RISK-ORIENTED APPROACH TO COMPUTERIZED SYSTEM VALIDATION

Our goal is to help solve your problems with the Computerized system (CS) validation on all levels of complexity - for categories 3, 4 and 5 according to GAMP; eliminate GMP inconsistencies for production, laboratory equipment, and for large systems of ERP, BMS, SCADA, LIMS, etc.

Our experience in the protection of works during inspections by regulatory authorities (WHO, PIC/S, State Medical Service) and cooperation with international experts allows us understand well what the inspectors will pay attention to during inspections:

  • Completeness of validation works and systematic approach to validation
  • Backup and recovery processes
  • Control of user access to equipment / systems
  • Change control in computer systems
  • Critical data risk analysis
  • Ensuring data integrity and appropriate data handling
  • Audit trail review and periodic review of the CS

We will audit your available documentation and bring it in line with GAMP 5 A Risk-Based Approach to Compliant GxP Computerized Systems and Annex 11 of the GMP Guidelines.

Costs

We minimize your costs for validation work as we already have validation documentation templates recommended by ISPE, expensive GAMP 5 manuals and trained staff.

LIST OF VALIDATION WORKS

Preparatory stage
  • Formation of the list of computerized systems of the enterprise, their categorization
  • Analysis of available system documentation
  • Analysis of the functionality of the system for compliance with CFR 21 Part 11
Documentation design
  • User requirements specification (URS)
  • Functional specification (FS)
  • Project specification (DS)
  • Software specification (SDS)
  • Hardware specification (HDS)
  • Creation of validation protocols and test forms
Validation
  • Validation tests
  • Documentation Registration
Final stage
  • Test results analysis
  • Creation of recommendations and CAPA
  • Development of a validation report