8/8/2019 MasterControl Customer Complaint MD Software System

http://slidepdf.com/reader/full/mastercontrol-customer-complaint-md-software-system 1/22 S. 3000 E. Suite 110 Salt Lake City, UT 84121 P 800.825.9117 F 801.942.7088 MASTERCONTRO

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 led either directly to the manufacturer or through FDA’s Medwatch may signal animpending 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

Software System

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.

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. 

Inefcient 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.

Efcient 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

notication, and incorporates escalation to ensure timelyresponse.

MasterControl Customer Complaint MD is a robust software solution that manages complaint handling more efciently

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 notication, 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

MasterControl Customer Complaint MD

8/8/2019 MasterControl Customer Complaint MD Software System

http://slidepdf.com/reader/full/mastercontrol-customer-complaint-md-software-system 2/22 S. 3000 E. Suite 110 Salt Lake City, UT 84121 P 800.825.9117 F 801.942.7088 MASTERCONTRO

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 notication 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

exibility 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.

 

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MasterControl Customer Complaint MD