MasterControl Customer Complaint MD

MasterControl Customer Complaint MD Software System

Because of the highly competitive nature of the medical device industry, attending to customer complaints is more
important than ever. Complaints filed either directly to the manufacturer or through FDA’s Medwatch may signal an
impending design or material problem resulting in a serious safety issue. The only way to know if a CAPA should be
issued is to track these complaints to determine if a trend is present.

How Can MasterControl Customer Complaint MD Help You?

MasterControl Customer Complaint MD is a complete solution that automates complaint handling, integrates it with
the quality system, and manages complaint resolution swiftly and effectively. Complaint data is instantly available to
quality and regulatory specialists as well as development engineers for evaluation, so product review and redesign may
commence immediately, if necessary. This is a tremendous advantage in today’s litigious society, when slow response to
customer complaints can land a manufacturer in the courtroom.

MasterControl offers a line of validation products and services addressing different levels of validation needs based on
individual risk assessment. They are designed to allow “continuous validation” for FDA-regulated companies by making
validation of software upgrades easier, faster, and more cost effective.

Customer Complaint Handling Challenges MasterControl Customer Complaint MD

Disconnected Processes: When a company uses tools
that are not integrated, tracking complaints and follow-ups
can be a major obstacle. Correction of the problem and
resolution of the complaint may be delayed.
Software System
Connected Solution: MasterControl Customer Complaint
MD connects the complaint process to its quality control
system, providing links to corrective/preventive action
(CAPA) and handling adverse events. Connectivity helps
managers track a complaint from initiation to completion for
faster complaint resolution and indicates trends, if present.

Unnecessary Legal Exposure: Record keeping in a
manual system may be inadequate for answering a
product liability lawsuit. Managers are unable to track
complaints and see the compliance program as a whole,
both of which are essential in developing a strategy for
preventing unwarranted legal exposure.
Controlled Legal Exposure: MasterControl Customer
Complaint MD provides advanced reporting capabilities for
a real-time view of the compliance program. An integrated
program connecting complaints with resolutions may help
reduce legal exposure.

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

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

• Automates Tasks - MasterControl Customer Complaint MD automates all tasks pertaining to handling of customer
complaints, including notification, follow-up, and escalation of overdue assignments. Automation helps simplify the
compliance environment, making it easier to stay compliant.

• Simple Three-Step Process - MasterControl Customer Complaint MD’s advanced reporting capabilities increase
management oversight, making it easy for a product development team to quickly identify product issues, allowing
them to incorporate changes into new designs and avoid past mistakes. The tool also demonstrates appropriate

6322 S. 3000 E. Suite 110 Salt Lake City, UT 84121 P 800.825.9117 F 801.942.7088 MASTERCONTROL.COM
 MasterControl Customer Complaint MD

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

• Web-based Platform - MasterControl Customer Complaint MD is Web-based so it can connect all users involved
in complaint handling from virtually anywhere. Via an external link, MasterControl Customer Complaints MD can be
integrated with other computer systems. For example, a link can be provided on a company Web site or within a CRM
application (or any application that supports URL links), so employees, customers, or partners can easily initiate a
customer complaint.

• Integrates with Existing Repositories for Optimization - Integration of MasterControl Customer Complaint MD
with exiting document repositories and enterprise applications (ERP, LIMS, etc.) can be made easily and immediately,
without custom coding.

• CAPA Integration - MasterControl Customer Complaint MD gives you the option to integrate customer-complaint
handling with MasterControl CAPA MD to automatically escalate any serious quality problem.

• 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. This solution includes the FDA’s MedWatch
3400A form for mandatory reporting of adverse events, allowing a seamless handover to an adverse events specialist
while ensuring that all required data are immediately collected.

• Proactive Monitoring - When installed with MasterControl Rules™, a manager can set thresholds for customer
complaints. For example, MasterControl Customer Complaint MD can send automatic notification to the manager
when a certain product receives 10 customer complaints so the manager can take appropriate action as soon as
possible.

• Continuous validation - For FDA-regulated companies, MasterControl Customer Complaint MD offers a “continuous
validation” approach that dramatically cuts the time, pain, and cost involved in validation.

• Product Training - MasterControl’s Professional Services team has developed a comprehensive training program
that serves as a foundation for successful project implementation and helps companies realize software ROI faster.
The team conducts training at MasterControl’s state-of-the-art Education Center in Salt Lake City and also at
customers’ facilities.

• Technical Support - Choosing MasterControl Customer Complaint MD means getting the necessary technical
support to ensure project success. MasterControl Customer Complaint MD offers the expertise, infrastructure, and
flexibility to meet every customer’s needs, from initial installation to regular maintenance.

About MasterControl Inc.

MasterControl Inc. is a global provider of GxP process and document management software solutions for life science
companies. The MasterControl suite is easy to use, easy to deploy, easy to validate, and easy to maintain. It incorporates
industry best practices for automating and connecting every stage of the product development cycle, while facilitating
regulatory compliance. By combining an integrated platform with a continuum of risk-based software validation products
and services, MasterControl drives down the total cost of ownership and enables customers to extend their investment
across the enterprise. Hundreds of companies worldwide use MasterControl for easier compliance, faster validation, and
better process management. For more information, visit www.mastercontrol.com, or call 800-825-9117.

© 2008 MasterControl Inc. All rights reserved.

6322 S. 3000 E. Suite 110 Salt Lake City, UT 84121 P 800.825.9117 F 801.942.7088 MASTERCONTROL.COM