Data Sheet

Validation Services and Solutions

MasterControl provides validation services and products based on industry best
practices to meet your compliance, validation and process change management
needs. Whether you’re looking for minor assistance or more comprehensive
guidance, MasterControl’s seasoned validation specialists can help you meet
regulatory requirements and complete your system’s process compliance.

Services
Validation Training

If your organization is new to validation, MasterControl offers validation training

that will guide you through FDA and GAMP regulations and methodologies for
validating automated systems, applications or processes. The training familiarizes
personnel with the proper methods for planning and executing a computer
systems validation project; provides examples and exercises on the usage of the
MasterControl Validation Toolkit and test protocols; and addresses topics such as
common mistakes during execution that often delay projects.

GxP Documentation Services

MasterControl offers three types of GxP documentation services:

• Pre-Installation Qualification (IQ)/Operational Qualification (OQ)

Documentation Services — Development of the validation planning stage
documentation, which includes defining the validation project activities,
requirements, time frame and scope. Deliverables include the validation plan
and User Requirements Specification (URS).

• Test Reporting Documentation Services — Development of the testing

summary reports and final validation report for the project. This
documentation includes a review of all testing and project milestone
information for a Performance Qualification (PQ) test summary report and a
final validation project report.

• Usage Standard Operating Procedure (SOP) Documentation Services —

Development of all SOPs to support the implementation, validation and
maintenance of your system. This can include work instructions for system

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usage; system administration and configuration procedures; training

procedures; document management procedures.

Protocol Services and Custom Protocol Development

MasterControl can help you in the complete development of customized

PQ scripts. To help you develop a customized PQ protocol, a MasterControl
consultant will help identify usage procedures/work instructions for the
MasterControl product. The collected data is then used to customize the
scripts to create a protocol that covers the specified critical business process,
i.e., processes that are crucial to daily business operations or could affect data
integrity or patient health.

Products
Validation Toolkit

MasterControl’s Validation Toolkit is a collection of procedural and validation

templates designed to help validation project teams complete requirements
for validation projects. The toolkit consists of project-level and corporate-
level templates of validation documentation items and procedures such as
the validation plan, URS, Functional Requirements Specifications (FRS), FDA
certification letters and various procedures based on industry examples.

Automated Transfer Operational Qualification (ATOQ) Solution

MasterControl’s ATOQ solution provides completed validation and support

documentation of IQ/OQ tests performed at MasterControl. This documentation
serves as objective evidence that basic functions of a MasterControl application
performs correctly against a specification – both functional tests performed on
individual components of the system and operational test of the whole system.
You can “transfer” or assimilate this documentation into your overall validation
effort and documentation, saving both time and money.

Transfer Performance Qualification (TPQ) for Spark Solution

MasterControl’s TPQ solution simplifies the PQ portion of software validation

for customers of Spark, MasterControl’s hosted QMS for companies with fewer
than 50 employees. To verify that the software will function according to the
customer’s user requirements and in the intended use environment, the TPQ
offering has MasterControl conduct all of the PQ testing for Spark customers.
With MasterControl’s TPQ solution, Spark customers spend no time at all
executing anything for the PQ. FDA-regulated companies may use the PQ
validation and supporting documentation as part of their overall validation efforts
and evidence.

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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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