GxP Process Management Software

Easier Compliance. Faster Validation. Better Process Management.

Easier Compliance. Faster Validation. Better Process Management.

MasterControl Customer Complaint Pharma™
Marketing newly-developed pharmaceuticals is a multi-billion dollar business fraught with opportunities for customer
complaints. Mishandled customer complaints can result in serious financial damage to a pharmaceutical manufacturer,
so each complaint must be investigated and analyzed for adverse event reporting. Electronic systems are becoming
significantly more important in effectively handling the documentation needed to respond to customer complaints.

How can MasterControl help you?

MMasterControl Customer Complaint Pharma 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 product engineers for evaluation, so product review and redesign may commence immediately, if necessary. This
offers a tremendous advantage in preserving a company’s reputation from legal entanglements that may arise from unhappy customers
seeking reprisal, whether warranted or not.

Complaint handling is only one aspect of the software; validation is also a key component. 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.

Here’s how MasterControl Cusomter Complaint Pharma addresses some of the major challenges that companies face managing
customer complaints:

Challenges MasterControl Solution

Disconnected Processes: When a company uses tools that
aren’t integrated, tracking complaints and follow-ups can be
a major obstacle. Correction of the problem and resolution of
the complaint may be delayed.
Connected Solution: MasterControl Customer Complaint
Pharma 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 Pharma 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 and injury to a company’s reputation.

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 Pharma 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.

Summary of Features: MasterControl Customer Complaint Pharma 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 Pharma 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.

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

Easier Compliance. Faster Validation. Better Process Management.

• 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
Customer Complaint Pharma 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 Customer Complaint Pharma meets FDA requirements for electronic signature and software validation. It
facilitates compliance with 21 CFR Part 829 regulations and adherence to ISO 9000 and ISO 13485 quality standards..

• Analytics and Reporting Tool: MasterControl Customer Complaint Pharma’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 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 Pharma is Web-based so it can connect all users involved in complaint
handling from virtually anywhere. Via an external link, MasterControl Customer Complaint Pharma 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 Pharma with existing
document repositories and enterprise applications (ERP, LIMS, etc.) can be made easily and immediately, without custom coding.

• CAPA Integration: MasterControl Customer Complaint Pharma gives you the option to integrate customer-complaint handling with
MasterControl CAPA Pharma 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 3500A 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 Pharma 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 Pharma 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 Pharma means getting the necessary technical support to
ensure project success. MasterControl Customer Complaint Pharma offers the expertise, infrastructure.

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.
© 2007 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