Qualification and validation

Qualification provides convincing proof of the flawless functionality of individual installations and systems. This contrasts with validation, which ensures that precisely documented evidence is provided for processes with a direct influence on product quality. It is particularly in the pharmaceutical and chemical industries that qualification and validation are indispensable components of the manufacturing process.

Our team of experts prepares comprehensive documentation for both old and new systems, in line with the AQIPTECH quality management guidelines or the specific requirements of our clients. We undertake qualifications and validations in accordance with the Good Manufacturing Practice (GMP) guidelines and are also at the disposal of third-party companies.

Our services at a glance:

Comprehensive support for your qualification process, from start to finish or in certain areas
Specialist advice for the implementation of qualification projects
Support in the creation of user requirement specifications (URS) and functional specifications in collaboration with the supplier
Preparation of qualification and decommissioning plans
Design qualifications (DQ) and installation qualifications (IQ)
Functional qualifications (OQ) and re-qualifications for modifications to qualified systems or old systems
Review of qualification documents for completeness and formal requirements
Support in creating SOPs (Standard Operating Procedures)
Creation of work instructions and operating manuals
Development of training plans and implementation of training courses
Support in planning and implementing process and product validations
Validation of computerised systems as per GAMP

Put your trust in our expertise so that you can efficiently qualify and validate your systems to meet the highest quality standards.

Refererences / Case studies

What we can achieve

Check out our inspiring case studies and impressive references for an insight into our successful projects.