Data Sheet

MasterControl Implementation
Combining experience and industry best practices to accelerate
your solution’s time to value.

Unmatched team experience.

Maximum implementation efficiency.

When you purchase a new enterprise solution, you want more than just a viable
software implementation. You deserve a future-ready system that will facilitate
your long-term success — and you need a team of experts with the track record to
back it up. Successful deployments are dependent on knowledgeable leaders who
have the requisite experience and a proven strategy.

Our Professional Services Team has performed thousands of successful

implementations, validations, and integrations over the past 25 years. From the
moment you decide to implement a MasterControl software solution, our driven
team — led by a dedicated technical project or program manager — will guide you
through every step of our time-tested implementation process and make sure
you’re continually informed of the key milestones, each team members’ functions
and progress, and project timelines.

A MasterControl product implementation can entail up to four different

components:

Implementation
We’ve deployed thousands of solutions that resolve the trickiest data, process,
and technology pains. By combining expertise with well-established industry best
practices, we’re able to deliver the ideal solutions for meeting your
business objectives.

Validation
Our proven validation process delivers the fastest validation times the industry
has to offer without sacrificing compliance. With our patented (U.S. Pat.
10,324,830) Validation Excellence Tool (VxT) accelerator, we’re able to give you a
fast, efficient, seamless and compliant validation experience that other providers
couldn’t dream of matching.

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Technical Architecture and Engineering (TA&E)

Beyond your foundational implementation, you may also choose to have us

help you generate reports that are unique to your organization’s processes and
specifications to help you get the added insights and visibility you need to thrive.
We also offer opportunities for you to optimize your MasterControl solution
architecture by merging data sources, making extractions, performing mass
updates, making data changes and other enhancements that will streamline
system performance.

Services Technology Solutions (STS)

If integrations are your top priority, MasterControl’s STS team empowers you to
get more value out of your solution by turning your solution into a business-critical
tool. By helping you create third-party integrations via MuleSoft, the STS team
establishes your MasterControl solution as part of your business-critical stack.
The team can help you develop customized quality event forms that are uniquely
designed in alignment with your processes and business information needs.

The MasterControl Implementation Process:

A Track Record of Excellence

MasterControl’s verified implementation approach is focused on providing

you with beginning-to-end resources, trusted expertise, and dedicated,
caring support teams that guide you along each step of the way. With 25
years of experience under our belt, our six-step methodology has proven to
be the most efficient, reliable, and compliant implementation process the
industry has to offer.

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Phase 1 – Plan
Our initiation phase starts with a project kickoff where you’ll meet the
MasterControl team that will support you through the implementation process
and we’ll work together to identify all the project’s functional owners and
stakeholders. The strategic planning process takes place up front to drive
improved outcomes. In this stage, we’ll work together to identify clear roles and
accountabilities and align our teams. We will collaborate to come up with goals
and an implementation plan.

Phase 2 – Discover
In an introductory site planning session, we’ll thoroughly explore your
current status to fully comprehend how your teams work together. This joint
discovery between your personnel and the MasterControl configuration,
validation and project management experts who will be working together on
your implementation will enable us to identify which industry best practice
best matches your needs so we can bridge the gaps with your MasterControl
solutions. The ultimate objective of the discovery phase is to come to a mutual
understanding of what needs to be done to bridge gaps and solve your
business problems.
The discovery phase provides an opportunity to identify routing and workflow
requirements, storage and organizational access points, and other key
configuration elements. It is also a period used for stakeholders to collaborate
and define the design inputs and outputs and the workflow, automation, and
reporting output requirements. The training of the system’s functional owners and
administrators begins in the discovery phase as well, which includes any sysadmin
training certification that may be applicable.

Phase 3 – Configure
All the information gathered during the discovery phase will be compiled into
a specification that outlines how we plan to design your configuration before
applying it to your site. Together we’ll review and organize all the configuration
elements so we can establish the application’s structural design and metadata
components as well as all the appropriate vaults, lifecycles, routes, InfoCard
types, roles, job codes, courses and other elements specific to your MasterControl
product. We’ll also create user accounts and settings for roles and security help
you prepare for your use-case scenario testing.
We want to make sure your solution meets your business need before moving
forward with validation and deployment, so this is a critical phase for you to
explore and kick the tires on your new system, either in a test or dev environment,
whichever you prefer. We’ll leave plenty of time for you to work out any kinks in
your processes and ensure tat a satisfactory amount of user acceptance testing
has been performed before finalizing your baseline system configuration. Also
during this phase, your consultant will teach you how to populate MasterControl’s
document import tool in preparation for importing data when your system
goes live.

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Phase 4 – Validate
When the user requirement specifications (URS), validation plan and configuration
have been approved along with your user acceptance testing, it’s time to begin the
validation phase. Your MasterControl validation specialist, who is available to you
throughout each phase of the implementation, will now become your point person.
Together you’ll review the Transfer Operational and Performance Qualification
(TOQ/TPQ) documentation and complete your risk assessment. Your validation
specialist will teach you everything you need to know about MasterControl’s
revolutionary VxT, our patented validation mechanism that is the closest thing
to a validation accelerator that exists on the market. The VxT empowers our
customers to perform a complete validation in just days or even hours. It provides
you with the necessary information to understand and prioritize your testing
requirements based on the actual risk of implementing MasterControl software
to your specific critical business processes. Rather than validating your entire
system, VxT helps you identify high-risk items so you know what to conduct
specific testing on.
We won’t move on until you’re completely assured that your system is validated
and compliant. Before advancing to the deployment phase, you’ll be able to review
and approve the VxT risk assessment, your recommended usage test scripts and
the final validation report.

Phase 5 – Deploy
When you’re satisfied with your solution’s validation, you’ll have a Go Live-
readiness meeting with your configuration consultant. Together you will review
any questions or outstanding items for the Go Live engagement and ensure your
import files are ready. This phase also provides the perfect opportunity to perform
any dry run imports into your test environment to make sure you are satisfied with
the status of your data. We’ll also install or import any final templates that may
be applicable to your solution.
Once you’ve developed your user training materials, administrative procedures
and the “Train the Trainer” training, you’ll be ready to import and enable all
your users, documents and workflows. It’s time to Go Live! If you’re a current
MasterControl customer, you’ll get your new solution manually copied into your
current instance by your consultant right before going live. If you’re new to the
MasterControl experience, there won’t be any need for copying since your solution
will already be in production.

Phase 6 – Onboard
Your project doesn’t end just because your solution is now operational. Your
configuration consultant will host post-Go Live engagements to respond to any
additional needs you may have and double check that your solution is meeting
your expectations. This phase also provides a path for you to arrange learning
opportunities for your power users that span a variety of topics so they can ensure
that all users are comfortable with your new system. If you’ve opted to include
hypercare as part of your project, you will have a dedicated consultant with you
every step of the way to ensure a smooth transition and usage adoption from
end users.

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Be aware that the phases in the MasterControl implementation cycle are not
always sequential. There are often overlaps among the different stages or times
when certain aspects of different phases may occur concurrently, depending on
your individual circumstances.

MasterControl’s Six-Phase Implementation Process

Your success is our top priority, so we want your new solution up and running as
quickly as you do — and we have the expertise and best practice methodology to
get it done. We will match the pace you’re comfortable with and work as fast as
you are able. Each customer’s implementation time varies according to the scale
of the project, the readiness of the organization’s data, the number of solutions
purchased, and many other customer-dependent variables. Be mindful of the
balance of duties your personnel will be expected to maintain between their
daily job responsibilities and the implementation project tasks you’ll be asking
them to fulfill. The availability of your implementation personnel can affect the
implementation timeline.

Partnering for Success: Our Joint Implementation Team

Representatives from both our organizations will work together to ensure the
efficiency and precision of your implementation project.

Customer Roles MasterControl Roles

Executive Sponsor Technical Project or Program Manager

This senior staff member is responsible to your business This experienced MasterControl staff member
for the success of the implementation project and will be your primary contact who will manage the
will serve as the primary contact in cases where an implementation from planning stages to Go Live
escalation might be necessary. and beyond.

Project Manager Configuration Consultant and Engineer

Your senior management will assign this person to drive This expert will provide implementation consulting
the project forward, which includes the coordination of on your applicable solutions.
time and resources.

Subject Matter Expert(s) Technical Architects and Engineers

One or more experts from each of your business units Data specialists who help provide custom data solutions
will help define their respective divisions’ requirements and insights to help you meet your
of the system. unique needs.

Validation Resources Validation Specialist

At least two people will need to oversee validation from
the customer side: one validation approver will ensure
the system is valid and the other person will support
the approver and participate in validation activities as
required.
This industry and product expert will direct, coordinate,
and manage validation activities throughout the entire
implementation process.

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IT Resource STS Engineers

At least one internal IT expert will be needed to
support the technical setup for Single Sign-on (SSO)
and to verify that all workstations meet the minimum
requirements defined in the MasterControl
Client Recommendations.
Integration gurus who ensure your MasterControl
solution is streamlined with reliable integrations that
interconnect your business systems to ensure
data accuracy.

Trainer(s)
Depending on the number and type of solutions you’ll
be implementing, one or more MasterControl education
experts will be available to provide
product training

Customer Specialists

Executive
Sponsor

Project
Manager

Validation Subject Matter

IT
Resources Experts

MasterControl Specialists

Technical Project
or Program Manager

Configuration
Technical Architects
Specialist and Validation Specialist Trainer STS Engineers
and Engineers
Engineer

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Out-of-This-World Implementation Services, Available

Anywhere in the World
Our full range of Professional Services are provided worldwide. Services can be
obtained directly from MasterControl in North America, Europe, Japan and Asia-
Pacific regions or through authorized partners in other geographies.

About MasterControl
MasterControl Inc. is a leading provider of cloud-based quality and compliance
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
quality and compliance processes across the regulated product development
life cycle. Over 1,000 companies worldwide rely on MasterControl solutions to
achieve new levels of operational excellence across product development, clinical
trials, regulatory affairs, quality management, supply chain, manufacturing and
postmarket surveillance. For more information, visit www.mastercontrol.com.

© 2019 MasterControl Inc. All rights reserved.

DSSVXXENLT-12/19

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