Sector
Biotechnology
Validation of biotechnological processes, laboratory equipment and LIMS systems under GxP. We ensure the robustness and reproducibility of critical production and quality control processes.
Applicable regulations
FDA 21 CFREMA GMPICH Q9ICH Q11GAMP 5
Do you work in this sector?
We have experts specialised in the regulations applicable to your industry. Tell us about your case.
Request informationServices for this sector
System Validation
Complete validation of computerized systems: ERP, LIMS, MES, mobile applications, medical devices and AI systems under GxP regulations and 21 CFR Part 11.
View service
Data Integrity
Assessment and improvement of data integrity controls in accordance with ALCOA+, with remediation plans and training to ensure reliable and auditable data.
View service
Training & Qualification
Specialized training programs in GxP, CSV, data integrity and regulatory requirements for quality, IT and operations teams.
View service