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ICON
Central Laboratories’ IT Validation Team understands the importance
of software verification and validation in regulated industries.
This department not only plays a role in ensuring that data integrity
is the highest of priorities, it also ensures that proper change
control and configuration management are in place for all systems-based
functions. The Validation Team works closely with each operational
department to ensure that proper requirements are gathered and are
in compliance with our comprehensive policies and procedures. Activities
of the department include, but are not limited to, the following:
- Development and execution of validation;
- Plans and test scripts for new
clinical systems;
- Reviews to ensure appropriate
configuration management is in place;
- Detection and reporting of any
errors;
- Development of summary documentation
for validation projects which is made available to clients during
on-site visits;
- Testing for change requests to
existing clinical systems.
In addition to performing testing
of clinical systems, the IT Validation Team is involved in performing
IT audits for regulatory compliance (i.e. 21 CFR part 11) for internal
systems, potential new systems and affiliate laboratories. |
