STERICHECK Computer System Validation
Computer System Validation
The safety of being able to entrust
We manage the validation of IT systems supporting production and Quality Assurance, with an impact on product quality.
We offer consulting and preparation to the inspection.
We develop quality systems.
- IT System Lifecycle Management
- Implementation of IT&QA policies
- IT Global Validation Master Plan
- URS development
- Traceability matrices
- CFR21 Part 11 including:
- control of compliance degree
- compliance
- LIMS
- ACC21CFR (compliance with CFR 21 part 11 for Access)
- GxP Audit & remedation plan
- Gxp Risk Assessment
- CFR21 part 11 managment
- QC Compliance laboratory
- GMP Assessement detection for laboratory
- drafting and implementation of management & security SOP
- validation of control and analytical equipment (stand-alone and network)systems
(HPLC, GC, IR and UV Spectrometry, Gas mass)