CSV AND IT AUDITS
CSV and IT System Providers audits
IT systems in the pharmaceutical sector must guarantee security, reliability and compliance with GMP regulations. Therefore, we support companies with compliance audits of software and IT service providers (IaaS, PaaS, SaaS), verifying the robustness of processes and compliance with applicable guidelines.
What do we assess?
✔ Compliance with data integrity requirements, 21 CFR Part 11 and EU GMP Annex 11
✔ Quality and reliability of IT suppliers
✔ Adherence to applicable guidelines (ISPE GAMP 5, ICH, PIC/s)
✔ Efficiency in systems life cycle management
What sets us apart
Regulatory focus
We help you reduce risks and be ready for regulatory inspections.
Specialist approach
Our auditors are professionals with direct experience and technical and regulatory knowledge.
Beyond checklists
We identify critical points and opportunities to make your processes more robust and efficient.
Customer focus
We adapt each audit to your needs, with flexibility and maximum attention to the business context.
Our services
CSV and Data Integrity
CONSULTING
Qualification
CONSULTING
Calibration
CONSULTING
Engineering
CONSULTING
Digital Innovation
CONSULTING
Project Management
CONSULTING
GMP Consulting
CONSULTING
In-house training
TRAINING
CSV and IT Audit
AUDITING
GMP Audit
AUDITING