Qualification of IT Infrastructure
in GxP Environments, Data Centers, and GxP Clouds
Ensure Regulatory Compliance, Access Regulated Clients, and Guarantee System Security
We are experts in IT validation and qualification for Data Centers, Cloud Providers, and pharmaceutical and hospital environments, ensuring compliance with regulations such as:
- GAMP 5
- Annex 11
- 21 CFR Part 11
- ISO 27001
- ISO 13485
- ALCOA+
Common Challenges in Data Centers and GxP Cloud
-
Reliable infrastructure for the pharmaceutical industry
Being GxP Ready opens doors to high-level clients. - Attract leaders in healthcare and biotechnology
IT validation is key to gaining the trust of laboratories and hospitals. - Comply without risks in a regulated environment
Stay ahead of increasingly strict regulations and avoid penalties.
Common Challenges in GxP Environments
- Avoid sanctions and regulatory risks
Unqualified IT infrastructure may attract the attention of regulators. - Protect the integrity of critical data
Ensure information reliability in manufacturing, laboratories, and hospitals. - Pass audits without surprises
FDA, EMA, and ISO 13485 demand high standards. Be prepared and comply confidently.
Ensure your IT infrastructure's GxP compliance with our specialised qualification services for Data Centers, Cloud Providers, and GxP environments.
Meet international standards and gain access to regulated clients in the pharmaceutical and hospital sectors.
Our Solution:
IT Qualification Services for GxP Environments, Data Centers, and GxP Cloud
- Accurate compliance diagnostics
We evaluate the compliance status from the beginning, identifying gaps with a Gap Analysis & Assessment aligned to key standards. - IT Qualification and Validation
We verify hardware, software, and security (IQ, OQ, PQ), ensuring data integrity with audit logs and backup verification. - Audit Support
We prepare and guide you through regulatory inspections for smooth compliance.
What Systems Are Qualified in GxP Environments?
Our qualification covers a wide range of essential IT systems and components to meet GxP requirements, including:
- Software and Operating Systems: Validation of operating systems and key applications used in regulated environments.
- Networks and Communications: Evaluation of network infrastructure, including firewalls, segmentation, secure remote access, and cybersecurity standards.
- Databases: Validation of databases and information management systems to ensure data integrity.
- Backup and Recovery Systems: Validation of data backup and disaster recovery processes.
- Monitoring and Security Systems: Evaluation of network monitoring, access control, and security systems to meet regulatory requirements.
- ITSM Systems: Validation of IT Service Management platforms to ensure traceability and compliance in IT service management.
- Virtualisation: Evaluation and validation of virtual environments to ensure reliability, security, and regulatory compliance.
