MDSAP Program Management SOP — Audit-Ready Procedure for All 5 Jurisdictions

Process Package — MDSAP Program Management

The master MDSAP program SOP. Covers MDSAP Audit Approach P0002.010, the 5-chapter audit framework, MDSAP-Auditing Organization (AO) relationship management, audit cycle (initial + 2 surveillance + recertification), and the cross-jurisdiction map of vigilance and marketing authorization timelines.

What’s included:

• SOP-MDSAP-00 MDSAP Program Management — comprehensive procedure with: chapter-task matrix mapping all MDSAP audit tasks to internal SOPs, AO selection and management criteria, audit-readiness checklist (15 items), training matrix for the MDSAP audit team, KPI framework, and Annex A summary of all 5-jurisdiction vigilance timelines.

Why this package: MDSAP audits are stressful. This SOP is the playbook your team needs to know exactly what to expect, who does what, and how to coordinate the 5 jurisdictions in a single audit cycle. Particularly valuable for first-time MDSAP companies and for managing AO transitions.

Format: Microsoft Word
Updated: May 2026 — reflects MDSAP P0002.010 (Jan 2025 revision)
Delivery: Instant download after purchase