Installation, Operation and Performance Qualification of a Thermoguard Installation Thermoguard
Qualification in Accordance with GMP To operate Thermoguard hardware and software within a regulated environment in accordance with the guidelines of Good Manufacturing Practice, GMP, harmonized by the Pharmaceutical Inspection Convention, some formal qualifying steps are required. Qualifications according to GMP DQ: Design Qualification IQ: Installation Qualification OQ: Operational Qualification PQ: Performance Qualification The system owner should document his user requirement specifications, URS, for the monitoring system in a Design Qualification document. Thermoguard provides a template DQ document with a full set of requirements. A documented check of the installation (Installation Qualification) and an assessment of the operation and performance (Operational and Performance Qualification) of the system should follow. Due to the technical nature of the system, the operational and performance check are combined. The procedures described below should be run with results within given limits before using the installation. Execution and success of these tests should be documented using this form and approved by the relevant equipment owner and qualified person according to GMP. Installation Qualification The installation qualification is proved by the documentation of the hardware and software installation. The documentation qualifications includes the device list of all installed temperature and humidity sensors as well as the configuration list of the program. The device list can be achieved by exporting the sensor inventory by using the context menu under "Configuration/Sensor Configuration/export sensor inventory". The configuration list is obtained by printing the file "TGuard.ini" from the installation directory. Thermoguard Installation, Operation and Performance Qualification Page 2 of 4 Subject to changes.
Operational Qualification The Operational qualification consists of two tests to check the functionality of the software as well as the sensor controllers and sensors: Test 1: After proper installing of the Thermoguard software (including the license file and complete configuration of all the sensor controllers and sensors) the function "Poll all" is used to check the communication between the software and every sensor. The result of the "Poll all" function is displayed in the "Activity log" window and stored in the log file. The correct function is proved by printing the log file. Acceptance criteria: The log window and the log file may not contain an error. The log file should be printed and signed by the equipment owner and qualified person according to GMP. Test 2: Test the alarm functions mail and SMS by using the button "send test mail(s)". A printout of the delivered mail is used as a proof of the successful alarm function. Acceptance criteria: Both test mail and SMS should be delivered successfully. Thermoguard Installation, Operation and Performance Qualification Page 3 of 4 Subject to changes.
Performance Qualification Thermoguard network monitoring can be classified according to the United States Pharmacopoeia (USP), Chapter 1058, as Class B equipment with a simplified performance qualification by performing a calibration. Calibration of Thermoguard network sensors can be done in several ways: Option 1: Traceable calibration certificates for temperature and humidity sensors show the correct function of these sensors. Thermoguard sensorcontrollers have a precise internal reference resistor of known accuracy and require no external calibration. Option 2: Calibration of temperature sensors including the sensorcontroller at 0.01 degree Celsius with an ice/water mixture (triple point according to the international temperature scale ITS 90). Calibration of digital humidity sensors using humidity reference salt cells according to NIST. Option 3: Running a comparative measuring during a defined period of time, using a traceable calibrated reference thermometer (e.g., Thermoguard temperature calibration set TGCSTx) respective a traceable calibrated moisture meter (such as a Thermoguard humidity calibration set TGCSrF). Note: Since pressure sensors (e.g. Thermoguard HM1) are difficult to calibrate in the field, pressure readings might be marked as uncalibrated and should be used for informational purposes only. Acceptance criteria: Measurement results should be within the specifications of the sensors and controllers (given by data sheets or norms), independent from measuring principle. Note The installation, operation and performance qualification tests do not include tests for a full qualification of all functions of the computer, data security, access protection or other requirements according the IT within a regulated environment. These requirements should be addressed in a framework of an overall, enterprise-wide IT policy. Release of the Installation After successfully finishing of all qualifying steps, the installation should be released for usage with date and signature by the equipment owner and qualified person according to GMP. Thermoguard Installation, Operation and Performance Qualification Page 4 of 4 Subject to changes.
Checklist: Qualification Documents Design qualification: User requirement specifications documented and released? Design qualification: Data sheets added to documentation? Installation qualification: Equipment binder prepared and equipment owner trained? Installation qualification: Device list exported, printed, marked with date and signed? Installation qualification: Configuration list ("TGuard.ini") printed, marked with date and signed? Operational qualification: All sensors successfully polled? Corresponding log file printed, marked with date and signed? Operational qualification: Test mail successfully send, printed, marked with date and signed? Performance qualification: All temperature and humidity sensors successfully and traceable calibrated? Thermoguard Installation, Operation and Performance Qualification Annex Subject to changes
Identification of the Thermoguard Installation Owner of the installation: Location of the installation: Date of Installation: Equipment owner: Release of the Thermoguard Installation The Thermoguard Installation described above fulfills all requirements of the installation, operation and performance qualification. Therefore, the installation is released for its intended use. Prepared: Date Signature Approved: Date Signature Released: Date Signature Thermoguard Installation, Operation and Performance Qualification Annex Subject to changes