Stibo Systems GxP Compliance Overview
Stibo Systems’ software and solutions are used by organizations in regulated industries such as pharmaceuticals, healthcare, and life sciences - sectors governed by GxP requirements. Our Master Data Management (MDM) platform is designed to support customers operating in GxP-compliant environments. Stibo Systems’ cloud operations are governed by standard operating procedures (SOPs) that are validated through structured checklists and aligned with GxP principles. These procedures are embedded in our quality management framework and support lifecycle validation, audit readiness, and traceability across our MDM Platform.
Our platform delivers critical capabilities such as data validation, audit trail management, and continuous data quality monitoring - key pillars of GxP. These controls enable customers to align their use of Stibo Systems technology with applicable GxP guidelines.
To support this, we’ve prepared a GxP Compliance Letter that outlines how our internal controls and product features align with GxP principles. The letter offers assurance that measures related to security, confidentiality, and availability are in place, and it specifically addresses how our products can be configured and used in accordance with GxP regulations in MDM SaaS environments.