Qualification Services

    For customers working in a cGxP regulated environment, quality and traceability of results have highest priority. CAMAG supports these efforts with highly reliable products and qualification services. The customer’s compliance strategy is optimally supported with CAMAG's Installation Qualification (IQ) and Operation Qualification (OQ).

Installation Qualification (IQ)

This qualification is performed at the site and time of installation. It documents that all key aspects of the installation comply with the manufacturer’s specifications, codes, safety and design parameters.

Operation Qualification (OQ)

This qualification is performed subsequent to installation and is repeated at certain intervals recommended by the manufacturer or defined by the customer. It documents that all modules of the equipment perform consistently throughout the specified operating ranges.

Performance Qualification (PQ)

PQ is performed to ascertain that the instrument (system) is suitable to perform a specific analytical task as part of the customer specific process. PQ is an ongoing task with the customer’s samples and procedures including preventive maintenance and regular tests, such as system suitability and quality control analyses with creation of QC-charts. For computer systems it also includes regular data backup, virus checks and change control procedures. PQ is the responsibility of the customer and has to be performed by the customer, with customer specific SOPs based on the analytical task and according the customer’s quality management system. On request, such PQs can be established with the assistance of qualified CAMAG staff.

CAMAG Design Qualification (DQ)

This qualification verifies that the rigorous specifications and design review methods defined in the Quality Management System of the manufacturer have been followed. CAMAG’s ISO 9001:2018 certified Quality Management System ascertains planned testing procedures, error reporting and controlled updating of documents. Compliance is documented, e.g. by the "Declaration of Conformity" supplied with specific products.

More information

Do not hesitate to contact your local distributor for more information on CAMAG qualification services