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MasterControl Customer Complaints

MasterControl Customer Complaints™

Customer complaints are inevitable in any kind of business. They are especially critical in the life sciences and
general manufacturing industries, where complaints may indicate serious safety issues. In both FDA and ISO
environments, customer-complaint handling is considered an essential part of the quality system — and an
important factor in ensuring compliance.

How Can MasterControl Benefit You?

MasterControl Customer Complaints™ is a complete and easy-to-use solution that will help you automate
complaint handling, integrate it with the quality system, and manage complaint resolution more effectively.
Here’s how it can answer key challenges in the customer complaint process:

Customer Complaints Handling Challenges MasterControl Customer Complaints™

Different Sources: In a manual system, customer Centralized Source: MasterControl Customer
complaints may come from different sources (e-mail, Complaints software provides a secure and centralized
phone, fax, letters, corporate Web site, sales reps, etc.). platform for receiving customer complaints and storing
These complaints may languish in someone’s “in” box, all subsequent documentation pertaining to investigation
especially if there is no formal and standard procedure and correction of the problem. A single, cohesive system
for processing them. Without a cohesive structure that makes search and retrieval of complaints and related
captures complete information in a timely manner, it is data easy. The solution offers the capability to formalize
almost impossible to formulate a strategy for complaint and standardize complaint handling through a simple
resolution. three-step process. MasterControl is Web-based, so
customers can log complaints from virtually anywhere.

Disconnected Processes: When a company uses Connected Software System: MasterControl connects
different tools that are not connected, tracking the customer-complaint process to the rest of the
complaints and follow-up work can be a major obstacle. quality system, providing links to corrective actions and
If there is no standardized response to complaints, the adverse-event handling. Via an external link, customers
required documentation may fall through the cracks and can integrate MasterControl Customer Complaints
correction of the problem may be delayed. with other computer systems. For example, a link can
be provided on a company Web site within a CRM
application (or any application that supports URL links),
so employees, customers, or partners can easily initiate
a customer complaint. Connectivity will help managers
track a complaint from initiation to completion and give
them the ability to proactively improve the complaint

Inefficient Complaint Process: A manual system Efficient Complaint Process: MasterControl reduces
is plagued by bottlenecks: misplaced or overlooked the life cycle of the complaint process by streamlining
complaints coming from disparate sources, incomplete different steps and consolidating multiple sources
information, lack of follow up, and inadequate response. of complaints under a single platform. It provides
All of these can result in delayed complaint resolution. a customizable form that captures all necessary
information, provides automatic follow-up via e-mail
notification, and incorporates escalation to ensure timely

phone: 800.825.9117 web: www.mastercontrol.com email: info@mastercontrol.com

MasterControl Customer Complaints

MasterControl Customer Complaints is a robust software solution that manages complaint handling more
efficiently and effectively with the help of the following features:

Simple Three-Step Process: This best-practice process is incorporated in a pre-configured, multi-page form
that starts with the processing of a customer complaint by the coordinator/manager, automatically moving to
the internal investigation step (conducted either by an expert or a team of experts), and culminating with a
resolution of the issue as approved by the appropriate manager. Additional forms can be customized according
to a company’s special needs.

Compliant System: 21 CFR Part 11 requires an audit trail as a key control in making electronic records
reliable. MasterControl maintains a secure, time-stamped audit trail that documents the identity of anyone
who creates, modifies, or deletes an electronic record (such as a customer complaint file), when the action
occurred, and the changes made to the record. MasterControl meets FDA requirements for electronic signature
and software validation. It facilitates compliance with regulatory standards such as ISO 9000, ISO 14000, and
ISO 13485.

Analytics and Reporting Tool: MasterControl’s advanced reporting capabilities increase management
oversight and demonstrate appropriate controls to regulatory agencies. The solution includes the following
customizable reports:

• Complaint summary
• In-process complaints
• Complaints categorized by type, product, and department
• Trending categorized by complaint type, product, and department

MedWatch Form: For an FDA-regulated company, a customer complaint may turn out to be the reporting of an
adverse event, which comes with its own set of regulatory requirements. MasterControl Customer Complaints
includes the FDA’s MedWatch 3500A form for mandatory reporting of adverse events, allowing a seamless
handover to an adverse events specialist while ensuring that all required data is immediately collected.

CAPA Integration: MasterControl gives you the option to integrate customer-complaint handling with the
corrective and preventive action CAPA process to automatically escalate any serious quality problem.

Sustained Compliance: Regulated companies cannot ignore customer complaints. They are the ultimate
indicators of product/service quality. Every complaint has to be properly evaluated, investigated, and the
situation corrected. MasterControl Customer Complaints is designed to streamline and simplify the complaint
process, foster efficiency throughout the enterprise, and keep compliance costs down. MasterControl will not
only help you attain FDA and ISO compliance — but sustain it year after year. With MasterControl, you can
count on a partner that will support your compliance efforts over the long haul.

© 2009 MasterControl Inc. All rights reserved.

phone: 800.825.9117 web: www.mastercontrol.com email: info@mastercontrol.com