Ajete GxP Consultancy delivers specialized automation engineering and asset‑management expertise for the life‑science industry. Ajete GxP help manufacturers commission, qualify, and manage automated production systems to ensure reliably, efficient, and full GxP compliance.
Works to GAMP 5 21 CFR Part 11 EU GMP Annex 11
Sterile and non-sterile production
Intelligent approaches, delivered to meet industry standard, and solutions clients can sustain after handover. Each service stands on its own or combines across a project.
PLC · HMI · SCADAControl system design and delivery for regulated production: from URS through code, testing and handover.
CQVRisk‑based verification that confirms your control systems meet every requirement backed by clear, defensible documentation.
Maintain qualified equipment reliable, calibrated, and compliant throughout its entire lifecycle.
Owner-side leadership of automation and facility projects, from business case to first production batch.
Ajete GxP Consultancy is a specialist consultancy with more than 20 years in regulated production. The consultant who scopes the work is the consultant who delivers it.
To provide expert consulting that lets life-science companies focus on their core business while meeting regulatory compliance requirements efficiently and effectively.
To be a trusted consulting partner of choice in the life-science industry, recognized for reliable, client-focused solutions that help organizations navigate complex regulatory landscapes and achieve operational excellence.
GMPGLPFDA 21 CFR Part 11GAMP 5