Computer System Validation

The increasing complexity of systems, the innovation rush attributed to automation and robotization processes, electronic documents storage, and opportunities given by a careful and effective management of the Analytics have catapulted us into the digital era. On one hand, this new scenario amplifies the possibilities of efficiency and speed of execution; on the other hand, it poses the problem of the security and reliability of information technology at an increasingly high level of criticality.

Regulatory bodies all over the world have always perceived both the potential and the risks of a greater digitization of the world, and this is why in recent years the Life Sciences Normative have seen  increasing attention for the Computer Systems Validation.

AKKA’s consulting team is able to help clients manage the increasing level of information complexity, and support the ambitions of our customers. Our active participation in organizations such as ISPE and GAMP also puts us in a position of opinion and innovation leadership to help influence future innovations in the Life Sciences sector.

Our team of consultants can offer experience in the Selection and Validation of all main IT and Automation Systems, supporting strategic decisions and on-site project management with a deep knowledge of technology, processes and regulations.

• Validation Support:
  • ERP
  • EDMS, CAPA System, Deviation Tracking System, SOP Management
  • eCTD, Publishing Tools
  • LIMS, CDS, LDAS
  • MES, Production Control System
  • DCS, BMS, SCADA, HVAC
• Visual inspections & critical controls
• Risk assessment
• Gap Analysis Report & action plan
• Remediation activities
• IT systems inventory
• Business/GxP process analysis & mapping
• Strategic analysis/investment definition
• User requirements definition
• Supplier & software selection
• Supplier audit & assistance
• Infrastructure management
• Virtualization projects
• Integrated quality management systems