The QSR/cGMP compliance consulting will be conducted in accordance with FDA抯 requirements of medical device manufacturers (21 CFR Part 820 - Quality System Regulation and its interpretations). We will support our clients in building an overall QSR/cGMP - compliant quality system in terms of hardware, software, and personnel. Our experienced consultants will conduct on-site consultation in conjunction with off-site document review.
Service
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QSR/cGMP Compliance Audit and Gap Analysis
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General QSR/GMP audit
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Special QSR/GMP audit (in particular aspect)
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Audit on contractors
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QSR/cGMP Compliance Review of Facility Design and Construction
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Guide QSR/GMP requirements for facilities
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Review design drawings
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Audit on constructions
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Management Control System
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Quality policy
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Management representative
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Quality control procedures
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GMP and SOP-based job function training
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Management review
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Internal audit
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Design Control System
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Design control procedures
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Design project plan
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Design inputs and outputs
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Test, verification, and validation
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Design changes
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Design transfer
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Design history files
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Documentation Control System
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Corporate level documents
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Management level documents
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Operational level documents
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Material Control System
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Vendor evaluation and control
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Material incoming, storage, and dispatching
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Facility and Equipment Control System
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Facility and equipment qualification
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Calibration and maintenance
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Production and Process Control System
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Process validation
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Process monitoring
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Batch records and SOPs
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Corrective and Preventive Action (CAPA) System
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Collect and analyze quality data
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Investigate non-conforming products and quality issues
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Implement and follow-up corrective and preventive actions
Other Service
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Mock FDA Pre-approval Inspections (PAI)
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Mock FDA Routine Inspections
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Response to FDA 483s
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Response to FDA Warning Letters
Training
Affiliates
Link to "Services" for more information.
