Reduce errors, validate processes and systems, and scale pilot setups and manufacturing with confidence. SigmaNexis brings advanced Six Sigma and compliant engineering to help you move from uncertainty to clarity.
Validation (CSV, PQ/OQ/IQ), product & process design, test methods, vision systems, data workflows, and strict GMP/ISO expectations.
Confusion, doubt, and constant pressure to scale while staying compliant without enough clarity on what “good” looks like.
Patients deserve safe, reliable, affordable products. Teams shouldn’t struggle with unclear requirements or inefficient processes.
We’ve worked across complex life‑science environments. We know how stressful it is when variation increases, quality drifts, or validation requirements get unclear—especially under GMP and ISO.
“Clear methods, correct documentation, and the right statistical tools turn uncertainty into control.”
SPC, MSA, DoE, DMAIC, CPV etc. tailored to regulated manufacturing.
Develop, validate, and transfer robust test methods with the right sample sizes.
Design and validate camera‑based inspection with traceable performance.
From concept to production—engineer solutions built for scale and compliance.
Process or Computer system validation aligned with GxP and ISO expectations.
Statistical workflows and data integrity that stand up to audits.
Get a 30-min assessment where we look at your validation requirements or six sigma project.
Delivered for major med‑tech and pharma organisations. NDA‑safe references on request.
“SigmaNexis helped us validate our vision systems and reduce false rejects by 9%..”
Share your design or process capability gaps, test method issues, or validation concerns. We’ll help you apply Six Sigma tools to stabilize quality for scale - secure and fast.