Medical Information Compliance Checklist
Medical Information teams sit at the intersection of scientific exchange, patient safety, regulatory compliance, and reputational risk. As regulatory expectations continue to evolve, organisations must ensure their Medical Information function is not only responsive and scientifically accurate, but also demonstrably compliant, documented, and inspection ready.
This checklist is a practical resource to help organisations assess the effectiveness and compliance of their Medical Information operations across the full enquiry lifecycle. It covers key areas including:
- Governance and oversight
- SOPs and operational controls
- Enquiry handling and documentation
- Scientific response management
- Adverse event and product complaint escalation
- Off-label enquiry management
- Training and competency
- Vendor and partner oversight
- Data integrity and computerised systems
- Quality monitoring and CAPAs
- Digital and omnichannel activities
- Inspection readiness
Designed for pharmaceutical, biotech, and healthcare organisations of all sizes, this checklist can support internal compliance reviews, audit preparation, vendor oversight activities, and continuous improvement initiatives.
Common compliance risks within Medical Information often arise from inconsistent documentation, unclear escalation processes, inadequate oversight of outsourced activities, delayed safety reporting, and insufficient evidence of control. This checklist is intended to help teams identify potential gaps early and strengthen operational readiness before they become inspection findings.
Assess your Medical Information inspection readiness and identify compliance gaps before inspectors do.
Download the Medical Information Compliance Checklist:
Ready to go beyond the checklist?
A checklist identifies where gaps may exist. Our pharmacovigilance experts help you close them — with the depth, context, and inspection-readiness assurance that comes from decades of hands-on experience.
- Medical Information compliance gap assessments and programme reviews
- SOP development, review, and alignment to current regulatory expectations
- Inspection preparation, mock inspections, and CAPA support
- Outsourced MI operations and vendor oversight services
- Training design and delivery for MI and safety teams