Audit Support Service

At SMART SPOC, we understand that regulatory audits can be complex and high-stakes—especially in the life sciences and regulated industries. Our Audit Support Services are designed to help you confidently navigate inspections and assessments by ensuring your systems, documentation, and processes meet all compliance expectations.

What We Offer:

• Pre-Audit Readiness Checks: We assess your validation documentation, SOPs, and systems to identify gaps and prepare you for audits.
• On-Site & Remote Audit Support: Our experts provide real-time assistance during audits from authorities like the FDA, MHRA, EMA, and WHO.
• Compliance with Global Standards: We help ensure alignment with 21 CFR Part 11, GxP, Annex 11, and other relevant regulatory frameworks.
• CAPA Planning & Remediation Support: Post-audit, we assist with Corrective and Preventive Action plans and documentation remediation.
• Training & Mock Audits: We conduct team training and internal audits to build confidence and reduce audit-related risks.

Why Choose SMART SPOC for Audit Support?

• Deep expertise in Computerized System Validations (CSV)
• Support across SAP/ERP, LIMS, QMS, spreadsheets, and lab systems
• Proven track record in passing audits and reducing compliance risk
• Custom solutions based on your business and regulatory needs