With instrument validation an integral part of many analytical
procedures and protocols, its good to know that LAT
can help you with your IQ/OQ and CFR21 requirements.
There are four main areas that need to be addressed when
considering the validation of spectrophotometers:
DQ (Design Qualification) - the suitability of the
instrument for the required task
IQ (Installation Qualification)-showing that
the instrument complies with the manufacturers specification
PQ (Performance Qualification)-showing that the
instrument complies with established standards and practices
OQ (Operational Qualification)-providing documented
evidence for continued operability and data integrity.
Engineers from LAT are fully qualified to provide IQ and
OQ support. Instrument performance can be verified to manufacturers
default thresholds and all servicing and validations are backed
up by documentary evidence, highlighting the next time key
parameters should be independently checked.
CFR21 Part 11
Another important area that LAT can help with is the FDA
CFR 21 Part 11 requirements. These include security and data
audit tracking, appropriate operator access levels, details
of operator logins and logouts, and when each test is created,
changed, deleted or aborted. Audit trails must provide an
accurate history of data.