Infrastructure
The DrugCard platform is hosted on Amazon Web Services (AWS) using an Infrastructure as a Service (IaaS) model. AWS data centers are ISO/IEC 27001 certified, ensuring a high level of information security, availability, and resilience.
To ensure data protection and system availability:
- Daily automated backups of system data are performed;
- Periodic backup restoration testing is conducted to verify data recoverability;
- Disaster recovery testing is performed on a regular basis to confirm system resilience and readiness in the event of major incidents.
Regulatory Compliance
DrugCard is designed, developed, and operated in alignment with internationally recognized best practices for pharmacovigilance and GxP-relevant computerized systems. The platform follows a quality-driven and risk-based approach to ensure data integrity, patient safety, and regulatory compliance throughout the system lifecycle.
In support of this approach, DrugCard is developed in accordance with applicable pharmacovigilance and
computerized system regulatory requirements, including but not limited to:
- EMA/95595/2022 – Guideline on Good Pharmacovigilance Practices (GVP)
- EU GMP Annex 11 – Computerised Systems
- GAMP 5 – A Risk-Based Approach to Compliant GxP Computerized Systems
Quality Management System
DrugCard operates under a Quality Management System (QMS) that is certified in accordance with ISO 9001.
The company has established a Quality Policy aimed at:
- Continuous improvement of services and processes;
- Meeting regulatory and customer requirements;
- Ensuring consistency, reliability, and transparency;
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Delivering high-quality solutions that create value for our customers
and that we can be proud of.
Artificial Intelligence and Advanced Technologies
DrugCard incorporates advanced artificial intelligence and modern data processing technologies in line with international best practices for regulated environments, with the objective of improving efficiency, consistency, and scalability of pharmacovigilance literature monitoring while maintaining scientific rigor and regulatory control.
AI-driven functionalities are applied to support and enhance literature monitoring and regulatory intelligence processes, including but not limited to:
- AI-based categorization and prioritization of literature articles;
- Support for efficient screening and identification of safety-relevant information;
- Reduction of manual effort while maintaining human oversight.
Data Security and Access Control
Role-based access control and unique user authentication
Password policies and access monitoring
Audit trails for user and system activities
Secure handling of data in line with applicable data protection requirements
Audit Readiness and Transparency
DrugCard has successfully undergone multiple client and third-party audits with no critical findings, demonstrating a high level of compliance, transparency, and operational maturity. The company actively supports customer audits by providing relevant documentation, validation evidence, and compliance information.
platform features.
