The Solution
USDM developed and executed a plan to prepare for MDSAP
- Quality management policies and procedures were assessed, updated, and harmonized on-time and on-budget
- Implemented naming and numbering conventions for documents and records
- 35 policies and procedures created or updated to align with MDSAP, 21 CFR Part 830, and ISO 13485:2016
- 55 work instructions and 144 forms and templates created or updated
- Delivered first comprehensive GMP training for the organization
from initiation to approvals
policies, procedures, work instructions, and forms updated