Certificate of Analysis
With every shipment, there will be a certificate of analysis attached. This document is to certify that Q-tag AG has tested and accepted the specified items according to the thereon named technical specifications. The used testing equipment is certified in harmony to national SCS standards.
The sampling lot acceptance tests after production as well as the functional tests of each item were made in accordance to the ISO 9001 quality system of Q-tag AG and Berlinger & Co. AG
FDA 21 CFR Part 11
The IT software applications Berlinger provides are validated and meet the requirements of the FDA 21 CFR Part 11 regulations relating to electronically stored data and signatures.
All the reference devices from Berlinger & Co AG used for critical measurements must meet NIST (National Institute of Standards and Technology) standards. The standards state that all reference devices must be routinely calibrated by qualified employees.
The calibration of these devices must be verifiable. Berlinger & Co AG employees must be specially trained to perform this function. Berlinger & Co AG has a documented planning, measurement and test device procedure for handling the NIST requirements. This plan is checked regularly in accordance with our ISO 9001 certification.
Berlinger & Co. AG's products are CE-certified to ensure their acceptance within the EU. Our products comply with the most comprehensive regulations — the EMC (Electromagnetic Compatibility) Directive. This means our products function correctly even in environments which are exposed to electronic emissions, such as work around forklifts, radios, cell phones, RF, EMI and ESD, CBs and other electronic equipment.
Further standards our devices comply with
ASTM 2500, 21 CFR Part 820, ICH Q8/Q9, ANSI/IEEE 829/830/1008, EN 12830, 2011/65/EN (RoHS 2), 2012/19/EU (WEEE), 2004/108/EC EMC, EN 61000-4-2/6-2/6-4 EMC, EN/IEC 60529 IP protected classes, IATA Regulations