Case Studies

Safis Solutions audited processes, documentation, and overall quality system for a pharma company using a third party laboratory.

Big pharma calls Safis to audit all third party vendors involved with web-based application.

Safis audits all third party marketing and data capture for HIPAA and Sarbanes-Oxley compliance.

Quality audits of clinical investigator sites successful.

Audit & Remediation

Clear confidence in auditing and remediation

Safis Solutions has decades of collective experience in auditing. We take this knowledge and then apply it backwards-- inspecting a facility in the same way a regulatory body would. The result is our clients rest easy knowing that Safis Solutions' knowledgeable staff will execute auditing best practices to deliver a thorough and actionable audit report.

How we do it

Our ability to review third party vendors or partners minimizes risk and cost for our clients and provides clarity in the selection process. Safis Solutions' auditing services help drive sound business decisions. We also provide internal auditing services to help you monitor and assess your own internal quality assurance processes.

Internal quality and vendor assessment services for:

• Pharmaceutical & biologics
• Laboratories
• Device & diagnostics
• Data management service providers
• Blood and tissue banks
• Pre-clinical to Phase IV
• CROs
• International: US, Europe, Asia, Latin America
• CMOs

Complete Audit services include:

• Vendor GMP/GLP/GCP quality audits
• 21 CFR Part 11 audits
• Vendor qualification/assessment
• Regulatory and business process due diligence
• Mock audits
• HIPAA
• Pre-audit preparation
• ISO
• Internal GMP/GLP/GCP
• Sarbanes-Oxley

To learn more about the capabilities of Safis Solutions or to review industry specific case histories, please call 317-777-6200.