|
 |
| |
Validation services
are designed for customers that need to perform a formal
VIZYX software validation, but lack the resources to
complete the planning and required documentation and
still meet their implementation schedule.
ICM is able to provide experienced and highly qualified
validation engineers offering on-site project leadership
to install the software, perform the validation in a
tutorial mode, provide a “Technical Validation
Package” to the customer, verify that the project
was successfully validated and is ready for the customers
production environment and ensure that Training was
effective.
ICM Custom Validation Services include the following
project deliverables :
- User Requirements – A document which establishes
a condition or capability that must be met by a system
or system component in order to satisfy the need of
a user or a regulation.
- Functional Specifications – A document which
specifies a function that a system or system component
must be able to perform. Establishes operational limits
of the system.
- Installation Qualification Protocol – A document
verifying hardware and software installation. It provides
assurance that the computer system is installed within
limits imposed by the Design Specifications.
- Installation Qualification Report – A document
summarizing the status of the computer system after
the Installation Qualification Protocol has been completed.
It will ensure that all essential activities have
been completed. This report will state the basis for
conclusions and decisions regarding the next phase
of qualification.
- Operational Qualification Protocol – A document
which tests the Functional Specifications of the system.
It provides assurance that the computer system operates
properly within limits imposed by the specification.
- Operational Qualification Report - A document summarizing
the status of the computer system after the Operational
Qualification Protocol has been completed. It will
ensure that all essential activities have been completed.
This report will state the basis for conclusions and
decisions regarding the next phase of qualification.
- Performance Qualification Protocol – A document
addressing the user requirements of the system. It
provides assurance that the computer system operates
properly within the client’s operating environment.
- Performance Qualification Report - A document summarizing
the status of the computer system after the Performance
Qualification Protocol has been completed. It will
ensure that all essential activities have been completed.
This report will state the basis for conclusions and
decisions included in the Master Validation Report.
- Master Validation Report – A document which
summarizes the status of the computer system after
the qualification protocols have been completed. It
will ensure that all essential activities have been
completed. This report will state the basis for conclusions
and decisions regarding the validation status of the
VIZYX application.
Many companies have found this to be valuable to assure
that their schedules and training requirements are met,
and that all issues raised are resolved to their immediate
satisfaction.
|
|