GxP Compliance & Auditing

GxP compliance and auditing help life sciences organizations keep clinical, manufacturing, laboratory, and pharmacovigilance work aligned with FDA expectations and applicable GxP standards. Audits confirm that procedures match day-to-day practice, that records support decisions, and that quality oversight is working as intended. Viltis consultants support internal, vendor, and CRO audits with a practical focus on risk, CAPA follow-through, and inspection-ready documentation.

A useful compliance program is more than a binder of SOPs. It includes training people actually complete, change control that keeps pace with operations, deviation handling that closes with evidence, and management review that acts on trends. When those pieces drift, findings tend to cluster around incomplete records, overdue CAPAs, and weak supplier oversight. Our consultants help teams map where controls exist on paper versus where execution gaps create real regulatory exposure before an inspector asks the same questions.

Audit planning should follow risk. High-impact processes, recent system changes, and suppliers that touch product quality or trial data deserve earlier attention than low-risk administrative areas. We help clients build risk-based audit schedules, prepare agendas, and document observations in language quality and operations teams can act on. The goal is a clear path from observation to CAPA to verified effectiveness, not a long findings list for its own sake or a report that sits unread after the exit meeting.

For sponsor and manufacturing organizations in San Diego and beyond, Viltis provides audit support as consulting and staffing resources. We do not issue regulatory certificates or act as a certification body. Work products typically include audit plans, checklists, reports, and CAPA tracking inputs that fit the client's existing quality management system, SOP structure, and governance cadence so ownership stays with the quality unit.

Typical GxP compliance and auditing activities include

• Internal GxP audits across GMP, GCP, GLP, and related quality systems
• Vendor, CMO, and CRO qualification and routine audits
• Risk-based audit planning tied to process and supplier criticality
• SOP and training effectiveness reviews against observed practice
• CAPA identification, root-cause support, and effectiveness checks
• Pre-inspection gap assessments focused on recurring FDA themes

If audit findings keep recurring or your schedule has fallen behind growth, we can help reset priorities and close gaps with documentation your teams can defend in an FDA inspection. Contact Viltis to discuss where audit support would have the most impact on your program.