Pharmaceutical, BioTech, and Medical industries.
Pharmaceutical, BioTech, and Medical industries.
identified, inspected and installed per the manufacturer's recommendations.
Installation Qualifications are generally required for new or existing equipment/instruments
that have been relocated.
an annual or bi-annual schedule. Re-Qualification certifies that the equipment/instrument is
continuing to operate in an acceptable state of accuracy, stability, and uniformity.
in a formal documentation process that tests that functionality and accuracies are achieved.
Operational Qualification is required following the installation Qualification process.
The tests that are conducted during an Operational Qualification will verify that the
equipment/instrument, alarms, controller, and ECMS is in good working order,
and that the chamber is ready for operational challenges.
as a system in a formal documentation process to ensure that specific control setpoints
are able to achieve passing results based on precise acceptance criteria.
Performance Qualification is required following the operational qualification process.
The Performance Qualification will specifically challenge the equipment/instrument for
accuracy, uniformity, stability, and the ability to recover from an out of tolerance condition.
for a wide array of equipment, warehouses, and facilities across
the United States and Canada. We have the ability to draft and
execute our own protocols to ensure your testing needs are met
or exceeded.
that accurately and succinctly display the results/process of testing.
continued compliance according to your schedule.
the highly regulated Pharmaceutical, Biotechnology, and Medical Device Industries.
Pharmaceutical, BioTech, and Medical industries.