For customers working in a cGMP regulated environment, CAMAG offers Installation Qualification (IQ) and Operation Qualification (OQ) as service.
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.
In order to qualify for an IQ Certificate, this procedure is to be performed by a Product Specialist, approved by CAMAG.
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.
The initial OQ is performed by the person responsible for the IQ at installation. In order to qualify for an OQ Certificate, this procedure is to be performed by a Product Specialist, approved by CAMAG.
Repetitive OQ’s can be performed by a system user well aquatinted with the system, following guidelines issued by CAMAG. On request of the customer, such OQ’s can be performed by a Product Specialist or Service Engineer approved by CAMAG, against a fee or within a service contract.
Performance Qualification (PQ)
PQ is performed to ascertain that the instrument (system) is suitable to perform a specific analytical task as part of the manufacturing process. PQ is an on-going task with the customers 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 can thus only be performed by the user himself who also has to create the SOP’s based on the analytical task, the CAMAG OQ procedure, the different instrument manuals and the customer's QC requirements. On request, such PQ’s can be established with the assistance of qualified CAMAG staff. Ask for a quotation.
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 (DE) / ISO 9001 (EN) certified Quality Management System ascertains planned testing procedures, error reporting and controlled updating of documents. Compliance is documented, e.g. by the "Declaration of System Validation" and "Declaration of Conformity" supplied with specific products.
The Design Qualification is sometimes used in a different meaning. One common misunderstanding is to use DQ for "suitability of the laboratory equipment". To make sure the laboratory is equipped with the necessary supporting equipment etc., we can supply a paper on "Environmental Specifications" (example). Another common mistake is to use DQ for System Suitability Test which in fact is handled by the Performance Qualification (PQ).
Please notice the following if you are interested in the CAMAG IQ/OQ services
- Ask for a specific quotation including IQ/OQ for new CAMAG instruments to be qualified.
- If the IQ/OQ is to be performed at a later stage than the first installation then the instrument(s) will have to be serviced and if necessary updated to the latest specification. This will cause additional costs.
- In order to qualify certain instruments (e.g. Linomat 5, Automatic TLC Sampler 4) a qualified CAMAG TLC Scanner 3 must be available. For qualification of other instruments (Reprostar 3, VideoStore, TLC Scanner 4) you may manufacture and qualify the necessary test object locally using a qualified CAMAG instrument or purchase the qualified object from CAMAG.
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