CSV and QA pharma

Our Milan, Rome and Bologna Pharma sector delivery centres are specialised in supporting the Quality Assurance and Computer System Validation.

Our teams rely on their in-depth knowledge of the pharmaceutical world, which covers industry regulations, operating processes, and production companies.  This knowledge includes production sites, active ingredients, production of sterile and non-sterile pharmaceuticals, and final stage packaging.

Activities are managed using GxP standard methodologies and processes.  Attention is paid to our partners’ needs and their Standard Operating Procedures. 

Our services include:

  • GxP and Data Integrity regulations process analysis.

  • Quality Management process analysis and ordinary and extraordinary administration support.

  • New or updated software requirement analysis and definition

  • The entire computer system validation process, including requirement management, drafting supporting documentation, and performing field tests.

  • Process risk analysis, modifications and new system, machine and process implementations

  • Checking the integrity of physical and electronic data and the analysis of corrective actions and supporting their implementation.

  • Project Management

  • Specialised training