4Q Qualifications

Some laboratories that are UKAS, ISO17025, 21CFR Part 11 or GLP accredited, it is often required that the instrument supplier performs the 4Q qualification on the instrument annually
F-DGSi can offer you the delivery of a 4Q certificate to prove compliance on all its devices.
It is specific to each gas generator and this document validates the device, its installation, operation and performance on the device of the client on which it is connected.
This certificate is established by performing a series of tests on the gas generator using calibrated measuring devices with a certificate of calibration.

Conception Qualification (CQ)

Documented verification that the proposed design of facilities, systems and equipment is suitable for the purpose for which they are intended.

Instalation Qualification (IQ)

Documented verification that facilities, systems and equipment, as installed or modified, conform to the approved design and manufacturer’s recommendations.
An IQ includes a detailed list of equipment specifications prior to installation as well as product components

Operational Qualification (OQ)

  • Documented verification that facilities, systems and equipment, as installed or modified, operate as intended throughout the operating range.• Operational qualification demonstrates that the instrument is operating at its operational specification in the chosen environment.
  • The OQ F-DGSi procedure confirms that the product conforms to all relevant specifications published in the environment in which it will be used.
  • The process is fully documented. The data is reviewed, and a document is provided to assist with regulatory needs.

 

F-DGSi recommends performing an OQ in the following cases:

  • Installing or moving the generator from one place to another.
  • At regular intervals according to standard operating procedures in your laboratory.
  • Following major repairs.
  • Before the first use of a system already in place in a regulated test environment

Performance Qualification (PQ)

Documented verification that the facilities, systems and equipment, as designed, are able to operate efficiently and reproducibly, based on the approved operational method and product specification.