MasterControl

Quality Excellence
The Next Generation of the Number One Enterprise
Quality Management System (QMS)
 Solution Overview

MasterControl has been delivering quality

excellence for over 25 years. We continue to
improve our quality management solution to meet
the needs of highly regulated industries – like life
sciences – as they embrace new levels of digitization
and automation and require quality management
practices that are more dynamic, connected and
scalable.

The MasterControl Quality Excellence solution is fully integrated, configurable

and easy to use. It is designed to unite quality and operational excellence while
supporting digital transformation initiatives.

Whether you’re upgrading paper-based or hybrid systems to improve accuracy,

efficiency, and audit-readiness, or consolidating multiple legacy and vendor
systems to a single unified quality platform, MasterControl has a quality
package designed to meet your unique needs.

MasterControl Quality Packages

MasterControl Quality packages combine our cloud-based QMS with
configurable products, process applications, validation services and platform
functionality to provide unmatched flexibility, performance and value.

• MasterControl Quality – Base provides essential quality management

capabilities, digital document management, change control and validation
services so you can quickly implement, operationalize and accelerate your
quality, compliance and product life cycle.
• MasterControl Quality – Standard provides enhanced process applications
and validation, training and exams, along with increased platform
functionality and five business unit licenses.
• MasterControl Quality – Complete provides total quality management by
combining audit management and preventive actions, plus risk and mitigation
process applications and validation along with full platform functionality and
20 business unit licenses.

The World’s Leading Solution for Product Quality 1

 Solution Overview

Each quality package is delivered through the MasterControl Product Lifecycle

Excellence Platform, which provides a single point of information management,
built-in reporting, analytics, and API integrations to ensure quality and
compliance data is visible and accessible across your organization.

Pricing can be tailored based on number of named users and sites.

MasterControl also offers a wide range of industry-leading professional
services, custom integrations, and global language support.

MasterControl Quality Packages

Base Standard Complete

p Documents and Change p Documents and Change p Documents and Change

Training and Exams p Training and Exams p Training and Exams

Incidents and Corrective Action Incidents and Corrective Action p Incidents and Corrective Action

Audits and Preventive Action Audits and Preventive Action p Audits and Preventive Action

Risk and Mitigation Risk and Mitigation p Risk and Mitigation

p Validation p Validation p Validation

p MasterControl Platform p MasterControl Platform p MasterControl Platform

Benefits of MasterControl Quality Packages

Integrated Document and Change Control

• Effectively manage all documents-based processes, with automatic revision
control, and maintain all documentation in a single repository.
• Streamline change procedures for faster turnaround, and integrate change
control with related processes to form a closed-loop solution.
• Included with all MasterControl quality packages.

The World’s Leading Solution for Product Quality 2

 Solution Overview

Comprehensive Training Management

• Easily compile and view training documentation in one location.
• Send out automatic training tasks when standard operating procedures
(SOPs) or any document type that requires training, are changed to ensure
employees are always up to date.
• Included with the Quality – Standard and Quality – Complete packages.

Who Benefits From CAPA Management Integration

MasterControl • Initiate a corrective and preventive action (CAPA) directly from other quality
Quality Packages: event forms, eliminating the possibility of introducing mistakes that can come
from manually retyping information.
• Quality Assurance Directors
• Quality Managers • Automatically track the CAPA process, and escalate issues to ensure
and Trainers effective resolution.
• Audit Managers • Included with the Quality – Complete package.

Audit Management
• Track audits automatically on an audit calendar, manage the entire audit
process, and ensure findings are resolved.
• Grant auditors controlled, limited access to the system to review
documentation.
• Included with the Quality – Complete package.

Risk and Mitigation Management

• Avoid death by CAPA by using our risk gateway to determine when one is
needed.
• Capture a complete picture of the risk landscape across the entire business.
• Included with the Quality - Complete package.

The MasterControl Difference

End-to-End Quality
Management
Quality processes all affect
each other. That’s why
MasterControl’s solutions
interconnect, so you can
initiate a corrective and
preventive action (CAPA)
from a complaint form,
connect training to standard
operating procedures,
and more.
Digitize and Connect
Quality isn’t a department —
it’s at the heart of the entire
product life cycle. Without
it, nothing else that happens
in the product life cycle
matters. MasterControl
infuses quality into every
stage of the product life
cycle, ensuring quality at
the source and compliance
throughout the process.
Robust Reporting and
Analytics
Quality generates vast
amounts of data. But
that data doesn’t do your
company any good if you
can’t connect and analyze it.
With connected quality
data from multiple
modules you can generate
customized, useful reports
and visuals to improve your
decision-making.
Used and Approved by
Regulators
Our customers use
MasterControl to pass
regulatory inspections.
Even more impressive is that
the regulators themselves
use MasterControl, including
five of the largest regulatory
and applied research bodies
in the United States.

The World’s Leading Solution for Product Quality 3

 Solution Overview

Unlock the Power of Your Data

MasterControl Insights Every cloud instance of MasterControl includes MasterControl Insights. Insights
Turn static, siloed is an interactive business intelligence and data management tool that gives you
information into actionable
complete access to your data. Pre-configured, role-based dashboard visualisations
intelligence. Transform
product development with give you a comprehensive view of quality and manufacturing processes.
dynamic data management
and exploration through Additional Insights Features:
powerful, personalised
reporting and dashboards. • Customised dashboards to meet your business needs
• Robust reporting
• Advanced analytics and artificial intelligence (AI) capabilities
• Export application programming interface (API)
• Key performance indicator (KPI) management

About MasterControl
MasterControl Inc. is a leading provider of cloud-based quality, compliance and
production management software for life sciences and other regulated industries.
Our mission is the same as that of our customers – to bring life-changing products to more
people sooner. The MasterControl Platform helps organizations digitize, automate
and connect critical processes across the regulated product development life cycle.
Learn more at mastercontrol.com

© 2022 MasterControl Inc. All rights reserved.

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