For pharmaceuticals and medical device manufacturers where health and safety is never compromised, Element Metech oﬀers calibration and validation services for measuring instruments and laboratory equipment to ensure regulatory compliance. Our GxP compliant services are performed to ensure the accuracy and uncertainty of all equipment in use, by well-documented calibration and validation, traceable to national and international standards.
Element Metech in Sweden and Denmark oﬀers a complete service range for validation. Our experienced team has a proven track record of delivering customized solutions meeting customer expectations and regulatory requirements
Our Validation team has broad knowledge and professional insights in:
Non-sterile validation of
Sterile validation of
Our trained experts always make sure that GxP-requirements, guidelines and special needs are being met.
Our trained experts can support with:
We also oﬀer additional GxP-compliant expertise, including support with preparation, approval and documentation of:
We provide rental of our wide and versatile range of GxP-qualifed validation equipment, which is always calibrated at our accredited calibration laboratories.
The equipment covers measurement of:
Measuring ranges and MPE-values depend on the equipment, but our validation equipment cover most needs.
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This service gives an internationally recognized calibration and fulfills the requirements for calibration according to ISO/IEC 17025. e.g to fulfill the requirements in QS 9000 and ISO/TS 164949. Read more
This service gives a traceable calibration that fulfills the requirements in ISO/IEC 17025, ISO 9000 and ISO10012. Read more