We have more than 20 years of experience and professionals specialized in solutions to optimize your GxP processes through the validation of computer systems and regulatory consulting. We specialize in the digital transformation GxP processes, ensuring regulatory compliance, improving the efficiency of the pharmaceutical and biotechnology sector.
Pharma & Biotech
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:✓ Laboratory instruments
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)
We support you through consulting services such as:
✓ 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).
We accompany you in the development of policies and procedures to maintain data integrity. In addition to:
✓ Definition of data flows
Within the Pharma & Biotech area, there are 4 new aspects that aim to respond to different market needs that exist today. What are we talking about?