|
Qualification Package
Sci-Tek Instruments understand the requirement to comply with regulatory bodies such as FDA and MHRA to ensure your instrumentation is performing within the limits specified by the manufacturer.
Sci-Tek Instruments can perform a series of operational, performance and instrument qualifications** on each module or as a system to ensure compliance to the limits specified by the manufacturer. Usually, qualification work is carried out in conjunction with the maintenance visits detailed above however, we can perform them independently.
**Qualification content defined by the SOP (standard operating procedures) for each particular module. Tests can be modified from OEM original to suit customer specific tolerances.
All tests are CFR 21 Part 11 compliant and traceable standards are used.
All our work is carried out to stringent SOPs
|
