Standards mapping: align processes and artifacts to frameworks like ISO 9001, ISO/IEC 27001, IEC 61508/62304, DO‑178C/254, 21 CFR parts, SOC 2, and customer mandates.
Risk management: hazard analysis, FMEA/FMECA, risk registers, and mitigation verification.
QMS & SOPs: authoring/refreshing procedures, templates, forms, and records with clear ownership and training plans.
Verification & validation packages: V&V plans, protocols/scripts, evidence capture, and summary reports ready for audit.
Audit readiness: gap assessments, mock audits, CAPA planning, and remediation execution.
Metrics & reporting: KPIs for quality, flow, and reliability (e.g., defect leakage, cycle time, DORA), automated dashboards.