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,
MasterControl Validation Excellence Tool (VxT)
The VxT is the centerpiece of our methodology. The cutting-edge application is designed to cut your overall validation time from months to
days, if not hours. The tool is equally beneficial for those using cloud-based, hosted or premise solutions and will provide you with an assessment of your software
risk, which assists to help leverage MasterControl’s validation protocols, focus
on CBPs and make recommendations with regard to 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 requirement tests performed at MasterControl. This documentation serves
as objective evidence that basic functions of the 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 (TPQ)
MasterControl Vendor Usage Testing (also known as Transfer Performance Qualification or 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, this 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.
Performance Qualification (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.
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 specifications (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, user requirements specifications (URS), 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.