The Rotronic Monitoring System is designed for GxP applications and as of such, Rotronic offer the corresponding services:
1) Project Management
The Rotronic Monitoring System (RMS) is a hardware and software solution adjustable to your requirements for a continuous monitoring system. The complete system conforms to GAMP5, Rotronic is well aware that our support is crucial to your project, so we offer a complete solution. From the user requirement specifications to the IQ/OP/PQ with our detailed documentation finishing off with tailor made training for your employees.
Furthermore the RMS software is delivered as a GAMP software category 4 system, but based upon your URS can also be upgraded to a category 5 system. For the validation of a category 5 software, more time and effort is required, but Rotronic will guide you along the way. Our main goal is to fully understand your requirements and deliver the best continuous monitoring system for you and your company.
2) Area Qualification – Temperature and Relative Humidity Mapping
- Warehouses and other storage areas.
- Climatic chambers
- Temperature and relative humidity generators.
3) Acceptance Tests
- Factory Acceptance Tests.
- Site Acceptance Tests.
- Traceable calibration for temperature, relative humidity and differential pressure.
- ISO 17025 certified calibration for temperature and relative humidity.
The software is validatable, so time to validate your continuous monitoring system. If you did the URS with the Rotronic documentation, then we can also offer the rest of the validation documentation, the validation master plan, the risk assessment, the functional requirement specifications, the configuration specification, the requirement traceability matrix, the validation script specification, the installation qualification, the operation qualification and the performance qualification of course followed by your tailor made training.
This validation model is based upon the GAMP5 standard and is recognised throughout the pharmaceutical world. The entire validation will prove that your system replies to your URS. Even if you didn't use the Rotronic URS, you can still use the Rotronic documentation as guidelines. With our team of trained professionals, Rotronic can carry out the validation of your system partially or fully if required.
6) RMS System Training:
- Admin training.
- User training.
- Rotronic also offer training for calibration, relative humidity fundamentals…
7) Maintenance and Support:
- Service Level Agreements on the software.
- Maintenance contracts for the hardware (calibration, battery changes, filter changes…)
Please be aware that services in each Rotronic/PST location may vary.
Any questions, contact us today
Rotronic has designed a functional description document explaining each and every function of the RMS software. This description will help you create your own URS, but it might also help you adapt the one you already have striving to provide the best risk based approach to compliant GxP computerised systems. Don't know exactly how to build up your URS? No need to worry, Rotronic have the knowledge and documentation required to help support you in any case. The continuous monitoring system RMS is a very flexible solution both on the hardware and the software side (R&D and production in the Headquarters in Switzerland). You have a problem, let us work together to give you the perfect solution. A personal discussion is of the upmost importance though, only when speaking to you can we really understand your requirements for a continuous monitoring system!
After fully understanding your requirements, a project is setup at Rotronic. Each and every step is listed, costs evaluated and an initial time line defined. A crucial point is software adaptations, any adaptions are follow a stringent testing process within Rotronic, so project timing is a key to a successful roll out of your continuous monitoring project. Rotronic has the possibility to carry out the complete monitoring system project, from the heat mapping of the various areas to the physical installation of the devices. Internally, the project team needs to understand your requirements in order to deliver your solution based upon your time line. Our main aim is an optimised communication based upon information transfer to the entire team: sales, product management, inside sales, after sales, production and R&D are all involved already in this initial process.
Rotronic will give you an initial quotation based upon your URS and the project planning. This initial quotation is rarely the final quotation, but a ball park figure that will help you to get a feeling for the costs of a project. Products will be added and removed, services will be adapted… The initial quotation will help you get a feel for the market and already an understanding of what working with Rotronic is like. We are more than happy to invest time in a project, so that you get the best continuous monitoring solution possible!
Pricing and promises in hand, we consider it important that customers actually try out the RMS. Be it via our cloud solution or our server software, our engineering team will offer you a solution based upon your requirements. When you start to play with the software, very quickly, thanks to its simple and effective design, you can work your way through the different functions and get a real understanding for what the system can offer. With just a few measurement points, you can already get a feeling for what is going on in the various locations that you monitor. Increase of CO2, people are in the room, a temperature decrease might mean that the heating has been cut off, the lux increase, the sun is coming up… Everything of course can be verified by adding an IP camera next to the measurement point to confirm what you are seeing. You can get a feel for the alarming functions, an overview of how the audit trail actually works and what data you can extract from the system! We will support for the optimal installation of your demonstration, you need to test it to understand the flexibility of what Rotronic can offer you. After seeing the demo, new ideas will appear and will help you monitor exactly what you want and how you want to do it.
You now understand that the sky is not the limit with our universal RMS. You've had new ideas, seen new potential and have accordingly updated your URS. Rotronic has been with you throughout this process and can now give you a tailor made quotation responding to your exact detailed requirements for a continuous monitoring system.
Of course, a market comparison is necessary! The flexibility and quality of RMS, the professionalism of our team and the complete package that we can offer will be sure to make Rotronic a very competitive partner for your project. Need more details from our side, don't hesitate to give us a call. Remember, we are FDA 21 CFR Part 11 and GAMP 5 conform for the most demanding applications, but we can also help you with smaller projects where these regulations are not required.
Congratulations on choosing to partner with Rotronic on your project! After a review of the project planning and time lines, we can start with the physical installation of the devices, the setup of the software and SQL database on your server, the configuration of the software and the hardware (this is as well something that you can choose to do on your own, we are always happy to offer a helping hand). The heat mapping or the wireless signal mapping can both be carried out with the helping hand of Rotronic should this be a necessity.
The software is validatable, so time to validate your continuous monitoring system. If you did the URS with the Rotronic documentation, then we can also offer the rest of the validation documentation, the validation master plan, the risk assessment, the functional requirement specifications, the configuration specification, the requirement traceability matrix, the validation script specification, the installation qualification, the operation qualification and the performance qualification of course followed by your tailor made training. This validation model is based upon the GAMP5 standard and is recognised throughout the pharmaceutical world. The entire validation will prove that your system replies to your URS. Even if you didn't use the Rotronic URS, you can still use the Rotronic documentation as guidelines. With our team of trained professionals, Rotronic can carry out the validation of your system partially or fully if required.
Who better to receive support from but from the manufacturer? Maintaining your system is crucial for the running of your processes. Rotronic offers packages from ISO-17025 and ISO-9001 calibrations only (temperature, relative humidity, dew point, differential pressure) to hardware and software maintenance contracts, build around your requirements. The software is also setup in a way that it makes hardware changes ever so simple and effective. Like the system our support is already very flexible!