AnaLight® Instrument Validation
Farfield AnaLight® Qualification is designed to meet the support requirements of the pharmaceutical, fine chemical and biotechnology industries across the full system validation process. The Equipment Qualification meets the regulatory expectations of our worldwide customers working to GLP, GALP and cGMP standards, including:
- IQ/OQ - Installation Qualification/Operational Qualification. Procedures and training are carried out by qualified Farfield service personnel on installation of the AnaLight® system in its operating environment.
- PQ - Performance Qualification. Designed to verify that the AnaLight® system performs to operating specifications in the field, enabling regular verification of system performance under the conditions used by the customer.
- MQ - Maintenance Qualification. Providing preventative maintenance to all GxP standards and a re-qualification service, ensuring correct function and maintenance of the AnaLight® system for its entire lifetime.
Farfield also provides quality assured calibration AnaKits™ designed to ensure the correct functions of the AnaLight® system. Furthermore, during Performance Qualification, all measurements are performed with calibration standards and reagents that are fully traceable* to National and International Standards.
This Equipment Qualification offering makes Farfield's AnaLight® product range the first fully validated instruments for measuring molecular structure and function simultaneously and the first instruments offering structure and function measurements fully traceable* to National and International standards.
*Traceability means that the result of a measurement, no matter where it is made, can be related to a national or international measurement standard, and that this relationship is documented. Without reference to these primary standards, equipment would only show changes and repeat indefinable indications, i.e. the measurements would be just 'some kind of' values. The concept of traceability is important because it enables the comparison of the accuracy of measurements worldwide according to a standardised procedure for estimating measurement uncertainty, and is pivotal to global collaborative research across all industrial sectors.
Farfield's instrument qualification service is presently managed directly from Farfield's head office in the United Kingdom. For more details or information, please contact service@farfield-group.com.