Subject – Computerized System Validation (CSV)
One of the largest preclinical contract research organizations in Europe, headquartered in Poland, provides effective drug discovery support to its clients, ranging from target validation to clinical candidate selection.
The client sought to validate two modules within a new system, P4Labs, developed to meet specific company requirements (GAMP 5 category). The modules included:
- Document Repository for electronic documentation flow and personnel training,
- Sample Management for material flow management in warehouses and laboratories.
Facing the challenge of ensuring GMP and Annex 11 compliance within tight deadlines, the client engaged eConsulting for Computerized System Validation (CSV) services. Drawing on expertise and prior collaborations, eConsulting initiated a comprehensive consultation process.
Scope of work – Computerized System Validation (CSV)
At the project outset, clear objectives, scope, and a detailed timeline were established. The project encompassed two primary phases:
- Qualification of IT Infrastructure: Despite theoretical dispensability, qualifying the infrastructure was deemed necessary to ensure the validated system’s integrity. This phase yielded seven critical documents: User Requirement Specifications (URS), Quality Plan (QP), Functional Risk Assessment (FRA), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Quality Review (QR), and Traceability Matrix (TM), along with documentation for deviations.
In this segment, all deliverables needed to be created with know-how pieces of information from the client’s IT department.
- Validation of the P4Lab System: Simultaneously, validation of the P4Lab system commenced, involving a range of activities such as:
- Creation of essential documentation including Risk Assessment, Validation Plan, Functional Risk Analysis, Test Scenarios, Test Reports, Operating Support Plan, Traceability Matrix, and Validation Reports.
- Collaborative efforts to identify regulatory and user perspective gaps within the system, facilitating necessary adjustments.
- Development of comprehensive test cases and active participation in system testing.
Notably, testing procedures were predominantly conducted by our team manually, with protocols being resolved by hand.
Upon completion of system testing, the infrastructure was initially deployed in a test environment, with eventual transition to a production environment. Following successful system tests, the client conducted additional infrastructure testing in the production environment before final system deployment.
With three dedicated team members – one Project Manager and two Validation Specialists – eConsulting collaborated closely with the client throughout the 4.5-month project duration. Regular status meetings were held weekly to review progress and discuss next steps, with additional meetings convened as needed for document review and discussion.
Result – Computerized System Validation (CSV)
Through collaborative efforts, the P4Lab system achieved successful validation, ensuring compliance with GMP standards. Additionally, the client experienced improved data visibility and enhanced management of material flow within the company.
The client expressed satisfaction with the team’s dedication, expertise, and professionalism throughout the project. The comprehensive support provided, including technical assistance and effective communication, earned positive feedback.
By leveraging eConsulting’s CSV expertise, the client successfully validated the P4Lab system, meeting regulatory requirements and improving operational efficiency.
If you need help with software validation (CSV), we’re here to assist you every step of the way. Contact us today to ensure your systems meet regulatory standards seamlessly.
