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Auditing Services
Internal Audit Readiness
Internal Quality System Audit (Retainer) - Monthly or quarterly internal audit subscription available with CAPA tracking and coaching.
Regulatory Compliance Mini-Audit
2–3 hour focused review of a single area (e.g., CAPA, complaint handling, labeling).
Mock FDA / CLIA / ISO 9001 Audit
Full-scope simulation of regulatory inspection, with findings and CAPA plan.
Recall Services
Recall Readiness Assessment
Evaluate your procedures for recall preparedness. Identify gaps in traceability, notifications, and reporting workflows.
Active Recall Management
End-to-end support during an FDA-initiated or voluntary recall (Class I–III).
Deliverables Include:
- Recall strategy & FDA notification letter draft
- Press release and customer communication templates
- Mock FDA Q&A prep for firm representatives
- Tracking log & recall effectiveness check plan
Post-Recall CAPA & Remediation Audit
Evaluate root cause, verify effectiveness of corrective actions, and ensure closure documentation meets FDA expectations.
Deliverables Include:
- CAPA verification report
- updated QMS procedures
Recall Training & Workshops
On-site or virtual training for staff on FDA recall classifications, procedures, and crisis communications.
- Slide deck,
- Handouts,
- Attendance certificate
Confidentiality
BMC executes a Confidential Engagement Agreement and Non-Disclosure Agreements with standard statement of work (SOW)s. Pricing terms included.
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