Data Sheet

MasterControl Training™
FDA regulations, ISO standards, and other international regulations require
training as an integral part of quality. MasterControl’s training software is a
learning management system (LMS) designed to help you integrate quality into
your daily operations and facilitate compliance. It provides robust tools to help
prevent quality problems and to show regulators that your quality standards
and policies work.

How Can MasterControl Software Solutions Help You?

MasterControl Training automates and streamlines paper-based or hybrid training
systems. It facilitates compliance with training requirements found in FDA and
other regulations, as well as ISO and other quality standards. MasterControl
Training offers the following benefits.

Challenges and Solutions

Training Control Challenges MasterControl Training

Inefficiency: In regulated environments, employees Increased Efficiency: MasterControl Training greatly

whose jobs directly affect product quality must
be trained on relevant SOPs, policies, and other
critical documents. A paper-based system requires
distribution of training materials, tasks, reminders,
and exams in person or via phone or email. Without
vigilance, tasks can fall through the cracks.
increases efficiency by automating management of all
training tasks, from routing to follow-up and escalation.
It offers the capability to provide online exams, group
sign off for companies that train large groups, and
automatic sequencing of training tasks for progressive
training.

Disparate Systems: Any substantial change to an
important document typically requires retraining on
the updated document. When the document revision
and training systems are different, employees could
miss training tasks and continue to perform their jobs
based on outdated information.
Connected Processes: MasterControl connects training
with document revision and all other quality processes
for a holistic approach to quality management and
compliance.

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 Data Sheet

Unnecessary Administrative Burden: Training Reduced Administrative Burden: MasterControl

coordinators spend most of their time routing and automates routine tasks so training coordinators can
tracking training tasks. They spend equal amount focus on the quality of the curriculum and effectiveness
of energy in testing, verifying results, and tracking of the training.
completion of tasks.

Lack of Oversight: With a manual process that
depends on spreadsheets, it is hard to see who needs
what training when; how many users passed or failed;
and how many have completed training.
Increased Oversight: MasterControl’s Job Code Matrix
displays an up-to-date view of the training status of
employees who have been grouped by Job Code. The
training system’s analytics and reporting capability
will help you track and address training gaps and
deficiencies.

Unprepared for Audits: Most auditors scrutinize
training records. Under a manual system, tracking
and preparing each employee’s training file requires
enormous effort. Paper records can be easily misplaced,
creating issues during audit.
Increased Audit Preparedness: MasterControl Training
provides a centralized, web-based repository for all
training documents, so users and auditors will find all
the documents they need in one place, greatly increasing
audit readiness.

Inefficient Competency Assessment: It’s not enough
to train employees; you want to make sure they
understand the material to do their jobs properly. It’s
easy to neglect testing under a manual system because
everything takes more effort.
Efficient Competency Assessment: MasterControl’s
user-friendly features facilitate testing and ensure
greater user acceptance. They include the capability
to save an exam if the trainee is interrupted and add
pictures to exams to help explain complex questions.

Summary of Features & Benefits

Automated Training Control and Management: MasterControl automates all

routine activities, from distribution of tasks, materials, and exams to follow-up,
tracking, escalation, and verification. With automatic revision control, only one
authorized user at a time can revise a particular training material to avoid multiple
revisions of the same document.

Training Folder: Each trainee has a personalized virtual folder that shows the
person’s past training, course due dates, and future training tasks. Trainees can
get a quick overview of their required curriculum as well as sign-up for elective
courses.

Multiple Training Types: The system allows creation of a multi-format

curriculum, including controlled document review, computer-based training, on-
the-job training, assessments, as well as instructor-led training.

Job Code Matrix: This feature provides an up-to-date view of the training status
of employees who have been grouped by Job Code. The system will show the
status of each course assigned to each employee and the completion percentage
for that Job Code.

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 Data Sheet

Online Exams: MasterControl automates testing, grading, and documentation of

each user’s training history. The following user-friendly features facilitate testing
and ensure greater user acceptance.

• Add Pictures: MasterControl has the capability to add multimedia materials,

such as pictures and videos, for a more compelling testing. This is crucial for
complex topics that are best described visually.

• Save Exams: Trainees who get interrupted while testing will be able to save
their exams and pick up where they left off later.

• Get Instant Feedback: Exam designers have the option to alert trainees when
they answer a question incorrectly. End users will get direction on what part
of the course material they should review.

Powerful JReport-driven Analytics Tool: This highly customizable tool allows

users to view, filter, and interact more with their data. It provides robust charting
capabilities and two user modes: viewer and editor. The latter allows users to
change column size, add or remove columns, create new data columns, and more.

Faster Validation with MasterControl Validation Excellence Tool (VxT):

MasterControl’s innovative, cloud-based risk-evaluation tool cuts down the
validation time from months to days or hours. The VxT is the centerpiece of
the MasterControl Validation Excellence (Vx) methodology, which focuses on
validation of critical business processes.

SCORM Compliance: MasterControl is compliant with SCORM (Shareable

Content Object Reference Model), which means it can interact with e-learning
software. End users will be able to access SCORM-compliant courses in
MasterControl.

MasterControl Training

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 Data Sheet

On-the-Job Training (OJT): Verifiers can complete an observation form

and attach it to the training record as evidence of the trainee’s proficiency in
performing the assigned task.

Group Sign-off: For companies that train hundreds of employees at once, verifying
and signing off for each trainee can be time-consuming. With this feature, the
course instructor or verifier can sign off once for large groups of trainees.

Progressive Training Sequence: MasterControl allows development of a

progressive training program through sequencing of training courses. As soon as a
trainee completes a prerequisite, the next course is automatically launched.

Classes and Course Materials Control: Users who have not attended a training
class or opened a course material will not be able to sign off on the task. This
feature enforces training and compels users to open training materials.

About MasterControl

MasterControl Inc. creates software solutions that enable life science and other
regulated companies to deliver life-improving products to more people sooner.
MasterControl’s integrated solutions accelerate ROI and increase efficiencies by
automating and securely managing critical business processes throughout the
entire product lifecycle. More than 1,000 companies worldwide, ranging in size
from five employees to tens of thousands, rely on MasterControl cloud solutions
to automate processes for new product development, clinical, regulatory, quality
management, supplier management, manufacturing and postmarket surveillance.
MasterControl solutions are well-known for being scalable, easy to implement,
easy to validate and easy to use. For more information, visit
www.mastercontrol.com.

© 2019 MasterControl Inc. All rights reserved.

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