• The Company
• Strategic business • CLiMET
  • Services • Job opportunities • Task performed
      
 
• Training Solutions
• Compliance Auditing Services
• Quality System Consulting Services
• Validation Services
• IT System Lifecycle Management
 

• Therma Validations
• Environmental Control
• Qualification of process equipment and analytical instruments
• Pharmaceutical Plants
• Manufacturing and Cleaning Processes
• Analytical Services
• Computer systems and automated controlling systems
• Informatic Tools for Clinical research
   
Computer systems and automated controlling systems
 
Through the validation of the computer systems we guarantee the efficiency and high quality of their maintenance.

A. We develop the following computer system validation and control activities:
- Preparation of the Global IT Validation Master Plan
- Preparation of the User Requirements Specifications (URS)
- Preparation of the Validation Master Plans (VMP)
- Evaluation of the compliance with 21 CFR part 11
- Analysis and auditing of suppliers
- Risk analysis (RA)
- Traceability matrix
- Configuration plan
- Migration plan
- Preparation and execution of protocols (DQ, IQ, OQ, PQ)
- Preparation and execution of the FAT and SAT tests
- Change control monitoring
- Incidents monitoring and closure
- Revalidations
- Recall plan