We offer a comprehensive computerized systems validation service, both in project implementation, management and coordination, and in maintaining the validation status.

We validate all types of computerized systems: 

We guarantee the correct operation and maintenance of your equipment, instruments and facilities. We help you resolve any deviations that are detected, maintain its proper functioning and comply with all regulatory requirements.

We qualify all types of equipment:
       ✓ Particle counters
       ✓ HVAC Systems
       ✓ Thermal equipment
       ✓ CIP/SIP cleaning systems
       ✓ Production equipment
       ✓ Analytical instruments

We offer the process to demonstrate that the IT infrastructure has been installed according to established specifications and that its operation is within the recommended limits when used according to its instructions.

There are two types of strategies:

       ✓ Horizontal Strategy: for medium and large IT infrastructures

       ✓ Vertical Strategy: for small IT infrastructures

Our team is expert in GxP audits and will allow you to support the quality and compliance of your regulated operations:

       ✓ In regulatory compliance (GMP, GDP, GLP, GCP, GVP)
       ✓ Supplier and internal audits
       ✓ From providers of technological services and Cloud operations
       ✓ Specific regulatory requirements (Data Integrity, Anexo 11, 21 CFR Part11,…)
       ✓ Clinical trials (GCP)

       ✓ Ensuring good practices

       ✓ Support in the development of Quality Systems

       ✓ GAPs assessments

       ✓ Support for Computer Systems Developers

Achieve homogenization and standardization in the application of data integrity principles (ALCOA+) through our specific methodology (DIRA). Ensure compliance with the main regulations (21 CFR Part 11, Annex 11 EU GMP).

       ✓ Definition of data flows