The purpose of system validation is to ensure that computerized and automated systems operate as intended, handle data correctly, and meet GMP requirements throughout their lifecycle.
At the heart of system validation lies data integrity – a prerequisite for product, user, and patient safety. An unvalidated system can lead to inaccurate data, compromised quality, and non-compliance with regulatory standards.
Ask yourself these questions to assess the reliability of your systems:
These are the kinds of questions and challenges we help our clients solve every day. By applying a risk-based approach focused on patient safety, we help achieve strong data integrity, more efficient processes, and confidence that systems perform reliably under all conditions.
System validation applies to all automated and computerized systems whose performance affects product quality, user safety, or regulatory compliance.
Validations are performed for the following systems, among others:
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 thorough risk assessment and evaluation of the system’s impact on GMP compliance. These steps identify the critical functions and ensure that validation focuses on areas directly affecting product quality and safety.
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.
All stages of system validation are thoroughly documented to demonstrate compliance and data integrity. Documentation includes validation plans, testing protocols, test results, and any deviation reports.
Upon completion, a separate validation report is prepared, compiling all results and observations. The report includes all testing materials to verify that the system meets technical, quality, and regulatory requirements.
Detailed and traceable documentation supports audits, strengthens quality management, and ensures the long-term reliability of validated systems.
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.
By choosing Feicon, you gain a partner who offers:
Feicon ensures that validation is carried out correctly, on time, and in support of your business.
Typically before system commissioning or after significant changes. It should also be repeated periodically as part of lifecycle management — especially after software or interface updates.
Ideally during the design or procurement phase. Early involvement ensures that the system and its implementation are planned to meet validation requirements. Risk assessment at an early stage also saves time and costs later in the project.
Yes. We have extensive experience validating ERP, LIMS, SCADA, BMS, and FMS systems across various production and laboratory environments.
System validation includes the URS, validation plan, test protocols, test results, deviation reports, and the final validation report. Every stage is carefully documented to demonstrate full compliance.
Often yes. Validation requires deep understanding of GMP and GAMP 5, as well as the ability to assess system risk and criticality. External specialists ensure that the validation meets all regulatory requirements and withstands audits.
Yes. It is often carried out alongside equipment or cleanroom validation, allowing the entire environment to be verified as one compliant entity. This improves efficiency and coordination across the validation process.
"*" indicates required fields
"*" indicates required fields
