System Validation

Validations are performed for the following systems, among others:

• Computerized systems (ERP, FMS, BMS)
• Pipe transfer systems
• Purified water systems (PW, WFI)
• Ventilation systems (HVAC)
• Clean-in-place systems
• Medical gases: Oxygen, PSA medical oxygen generators, Nitrogen, Compressed air

System validation is based on the EU GMP, Annex 11, Computerised Systems requirement, and is performed based on an approved user requirement (URS, User Requirements Specification) and validation plan, following the GAMP 5 (Good Automated Manufacturing Practice) guidelines.

Computerized systems also require a risk assessment and an assessment of GMP effectiveness.

System validation is performed in four stages:

1. Design Qualification (DQ)
A design inspection, which is carried out when the system or part of it is tailored to client needs. DQ ensures that all user requirements have been taken into account in the design.

2. Installation Qualification (IQ)
An installation inspection, which verifies the correctness of the installations and compliance with the requirements. IQ ensures the physical installation of the system as well as the installation of software, equipment and system connections.

3. Operational Qualification (OQ)
Functional testing, which verifies the correctness and compliance of the system’s basic functions. OQ ensures the functionality related to system control, administration, security, data processing, and equipment and system connections. The procedures and instructions related to the maintenance of the system’s validity and the management of the entire life cycle are also verified in the OQ phase.

4. Performance Qualification (PQ)
Performance testing, where system performance and functionality are checked as part of the overall process. PQ ensures system capacity, data flow, the absence of disruptions and general functionality in the final installation environment and configuration.

The performance of the system validation is documented with a separate validation report, to which the material of the performed validation testing is attached.

We offer our clients solid system validation expertise. If necessary, we prepare and get approval for the user requirement, prepare a validation testing protocol, perform validation testing, and prepare and get approval for a validation report. If necessary, we also assist our clients in system acquisition, design, validity maintenance and life cycle management.

In terms of system validations, we have over twenty years of extensive experience in the following systems, among others: enterprise resource planning systems (ERP), information systems (LIMS), process automation systems (SCADA), building management systems (BMS), condition monitoring systems (FMS).

Please feel free to contact us if you have any questions about system validations.