Assess
Clause mapped gap report with risks, owners and a timeline you can execute.
MDSAP
MDSAP audit readiness for confident inspections
Prepare with a clause mapped plan, run inspector style mock audits and walk in with evidence that answers real questions.
Zero surprises
Mock audits that mirror real inspector flow
Mock audits that mirror real inspector flow
Evidence map
Records linked to clauses and questions
Records linked to clauses and questions
CAPA closeout
Clear actions with dates and owners
Clear actions with dates and owners
Calm inspection
Roles, script and documents ready
Roles, script and documents ready
Scope
What we execute and what you receive
We prepare your team for MDSAP inspections with a plan that reflects real auditor behavior and local requirements.
Audit preparation tasks
- Clause mapping and targeted gap assessment
- Evidence inventory and document clean up
- Mock audit with inspector style questions
- Roles and room logistics for the inspection
- Backroom and runner process definition
- Training for front room and subject matter experts
- Supplier evidence review and sampling
- Internal audit refresh where needed
- CAPA planning and risk based prioritization
Deliverables you bring to inspection
- Gap report with clause map and priority actions
- Evidence index with links to records
- Mock audit report and remediation plan
- Front room script and roles chart
- Backroom tracker template and sampling plan
- Training records and competency matrix
- Updated procedures and forms where required
- CAPA log with owners and due dates
How it works
From gap to inspection day step by step
We align the plan with your device, sites and markets so each activity builds inspection ready evidence.
Implement
Evidence clean up, training, supplier sampling and internal audit refresh.
Inspection day
Front room, backroom and runners follow a script with clear handoffs and trackers.
FAQ
Common questions
How far ahead should we start preparing?
Most teams benefit from starting 10 to 15 weeks ahead of inspection to complete remediation and training with margin.
Do you simulate our specific audit sequence?
Yes. Mock audits follow the process sequence and sampling approach used by inspectors for your product and sites.
Can you support multi site inspections?
Yes. We coordinate roles, evidence and communications across multiple locations with shared trackers.
Do you help during the inspection?
Yes. We can stay on call or on site to manage backroom flow, answer questions and support responses.
Ready for a calm MDSAP inspection?
Book a quick call to map actions, owners and dates. Walk in confident and prepared.