No deviation Information

Founded in 2007, No deviation is a trusted partner to pharmaceutical and biotech companies seeking smarter ways to deliver compliance. From engineering consultancy to CQV execution, regulatory compliance, and digital enablement, we support our clients across the entire project lifecycle in Asia, Europe. We specialise in: CQV (Commissioning, Qualification & Validation) Lean, risk-based approaches aligned with GAMP 5, Annex 15, and ASTM E2500. Quality, Compliance & Regulatory Audit readiness, QMS remediation, documentation, and training. Project Management & Technical Support From operational readiness to vendor coordination. Digital Enablement Implementation of paperless validation (e.g. Kneat Gx), data integrity, and process digitalisation. Specialised Training & Talent Support Upskilling programs Our approach is rooted in patient safety, process understanding, regulatory compliance, and a constant drive for operational excellence in terms of safety, quality, delivery, and cost. If you’re troubleshooting a deviation, planning a major CQV deployment, or scaling digital validation tools, we work side-by-side with your teams to deliver meaningful outcomes. Our methodology draws from ICHQ9 risk principles, with a hands-on framework: Understand - Observe - Define - Implement. Want to learn more about paperless CQV, digital QMS, or project-ready resources? We’re happy to talk. Visit nodeviation.com to explore how we can support you.