• Validation

    • Is an Operation Qualification (OQ) included in the Preventive Maintenance (PM) visit?
    • Gyros Preventive Maintenance (PM) protocol is intended to demonstrate that the instrument remains in the same operational status as during installation or validation. Preventive Maintenance should be executed at least once a year in order to ensure that all parts perform to original specifications and to maintain the instrument‘s validated state. Additionally, Gyros recommends that you perform system functional tests such as Gyrolab Functionality Check on a regular basis in order to monitor system performance. In the IO/OQ binder delivered from Gyros, there is an index tab intended for archiving PM protocols as addendums to IQ/OQ. This can be used if other routines for archiving the PM protocol are not available. The protocol itself is signed by the end user representative and the Field Service Engineer (FSE) after completion of the PM. Every step of the PM is signed by the FSE during the execution of the PM.

    • Gyrolab software is designed to support compliance to 21 CFR Part 11. Can you give examples of regulatory features?
    • • All software has been developed and validated according to Gyros Quality Management system prior to launch and processes for IQ/OQ and guidance for PQ are available. • Software is maintained according to Gyros Quality Management system including well defined processes for customer feedback as well as non-conformity handling. • Use of appropriate controls over systems documentation by quality system. • Audit trail: all changes in the software and instrument settings are recorded. • Secure data transfer and data storage. • Accurate and complete electronic copies of records. • Records are printable, e.g. results, Gyrolab methods. • Protection of records to ensure their accuracy and retrieval throughout the records retention period. • Use of authority checks. • System access only by authorized individuals. • Analysis management controlled through user levels. • Strict policies related to user password handling. • Password storage is encrypted. • Use of electronic signature (sign off data analysis) with two unique identifications (user and password). • Operational system checks enforce correct data input and operational sequence of steps and events of experiments. • Template methods enable control of each process and analysis step in an immunoassay workflow without the need for user intervention. • Use of device checks for data input e.g. CD-tag reader (RFID). • Users are trained by certified Gyros personnel.