Quality Management Systems (QMS)
GxP Gateway designs and validates robust quality systems for early-stage startups, late-stage and established commercial manufacturers.
Phase-Appropriate QMS Design
We build scalable quality systems that grow with your company, from lean startup models to full-scale commercial frameworks to include SOP development, quality manual drafting, and organizational hierarchy mapping.
Digital QMS & Part 11 Validation
We assist in the selection and validation of electronic quality management systems (eQMS) to ensure full 21 CFR Part 11 compliance. We can conduct software vendor audits, User Requirement Specifications (URS), and IQ/OQ/PQ validation protocols
Medical Device Quality Systems (Part 820)
We engineer and implement Quality Management Systems Regulations (QMSR) specifically designed to meet 21 CFR Part 820 requirements for medical devices. We support Design Control implementation, Device Master Record (DMR) development, and CAPA system alignment for
medical devices.
Risk Management & CAPA Framework
We integrate risk-based thinking into your quality culture to proactively identify and mitigate potential product failures. We can conduct ICH Q9 risk assessments, Root Cause Analysis training, and Corrective Action system design.