Qualification
Comprehensive Services
ASYS Life Science offers comprehensive services for successful qualification. From the creation of qualification-related documents to professional support during FAT and SAT, we are at your side with our many years of experience. Our goal: to support you on the path to validation, meet regulatory requirements, and ensure your quality objectives are achieved in the long term. We consistently apply a risk-based approach to ensure efficient and successful qualification of the automation solution.
Solutions and Training from a Single Sourcefor quick processing
Risk-based Approachfor efficient and successful qualification
Audit SecurityAll relevant qualification documents for successful audits
Services for
Successful Qualification
- Qualification plan with corresponding qualification phases (DQ, IQ, OQ)
- Risk analysis and workshops in accordance with GxP
- Traceability matrix
- Specification documents (FDS, HDS, SDS)
- Implementation of IQ and OQ
- FAT and SAT support
- Change management
Qualification in Accordance with International Standards
Our qualification services are based on the GMP guidelines of the EU Commission, the GAMP5 guidelines, and the FDA 21 regulations.
- GxP
- GAMP5
- FDA 21 CFR Part 11
- MDR
- Change Control
