What we mean by Part 11 / Annex 11 support
Novaqis Technologies LLP designs the suite so electronic records, electronic signatures, audit trails, authority checks, and deployment options can be validated against US FDA 21 CFR Part 11 and EU GMP Annex 11 themes. Fit depends on how you configure workflows, identity, and SOPs.
GAMP 5 positioning
Novaqis is offered as GAMP 5 Category 4 configured commercial software: you configure forms, workflows, roles, and sites; you do not need to modify product source to go live. Category 5 custom code, if any, sits outside the core product and is called out in your validation plan.
What you still validate
- User requirements and risk assessment for your processes and sites
- Installation, operational, and performance qualification in your environment
- SOP wording for signature meaning, training gates, and print policy
- Interfaces to instruments, ERP, or other systems you connect
What we do not claim
We do not claim that installing Novaqis makes a site FDA-, MHRA-, WHO-, or CDSCO-approved. Inspectors assess your quality system. Our GAMP 5 glossary entry and validation walkthrough explain how packs map to typical URS items.