Equipment & plant validation

Validation is one of the traditional sectors in which we have acquired extensive breadth and depth of expertise both in production systems (water for pharmaceutical use and HVAC etc.) and equipment (for solid orals, creams, liquids and sterile products, etc.).

Computer System Validation

We are able to provide the following services in accordance with the current regulations and guidelines for the sector (GAMP, PIC/S Guidance, FDA 21 CFR Part 11, etc.):

• Quality system outline
• Policy outline
• Computer system validation
• VMP and VP of computerized systems
• User requirements outline
  and project documents reviews
• Suppliers audit
• Risk analysis-based approach
• Support to development and testing
• Gap analysis of existing systems and corrective action plans
• Validation and validation report
• Administrative SOPs definition
• Training on rules and guidelines