In a regulated environment documented verification that your instruments are installed and functioning within their operational specifications is key. However, the process can be complex and time-consuming.
Our portfolio of qualification services includes Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for Leica Microsystems instruments, as well as software qualification.
Who would be better suited to support you with compliance services than the experts who develop and support the instruments you use? Qualification Services from Leica Microsystems are carried out by trained and certified service engineers who partners with you to ensure your Installation Qualification and Operational Qualification are in line with the requirements of our overall system validation.
- Order and system verification to prove that the instrumentation ordered was received and fully documented
- Installation verification to prove the installation meets specification
- Customer training verification to prove customers are trained on the basic operation and use per Leica’s specifications
- Verification of hardware to verify it functions according to Leica specifications upon installation
- Operational verification to prove the instrument meets specified operational criteria
Installation Qualification (IQ)
Operational Qualification (OQ)
- After installation
- After periodic maintenance
- After any service intervention that is critical to the instrument’s performance
- After relocation of the instrument and re-installation
- After an upgrade or modification that affects functionality or performance of the instrument (hard-/software upgrade)
- Before the instrument is integrated in a regulated process or procedure