About
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.
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Keywords
quality management system development
computer systems validation
equipment qualification
process validation
software validation
quality system internal audits
quality system supplier audits
21 cfr part 11
Company Information
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Employees 1
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Founded 1988
Location
4700 Papermill Dr, Knoxville, Tennessee, United States, 37909