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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.

a.Consulting: Understand the product and process requirements in order to offer the most appropriate solution based upon built up knowledge, regulatory requirements as well as software, hardware and service possibilities (own and third party), including of course data integrity information. The whole is limited to Rotronic’s capabilities.

a.Project planning:Support a project approach timeframe to define the various possibilities concerning the deployment, installation, validation and go live.

b.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.

c.Demo application: A simple demo application is setup in order to get a real feel for the system and understand the possibilities available.

d.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.

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

a.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.

b.Heat mapping: Receive a documented mapping overview (including as found ISO-17025 traceable calibrations and recommendations) based upon USP-1079 guidelines to define the optimal location of the data loggers.

c.RSSI mapping: Wireless range mapping to ensure the appropriate location of the data loggers and gateways based around cost efficiency or redundancy to fulfil the radio frequency qualification.

d.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.

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

a.Customised engineering: The quality management system should enable continuous system improvements based on periodic review and evaluation, operational and performance data, and root-cause analysis of failures. All internal R&D is done around the GAMP©5 V-model. The customised engineering is limited to the scope of what Rotronic can provide.

b.Implementation of third party devices: Programming of the software as well as the RMS-Converter in order to add third party digital devices to the RMS system. Limited to the details within the third party protocol.

c.Script programming: Reduce time and efforts by carrying out automated OQ validations with the setup of the script function.

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.

a.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.

b.Integration - use the Rotronic team to carry out the additional and ongoing workloads and reduce fixed head count costs.

c.Factory acceptance test: Tests carried out within Rotronic to ensure the customer’s requirements are satisfied.

d.Site acceptance test: Tests carried out on the customer’s site to ensure the customer’s requirements are satisfied.

e.Retirement of current system: Retirement of the current system based upon the GAMP©5 guidelines.

f.Server installation: Virtual server setup and installed within the Rotronic certified data centre, linked together with the corresponding database ensuring perfect data integrity.

g.Software installation: Software installation on the customer’s server.

h.Device installation: Installation of the devices based upon the mapping recommendations.

i.System commissioning: Setup of the software and of the devices within the software to fulfil the FRS requirements.

j.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.

k.Operation - use the Rotronic team to carry out the additional and ongoing workloads and reduce fixed head count costs.

l.System Validation: RMS Validation Guide.

m.Onsite calibration: Calibration of the devices in-situ to ensure the accuracy of the devices as well as carrying out the check (ISO-17025 traceable calibration).

n.ISO-17025 calibration: Calibration of the devices in an ISO-17025 accredited laboratory.

o.Remote maintenance: Remote maintenance for a fast reaction.

p.Onsite maintenance: Onsite service should the remote maintenance not be sufficient. The onsite maintenance can include the following services:

i.Software:

ii.Hardware:

 

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.

q.Telephone support: Telephone support for a fast reaction.

r.Online training: Administrator and user based training supported with existing documentation and knowledge adapted to suit the trainees.

s.Onsite training: Administrator and user based training supported with existing documentation and knowledge adapted to suit the trainees.

t.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.

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

5.Modification and life time upgrades.

a.Customised engineering: The quality management system should enable continuous system improvements based on periodic review and evaluation, operational and performance data, and root-cause analysis of failures. All internal R&D is done around the GAMP©5 V-model. The customised engineering is limited to the scope of what Rotronic can provide.

b.Implementation of third party devices: programming of the software as well as the RMS-Converter in order to add third party digital devices to the RMS system. Limited to the details within the third party protocol.

c.Script programming: Reduce time and efforts by carrying out automated OQ validations with the setup of the script function.

d.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.

e.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.

6.Additional services

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

E-Mail: service-rh@rotronic.ch

Tel: +41 44 838 11 11