Services
GxP consulting in systems validation, data integrity, auditing and training for regulated industries in Spain and LATAM.
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.
- PV and URS
- AR, DQ, IQ, OQ and PQ
- Traceability matrix
- Validation reports
AI Validation
Validation of AI systems and models in regulated environments: ML algorithms, automated decision systems and AI software under GxP, 21 CFR Part 11 and EU AI Act.
- Explainability & traceability
- Risk management
- Acceptance criteria
- Model validation
SAP Validation
SAP validation in GxP environments under 21 CFR Part 11 and GAMP 5: QM, PP, MM, SD, HR and S/4HANA modules. Full coverage of upgrades, patches and regulatory updates.
- SAP QM, PM, MM, PP, SD, WM/EWM
- SAP HR/HCM and PS
- SAP S/4HANA and ERP
- Upgrade & patch management
Data Integrity
Assessment and improvement of data integrity controls in accordance with ALCOA+, with remediation plans and training to ensure reliable and auditable data.
- ALCOA+ assessment
- Gap analysis
- Remediation plan
- Team training
Auditing
Internal audits, technology vendor and third-party audits to identify compliance gaps and prepare your organization for regulatory inspections.
- Internal audit
- Vendor audit
- Data audit
- Findings report
Training & Qualification
Specialized training programs in GxP, CSV, data integrity and regulatory requirements for quality, IT and operations teams.
- In-person and online courses
- In-company training
- Certifications
- Educational materials
Process Automation
Digitalization of quality and compliance processes: paper elimination, electronic workflows and electronic signatures compliant with 21 CFR Part 11.
- Paper elimination
- Electronic workflows
- Electronic signatures
- System integration
Regulatory Consulting
Expert advice on the interpretation and application of GxP regulations: FDA, EMA, ICH, ISO 13485, MDR and other regulations applicable to your sector.
- Regulatory analysis
- Gap assessment
- Action plans
- Inspection support
Deviation & CAPA Management
Implementation of robust systems for managing deviations, non-conformances, OOS and corrective/preventive actions (CAPA) aligned with GxP regulations.
- Implementation of an IT quality system aligned with relevant GxP regulations
- Change control
- Deviation management and CAPA plan
- Data governance
- Periodic review
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