MasterControl Validation Excellence (Vx)
Unlike other software providers, we don’t believe in handing you ready-made
validation documentation as a short cut. We want you to fully understand
your software risks and focus on your critical business processes (CBPs).
We developed Vx to accelerate the validation process without sacrificing
a thorough risk evaluation and testing. It will put you in the driver’s
seat by combining a best-practice software lifecycle approach with the use
of an innovative, risk-evaluation tool.
MasterControl Validation Excellence Tool (VxT)
The VxT is the centerpiece of our methodology. The cutting-edge, cloud-based
application is designed to cut your overall validation time from months to
days, if not hours. It will provide you with an assessment of your software
risk, help you leverage MasterControl’s validation protocols, help
you focus on your CBPs, and make a recommendation with regard usage testing.
Installation Qualification (IQ)
The MasterControl software is installed using standardized installation (IQ)
scripts. These execution services are conducted remotely via secure internet
connections for our on-premise clients. Our installation experts will lead
your personnel in the inventory and installation check of your server hardware
to ensure it meets the necessary requirements for systems operation. For
our hosted and cloud clients, our installation engineers will perform all
of the installation steps and provide the executed protocols to you.
Vendor Functional Testing (TOQ)
MasterControl Vendor Functional Testing™ (also known as Transfer Operational
Qualification or TOQ) provides completed validation and support documentation
of functional tests performed at MasterControl. This documentation serves
as objective evidence that basic functions of a MasterControl application
perform correctly against a specification — both functional tests performed
on individual components of the system and operational tests of the whole
system. These automated tests provide full regression testing with every
change. You can "transfer" or assimilate this documentation into your overall
validation effort and documentation, saving both time and money. MasterControl
Validation consultants will walk you through the documentation to guide your
review and acceptance of the materials.
Vendor Usage Testing (PQ)
MasterControl can help guide you through usage testing, also known as performance
qualification (PQ). MasterControl PQ services include the development of
customized PQ protocols based on the recommended testing scenarios from MasterControl
VxT. MasterControl consultants start the development process through the
collection of configuration and usage procedures/work instructions for the
MasterControl quality suite application and by reviewing the results of validation
risk assessment. The collected data is then used to create a baseline protocol
that covers data integrity, security integrity, and electronic approval integrity
testing from processes covering record creation, approval, and secure retrieval.
Typically, this service is contracted as a part of the PQ execution process,
providing a full PQ solution.
Transfer Performance Qualification (TPQ)
MasterControl Transfer Performance Qualification (TPQ) simplifies the usage testing
of software validation for MasterControl customers. To verify that the software
will function according to the customer's user requirements and in the intended
use environment, the TPQ solution has MasterControl conduct all of the usage
testing for all of our modules, based on the best-practice configuration,
thereby shortening traditional testing time from months down to days. FDA-regulated
companies may use the usage validation and supporting documentation as part
of their overall validation efforts and evidence. By producing the reports
necessary to prove validation and providing testing documentation to customers,
MasterControl TPQ reduces the time and cost spent on final testing.
GxP Documentation and Validation Services
MasterControl offers three types of GxP documentation services:
- Pre-IQ/OQ Documentation Services — Development of the validation planning
stage documentation, which includes defining the validation project activities,
user 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 PQ test summary report and a final validation project report.
- Usage SOP Documentation Services — Development of all SOPs to support
the implementation, validation and maintenance of your system. This can
include work instructions for system usage; system administration and
configuration procedures; training procedures; document management procedures.
Validation Solutions Toolkit
MasterControl's Validation Toolkit is a collection of procedural and validation
templates designed to help your validation project team complete the 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.
Contact MasterControl for Validation Services and Solutions
To learn more about MasterControl validation services and solutions, please
contact a MasterControl representative today.