Cloud Computing
Novo Compliance’s commitment and support for our client alignment and regulatory compliance in Cloud computing utilizing bespoke frameworks through multiple systems transforming potential risks and heightened regulatory scrutiny into comprehensive, forward-looking and transformative systems compling with global regulations and standards including FDA 21 CFR Part 11, EU GMP Annex 11, HIPAA, and ISO 27001. These regulations mandate secure data handling, validated infrastructure, traceable audit trails, and documented evidence that systems perform consistently within defined specifications. Our teams resources whether virtual or embedded supports our clients requirements for compliance beyond technical controls developing required governance over data residency, vendor accountability, change management, and critical requirements for data integrity and security, when handling electronic records and electronic signatures (ERES), Protected Health Information (PHI) and Personally Identifiable Information (PII). In cloud environments, life science companies face multiple challenge maintaining control over regulated data while relying on third-party providers. This requires rigorous qualification of cloud vendors, implementation of role-based access controls, encryption protocols, and continuous monitoring to ensure data integrity and system reliability. Regulatory bodies increasingly expect provable compliance through automated reporting, real-time observability, and risk-based validation strategies.
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