CSV and SQA
To ensure that your GxP systems, processes and records are in line with key regulations: FDA 21 CFR 11, EudraLex Annex 11 Computerised Systems, FDA General Principles of Software Validation and EMA Guideline on Computerised Systems and Electronic Data in Clinical Trials
Most of companies rely on SaaS (software-as-a-service) systems and trust service providers to have relevant compliance documentation and processes. It’s important to highlight that though the computerised system related tasks can be delegated to service provider, the ultimate legal responsibility for the data integrity, security and confidentiality lies with the sponsors and investigators.
Gaea offers a custom approach to computer system validation (CSV) and software quality assurance (SQA) based on recent GAMP 5 recommendations. We have expertise in assessing Category 3, 4 systems, completing small validation projects, assessing the systems from FDA 21 CFR 11 and EU Annex 11 compliance perspective.
Our CSV Specialist has in-depth knowledge of IT support aspects and can help to establish robust policies and procedures ensuring data integrity principle, which is the key in most guidelines (FDA, EMA, MHRA, WHO, PIC/S, ISPE, PDA).