An important part of regulatory compliance
is validation. The FDA and other regulators
require that all equipment, systems and
processes be validated for compliance.
Validation is intended to assure regulators
that the process or system in question will
meet all established acceptance criteria;
like all things regulatory, this validation
must also be documented thoroughly.
All validation documents must be made
available to the FDA or other regulators upon
demand. And in an increasingly digital world,
validation of all GxP computerized systems
is especially important; these must be
validated before being placed into service
and re-validated as needed. For instance,
a software upgrade may warrant a
re-validation of a system.
Please fill all the required * fields.