over the server, then synchronize and upload the complaint into the SmartComplaintsTM exception record.

 

Customer Services Scenario

Customers may call in to submit a complaint. In such cases, a customer service representative would typically enter the information locally into their CRM system. The CRM system would then synchronize with SmartComplaintsTM and push the information into the SmartComplaintsTM record.

 

Customer/Partner Scenario

Customers/Clients may also submit their complaints directly through your company website. The information which is entered through the web site can then be pushed into SmartComplaintsTM to be managed and resolved through the SmartComplaintsTM record.

 

 

NOTE: These approaches would require interfacing with systems such as CRM systems or web sites. However, the event can also be entered manually by the user. The next step in the process is recording an exception (event) in SmartComplaintsTM with all required information and validated data.