Validation and Qualification in Laboratory Analytics
The qualification of devices and systems is an essential element of validation processes. As a manufacturer of laboratory instruments, we at A.KRÜSS meet the enormous demand for qualification services with a comprehensive concept.
Qualification: Our four-stage process
We work together with you, our customers, hand in hand and offer comprehensive support throughout the entire qualification process.
Qualification in accordance with valid guidelines, standards and laws
Our four-stage qualification is intended to save you costs, resources and time in the process. Our specialists can draw on many years of experience in the qualification of measuring instruments and are fully familiar with the current applicable regulatory requirements of the prevailing directives, standards and laws. Below is a selection of the requirements that are important to us:
- cGMP Rules for Medical Devices
- Good Automated Manufacturing Practice (GAMP) Guidelines
- FDA-compliant qualification of systems (21 CFR Part 11)
- Requirements of pharmacopoeias or USP
- DAkkS Guidelines
- Based on the requirements of DIN EN ISO 17025
A.KRÜSS qualification with expertise at your side
We bring along the knowledge about the devices and integrate it into the manufacturing processes of our customers. Our number one priority: We want to ensure that you can carry out your quality control effectively and reliably. The devices that we optimally configure for you should give you confidence in the quality and significance of your daily analysis results.
- Qualification with A.KRÜSS is achieved by reducing the expenditure to a justifiable level, without mountains of paper, with easy-to-understand documents.
- The documents can be requested in advance from us for viewing.
- We work with you using the necessary specialist tools and measuring equipment (traceable standards) and have extensive expertise in test equipment management.
- We know that today’s digital devices are subject to stringent testing in terms of data integrity. This is why we initialise the proper device firmware configuration for you and the correct operating competence so that your software applications always fit perfectly.
- We work with electronic signatures, the uniqueness of the combination of user ID and password.
- The data documentation is flanked by an audit trail concept.
Qualification - adapted to your needs
We understand the different needs of our customers. Various qualification models exist for highly regulated areas and for laboratories with standard requirements:
- This standard solution is a GMP/GLP-compliant qualification, with IQ and OQ service on site and including the compilation of all the necessary test reports and certificates. A. KRÜSS also provides the necessary certified test equipment, measurement, control and specialist tools for qualification.
Standard qualification including PharmaKit:
- We recommend the advanced solution with the PharmaKit, if customer devices have to meet the requirements in highly regulated areas. If your devices require additional certification and evaluation of compliance with GAMP5, GMP, USP1058 and 21 CFR Part 11.
- This qualification contains a preliminary consultation and an examination, commenting and conformity assessment of the fixed written DQ requirements in your customer specification. Apart from the standard qualification services, the PharmaKit also includes many necessary additional services, for example risk-based documentation, a check list for software requirements or SOP support on site.
You need our support for qualification services?
Do you want to know more? Do not hesitate to contact us. Our qualification professionals will be happy to answer your questions promptly and competently.
Phone 040 – 514 317-0
Mo.-Fr. 09:00 Uhr bis 17:00 Uhr