CSV Computer System Validation

Computerized systems used for GMP, GLP, and GCP-related processes can affect product quality, data integrity, or patient safety. Therefore, the GxP relevance of these systems should be assessed, and this activity should be considered within the framework of lifecycle management in accordance with EU GMP, Annex 11 (Computerized Systems) and US21 CFR Part 11 (electronic records).

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We consider the entire life cycle of the system, basing the validation of computerized systems on model V of GAMP 5 (A Risk-based Approach to Compliant GxP Computerized Systems), Planning, specification, configuration, verification, and reporting.

Our expertise in system validation ranges from non-configurable systems to highly customized systems

Validation of Control and Process Systems (SCADA, BMS/EMS, Process Control and Monitoring, etc.).
Validation of Laboratory Systems (LIMS, integration of chromatography systems, scales, and other laboratory equipment, both independent and networked).
Validation of Management Systems (ERP, Document Management, Quality Management, CAPA Systems, etc).
Comprehensive validation of Serialization Systems.
Validation of Cloud Systems: IaaS (Infrastructure), PaaS (Platform), SaaS (Software).
Validation of electronic data collection systems for Clinical Studies, according to the GCP.
Infrastructure Qualification.

We provide support including.

Advising, drafting, and implementing procedures and policies to ensure compliance with GxP (21 CFR Part 11, Annex 11 EU GMP).
Periodic review of the status of Validation of Computerized Systems.
Computerized Systems Retirement Plan.
Business continuity plan.
Disaster recovery plan.
Project Design Consulting: DIRA (Data Integrity Risk Analysis), Project Management, Conceptual Design, Requirements, Specifications, ATRA (Audit Trail Risk Analysis), etc…
Support and management of projects for the implementation of Computerized Systems, ensuring regulatory compliance from the design.

Data Integrity

We support our customers in defining and implementing everything they need to meet data integrity requirements:

Global advice on records and data management: Focused on data lifecycle.
Assistance with records and data management policies and procedures development.
Risk analysis of data management processes to find process weak points.
Training: To staff at all levels of the organization.
Inclusion of data integrity policies in the quality management system.
Implementation plans for data governance.
Design of systems that guarantee data quality and integrity.