Beaufort, LLC’s quality assurance and compliance services cover all aspects of quality system audits, performance analysis, development, implementation, and compliance with experience in the United States, Europe, Latin America, and the Asia-Pacific region. This includes FDA Quality System Regulations (QSRs), cGMP, ISO 13485 and many others.
Compliance
Beaufort’s capabilities ensure its clients a robust level of compliance through training and working with their staff or working independently in the following areas:
Services include:
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- Audit execution and readiness (FDA ISO 13485 audits, ISO 15971, FDA GMPs, etc.)
- Regulatory gap analysis (FDA ISO 13485, ISO 14971, etc.)
- Root cause analysis and corrective actions
Quality Systems
Using proven Operational Excellence principles, including Six Sigma and Lean Manufacturing, Beaufort works with our clients’ teams as coaches or active members to ensure that work streams, procedures, functional components, team roles, and responsibilities are properly designed and working effectively to meet FDA quality system regulations.
Services include:
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- Quality system audit services and quality system support
- Documentation control
- Complaint handling system development and implementation
Production & Process Controls
Beaufort plans, designs, implements, and executes product and process control methodologies including the following services:
Services include:
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- Validation and verification support
- Corrective action/preventive action (CAPA)
- Aseptic processing support
Design Control
Beaufort’s Quality Assurance team has the in-depth experience and operational capabilities to implement an effective design control program including:
Services include:
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- Establishing design control procedures
- Risk management
- Developing input/output validation and verification
Supplier Management
Beaufort, LLC, has extensive global experience in supplier base management throughout the product life cycle, from clinical trials to product launch at distribution centers.
Services include:
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- Procurement
- Supplier management support
- Supplier monitoring
