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.