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