Consultation, Validation, Calibration

GxP consultation

We place our knowledge at your disposal.

With our consulting services in GxP, we support you from project planning (URS) to implementation and testing of your system. This ensures an optimal and efficient design.

The individuality of your application may require a variety of function-specific settings and measurement systems. Rotronic is one of the leading suppliers in the world for humidity and temperature measurement equipment. Benefit from our know-how and let our application engineers design the optimal measuring system for you.

Validation & qualification

FDA CFR 21 Part 11 is not just a title.

Validation is a process for creating documents that show that a procedure, process or activity maintains the desired level of compliance at all stages.

Missing information and poorly specified or inadequately tested systems represent a risk and can lead to high maintenance costs and losses in productivity.

Rotronic supports you in all areas relating to validation:

1. Development of SOP for system validation 2. Preparation of project-related validation plans and risk analyses 3. Preparation of IQ/OQ-PQ documents 4. Preparation of validation reports 5. And others

Risk Management / Design Review Change and Configuration Management

V-model (validation)

Your benefits

• Competence in validation directly from the manufacturer • FDA/GAMP-compliant systems

Queries

support-rh@rotronic.ch

On-site calibration ISO 9001

Benefit from our mobile calibration facilities.

You do not like long downtimes of your measuring equipment/test equipment? Then why not take advantage of our offer to calibrate your measuring equipment at your premises. Our calibration engineers will come to your production line/facilities/premises with portable humidity & temperature generators and calibrate your measuring equipment with minimum downtime.

If you do not wish to have external work carried out on your production lines/facilities/premises directly due to its disruptive nature, we will park in front of your company and calibrate your measuring and testing equipment in our air-conditioned calibration mobile. For further information, please go to: www.kalibriermobil.com

ISO 9001 calibration (laboratory)

Customers have relied on our know-how in calibration since 1965.

In our factory calibration laboratory, we operate systems according to standardized procedures, documented in accordance with ISO 9001, enabling us to ensure top and consistent calibration quality and to guarantee same to our customers. Ongoing communication between the SCS laboratory (ISO 17025) and the calibration team for factory calibrations increases the knowledge of both teams and benefits the customer!

Further, as manufacturer of the internationally known humidity & temperature generator HygroGen HG2, we are able to offer our experience not only to end customers but also to competitors as users of our know-how and equipment.

ISO 17025 calibration

The Swiss Rotronic ISO 17025 laboratory has existed since 1995 benefit from our experience.

In our SCS 0065 accredited calibration laboratory, we offer the highest and traceable accuracy for your temperature and relative humidity measurement devices. The accuracy of measuring instruments can only be confirmed by regular calibration. Rotronic operates its state-of-the-art calibration laboratory (ISO 17025 accredited) with efficiency and the highest quality.

All our references are traceable to the national standard with excellent measurement uncertainty. We calibrate Rotronic instruments as well as third-party products.

Accredited calibration laboratories worldwide • Switzerland: SCS 0065 calibration laboratory

ISO 17025 accredited by SAS and traceable to the national standard • Germany: SCS 0065 calibration laboratory

ISO 17025 accredited by SAS and traceable to the national standard. • England: UKAS 0766 calibration laboratory

ISO 17025 accredited by UKAS and traceable to NPL • USA: Cert. no. 5622.01 calibration laboratory

ISO 17025 accredited by A2LA and traceable to NIST International unit

National standard

Accredited body

Factory calibration

Consumer SI unit

METAS

SCS 0065

Consumer

Calibration hierarchy (e.g. Switzerland)

Your benefits

• Higher confidence and recognition of calibration certificates by auditors (ISO 17025) • Highly accurate SCS calibration (ISO 17025) • Expedited calibration available

Queries

calibration@rotronic.ch