Validation services

GMP-compliant validations for cleanrooms, equipment, systems and processes

We perform individual validations or, alternatively, manage the maintenance of validity during the entire life cycle. If necessary, we consult and support our clients in the pre-planning phase of cleanrooms as well as equipment and system procurement. Validations are always performed by our qualified experts based on the requirements and instructions of both the client and the authorities.

Validity life cycle management

COMMISSIONING PHASE

Creation of user requirement
Risk assessments
Creation of validation plan and testing protocol
Performing the validation and reporting
Creation of SOP instructions and implementation training

OPERATION AND MAINTENANCE PHASE

Change management
Training and support
Variance control and CAPA process
Maintenance schedule
Regular assessments and revalidations

Validation includes four stages. Depending on the client’s needs, we can perform all the validation stages:

DESIGN QUALIFICATION (DQ): design inspection. The plans are in accordance with the requirements of the client and the authorities
INSTALLATION QUALIFICATION (IQ): installation inspection The installations are carried out according to the approved plans and requirements
OPERATIONAL QUALIFICATION (OQ): testing the functionalities
PERFORMANCE QUALIFICATION (PQ): testing the performance and the overall process

We offer comprehensive services for the validation of cleanrooms, equipment, commodities, computerized systems and processes. Learn more about our validation services for