Computerized system validation

COMPUTERIZED SYSTEM VALIDATION

During the definition phase of the business case, we help the customer identify the requirements of potential solutions and support them in the selection and choice of suppliers

1. Concept

2. Project

We accompany our clients step by step in the project management of the system implementation, from the planning of the validation strategy to its release, ensuring compliance with GxP standards and satisfaction of business requirements, through a flexible risk-based approach.

3. Operation

During the operational phase of the system, we support the customer in the management of Change Management, Periodic Compliance Review, Business continuity & Disaster Recovery, and IT security processes to ensure that system compliance is maintained

4. Retirement

We ensure the correct decommissioning of systems with a focus on proper data management: archiving, migration and/or data destruction.ne.

Our validation expertise is backed by in-depth knowledge of GxP processes and related systems such as:

IT Business Systems (e.g., ERP, LIMS, MES),
Pharmacovigilance Systems (e.g. ARGUS,
AERS, SafetyDrugs, Veeva Safety)
Laboratory Systems (CDMS, HPLC, GC,
HPLC, GC, UV VIS, Difrattometro, Bilance,
Microbiological equipment)

Manufacturing Systems (e.g PLC, SCADA, Equipment, eBRS, Dispensing Systems)
Clinical Applications (e.g. Oracle Clinical, DataTrak One, Veeva Vault CDMS, Veeva eTMF, Custom eCRF)

Our CSV services cover all phases of a system's life cycle:

Definition of Policies and SOPs on validation processes for IT systems
Vendors Selection and Qualification
Computer System Validation Strategy
GxP Risk Assessment
Process Mapping & definizione User Requirements
Review of suppliers' technical documentation
Design Review
Test strategy definition and execution
Validation Reporting
Data Migration Strategy and Execution
Change Management
Periodic Compliance Review
Business Continuity & Disaster Recovery
Computer Inspection Readiness Support
Infrastructure Qualification
Decommission Planning and Reporting
Data Archiving