IQ - OQ - PQ

 
 
IQ OQ  

 
 
  Installation Qualification (IQ)

Operation Qualification (OP)

for every raytest product

 

 

 
 

Explanation
 
Installation and Operational Qualification (IQ/OQ) of production and analysis equipment are part of the formal qualification required by cGMP.

Our IQ/OQ documentation packages are developed according to FDA requirements and consist of professionally developed templates that facilitate equipment qualification.


Those of you who work in a regulated environment know the need to demonstrate to various auditors that your instruments are working correctly. This process is called qualification or validation. Qualification can be categorized into the following steps:

Installation Qualification (IQ) documents that the correct instrument was received and installed properly. IQ can be performed by the user or the vendor.

Operational Qualification (OQ) tests that the instrument meets specifications in the user environment. OQ can be performed by the user or the vendor.

Performance Qualification (PQ) tests that the system performs the selected application correctly. PQ must be performed by the user.
 

raytest offers IQ and OQ services for new installations, and periodic OQ services for existing equipment.

 
Our qualification protocol includes a visit to your site by a specially trained raytest technician, qualification of the instruments, and documentation of all the test results in a signed and dated test booklet. Prices for these services will vary by location and the number and types of instruments that are validated. Contact raytest for a quote.
 

Installation Qualification (IQ)

 
The raytest Installation Qualification contains a check of completeness of instrument installation and function control after installation onsite:
  • Procedure according to raytest IQ-documentation.
  • Generation of an IQ-certificate.
  • Instruments of other suppliers on request.
  • Required time approximately 1/2 day.
  • Incl. travel expenses inside of Germany.
  • Travel expenses outside of Germany on request.
 

Operation Qualification (OP)

 
The raytest Operation Qualification contains a check and certification of the system functionality according to test cases and acceptance criteria.
  • Procedure according to raytest OQ-documentation.
  • Generation of an OQ-a.
  • OQ of instruments from other suppliers on request.
  • Required time approximately 1 day.
  • Incl. travel expenses inside of Germany.
  • Travel expenses outside of Germany on request.
  • OQ requires a succesfully performed IQ.
 

Performance Qualification (PQ)

 
PQ will not be performed by raytest.
 
Detailed information

Please contact us
info@raytest.com; +49 7082 92 55 0