Computer Systems Validation & Regulatory Compliance
We ensure full compliance with comprehensive solutions in validation, data integrity, information security governance, and quality management.
Validation of Computerized Systems
Complete validation solutions for critical production, quality control, laboratory, and management systems. We comply with GAMP 5, ANVISA, FDA, EMA, GMP, and international best practices.
IT Infrastructure Qualification
Equipment Qualification
Laboratory and Production Equipment
Qualification of critical equipment for clinical, quality control, and production laboratories, strictly adhering to GMP standards.
- On-demand documentation and protocols
Execution & Integration
Execution of qualification protocols based on risk analysis. Integration with validated LIMS and ERP systems, optimizing audit readiness.
A decision capable of changing the game
Large companies in the market have already recognized our global potential and have become our allies. Your company could be next.
Data Integrity
Protect your critical data with ALCOA+ controls, fully compliant with FDA 21 CFR Part 11 and EMA Annex 11.
Risk Governance and Information Security
Audits
Internal and Supplier Audits
- Complete regulatory diagnostics of your environment
- Audits for supplier and third-party qualification
Simulations and Preparation
- Simulation of ANVISA, FDA, and EMA audits
- Gap analysis, corrective action plans, and team training for real inspections
We ensure your company is ready for inspections, preventing non-compliance and potential regulatory issues!
Trainings
We empower your team to ensure performance, compliance, and regulatory risk reduction.
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