Rotronic AG Service Overview

The services offered by Rotronic AG are setup following the GAMP©5 life cycle approach to improve GxP compliance efficiency:

Based upon the user requirements, Rotronic can offer the most effective services for any RMS based system.

1. Consulting and concept development - make the most out of Rotronic’s worldwide knowledge and experience.

2. Hardware specification and selection - install products designed for monitoring.

3. Software adaptation - take advantage of the Rotronic research and development possibilities.

4. Application engineering: Based upon the product and process as well as the Rotronic system, a definition of the best solution is designed based upon the GAMP©5 guidelines.

Task	Quantity	Time
Software update	Based upon requirements/application	Up to 4 hours

1. Hardware:

Task	Quantity	Time
Firmware update	Based upon requirements/application	Up to 1 hour per device
Device exchange	Based upon requirements/application	Up to 30 minutes upon reception of device
Filter change	Based upon requirements/application	Up to 15 minutes per device
Battery change	Based upon requirements/application	Up to 15 minutes per device
Spot check	Based upon requirements/application	Up to 15 minutes per device
On site calibration	Based upon requirements/application	Up to 1 hour per set point
Implementation of a new device	Based upon requirements/application	Up to 1 hour per device
Revalidation of a measurement point	Based upon requirements/application	Based upon requirements/application
Validation of a measurement point	Based upon requirements/application	Based upon requirements/application
Qualification of the measurement chain (loop control)	Based upon requirements/application	Up to 15 minutes per device

All hardware service activities are to be discussed and confirmed by the customer in order that the devices be available and accessible at the moment of the service.

The maintenance periods are kept as short as possible. The afore mentioned maintenance periods and service interruptions are subject to any and every exception. Rotronic may change the definition of the maintenance periods and service interruptions in the interests of service quality and security at any time.

1. Telephone support: Telephone support for a fast reaction.
2. Online training: Administrator and user based training supported with existing documentation and knowledge adapted to suit the trainees.
3. Onsite training: Administrator and user based training supported with existing documentation and knowledge adapted to suit the trainees.
4. Risk analysis: A risk analysis of the system from the supplier point of view to ensure that risks are minimalised based upon the GAMP©5 guidelines.

5. Alarming: Receive all alarms via E-Mail, SMS or telephone call to be sure that no unconformities are missed!

6. Modification and life time upgrades.

7. Additional services

Please contact Rotronic directly should you have enquiries about any further service requirements.

E-Mail: [email protected]

Tel: +41 44 838 11 11