With over 2 years of computer systems validation experience, we work to create CSV processes that are based on FDA regulations and guidance, best practices, and the characteristics of the system being validated.

Computer System Validation (CSV) is a combination of Control System Validation (PLC + HMI, PLC+SCADA) and Software Validation (SCADA, Inspection System, Software).

It is the process of documenting that a computer system meets a set of defined system requirements.

The validation process is designed to provide a high degree of assurance that both new and existing computer systems will consistently fulfil their intended purpose by producing results which meet predetermined specifications and quality attributes – accuracy, reliability, consistent intended performance, and the ability to discern in valid or altered records is a critical requirement of electronic record compliance, as described in the FDA 21 CFR 11.10(a) and EMA Annex11, Section4.

Computer system validation requires a comprehensive set of both static and dynamic testing activities that must be conducted throughout the Software Document Life Cycle (SDLC)

At Skandanana, we are experts in risk identification and management along with regulatory compliance. As such, we understand that computer system validation is not a “one size fits all” process. With over 2 years of validation experience, we work to create CSV processes that are based on the latest FDA regulations and guidance (GAMP®5: A Risk-Based Approach to Compliant GxP Computerized Systems), best practices, and the characteristics of the system being validated. Our CSV processes typically involve:

Computer system validation requires a comprehensive set of both static and dynamic testing activities that must be conducted throughout the Software Document Life Cycle (SDLC)

Our CSV processes typically involve:

Validation Approach

• System Level Impact Assessment– to determine if the system being reviewed requires computer system validation activity.
• Validation Plan– defines what will be validated and the approach for maintaining validation status
• User Requirement Specifications– clearly defines what the user needs from the software and how they will use it
• Functional Design specifications– clearly defines how the software needs to work and look to meet the user needs
• GAP Assessment – clearly defines to the space between “where we are” (the present state) and “where we want to be” (the target state
• Risk Assessment– identify the potential risks associated with the implementation and usage of the system
• Installation Qualification (IQ) Scripts and Results– provide confirmation that the software or system is installed and setup according to the Design Specification
• Operational Qualification (OQ) Scripts and Results– test cases for checking that system referred to as Functional Testing or System Testing
• Performance Qualification (PQ) Scripts and Results– test cases for checking that the system will meet the users’ needs and is suitable for their intended use, as defined in the User Requirements Specification
• Traceability Matrix – provide the relationship between the requirements defined in the URS and Qualification tests
• Summary Report – a review of all activities and documents against the Validation Plan

Our computer system validation professionals provide you with a best practice CSV methodology along with the peace of mind that comes from knowing your CSV documentation has been produced by experts