21 CFR Part 11 electronic signatures, ISO 13485 compliance, CAPA management, and batch record control for pharmaceutical, biotech, and medical device companies. Built to survive any FDA audit.
Built for regulated environments
Compliant electronic signatures with meaning statements, dual-password authentication, and tamper-evident audit trails. Every signature timestamped, attributed, and immutable. Meets FDA 21 CFR Part 11 and EU Annex 11.
Controlled document workflows with mandatory review, approval, and effective-date scheduling. SOP, batch record, and validation document templates pre-built. Change control with impact assessment and CAPA linkage.
Investigation, root cause analysis, corrective and preventive action planning, effectiveness verification, and closure — all traceable to the originating deviation, complaint, or audit finding. Meets ICH Q10 requirements.
Audit your contract manufacturers, API suppliers, and critical vendors against ISO 13485 and GMP requirements. Maintain qualification status, re-audit schedules, and approved vendor lists in one place.
Maintain GMP training records, role-based curricula, and competency assessments for every employee. Auto-lock access to procedures until training is confirmed. Audit-ready training matrix in one click.
Product and process risk assessments aligned to ISO 14971. Hazard identification, probability and severity scoring, risk controls, and residual risk acceptance. Fully linked to CAPA and design history files.
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