YOUR PROCESSES AND EQUIPMENT IN HIGH QUALITY

We are able to provide a wide range of services in the field of qualification / validation based on customer and regulatory requirements.
We provide our qualified personnel to support you in qualification and validation projects. In addition, we provide you with comprehensive advice regarding in-house concepts for qualification or validation.

YOUR GOALS - OUR STANDARDS

• Qualification / validation according to the valid regulations of FDA, EU, GxP, GAMP
• Use of regularly trained employees
• Extensive experience through numerous reference projects

OUR SERVICES

• Preparation of regulations and SOPs
• Preparation of the master plan
• Creation of qualification plans for DQ, IQ, OQ and PQ
• Creation of validation plans for process, cleaning and method validation
• Creation of risk analyses
• Creation of the traceability matrix
• Coordination of the qualification or validation activities on site
• Collecting and checking the required documents with regard to approval and completeness
• Performing IQ, OQ and PQ tests
• Preparation of the qualification reports
• Preparation of the qualification final report
• Performing supplier audits

SPECIALIZATION

In addition to qualification and validation activities for general pharmaceutical equipment, we are specialized in the following areas:
Computer System Validation (CSV)

• Cleaning validation
• Packaging systems - Track & Trace
• Package Units (PU)
• Monitoring systems
• Warehouses incl. data mapping
• Cold storage and deep-freeze rooms incl. data mapping