Focus Compliance & Validation Services provides consulting, training, and auditing services to assist our clients in achieving and maintaining FDA regulatory compliance. Our core areas of expertise include: computer system validation; quality system development, implementation, maintenance, internal audits and supplier audits; response to agency actions including 483s and warning letters; FDA mock inspections and mock recalls; quality system training; risk management; process validation and equipment qualification; and related assistance. We have experience providing these services in the medical device, pharmaceutical, and biotech industries.