QUALIFICATION OF COMPUTERIZED SYSTEMS
We guarantee the reliability of data and the correct operation of IT solutions that affect the quality of pharmaceutical products.
Verification of system correctness- Assessment of suitability for purpose
- Confirmation of process stability and reliability
- Preparation of documentation for audits and regulators
COMPREHENSIVE VALIDATION OF IT SYSTEMS IN PHARMACEUTICALS
We perform a full cycle of qualification and validation of computerized systems used in the pharmaceutical, medical, and scientific fields.
Our goal is to ensure the reliable operation of software and hardware solutions that affect product quality, control, and management processes in accordance with GxP requirements.
Our team of specialists conducts detailed system analysis, functional testing, data processing accuracy checks, procedure documentation, access and logging verification, and risk assessment.
The result is documentary confirmation of the correctness, safety, and compliance of the system with regulatory requirements, which is critically important for audits and certifications.
What's included
Requirements analysis and system risk assessment
Functionality and logic testing
Testing the correctness of data process. and storage
Access validation, logging, and security
Preparation of a complete package of GxP document.
What you get
Guarantee of stable and correct operation of IT systems
Reliability and integrity of electronic data and reduction of risks during inspections and audits
Compliance with GAMP, GDP, and other standards
Need advice?
Get answers to all your questions by phone.
Our specialist will advise you free of charge.
