Beaufort, LLC defines an effective quality assurance (QA) system as a combination of outstanding business performance and full regulatory compliance. Thus, we have built a skilled, cross-functional, multi-cultural team with a proven record in the biopharmaceutical, diagnostic and medical device industries. Our team can provide that all-important balance between quality and compliance using current industry standards and the latest management methodologies.
Our experienced analysts work directly with your quality assurance organization to assess and manage critical processes across the entire supply chain network. These include:
Quality System Audits and Gap Analyses
Beaufort’s expert auditors can prepare your team to manage and effectively perform a compliance audit domestically and internationally for:
- FDA Quality System Inspection Techniques (QSIT)
- All CFR requirements
- Internal cGMP audits
- External supply chain audits of vendors, contract manufacturing, and sterilization services, among others
Risk Management
We can develop ICH Q9-appropriate compliance shields and defendable positions by conducting a thorough comprehensive risk analysis for numerous case scenarios, then implementing remediation plans based on that analysis. We can also help implement risk identification, assessment, mitigation, elimination, and communications programs.
Quality System design and implementation
Our extensive experience in quality system design enables us to identify and implement the right system for your needs. We incorporate project management, employee training, audit program design, corrective and preventive action system design, calibration system design, documentation control, and pre-registration readiness assessment audits into the development process.
Governance structures
Today’s regulatory governance structures can be complex to develop and manage. Yet inadequate controls expose you to product liability actions, product recalls, and Quality System (QS) regulation violations. We bring together change control, material review boards, and crisis management principles to develop and implement control systems that work within your corporate culture.
Global supplier management and compliance
Our multilingual and multicultural consultants have extensive experience in Europe, Asia and South America. Our goal is to provide comprehensive supplier management from the initial selection and qualification of vendors to post-approval market surveillance in any country in which you operate so your suppliers maintain regulatory compliant quality systems.
Complaint handling system design and implementation
We can design and implement a complaint handling system that ensures global regulatory compliance. Our team can also bring quality systems to support investigations, corrective and preventive actions, customer satisfaction, and regulatory reporting requirements.
Corrective and preventive action system design and implementation
Poor corrective and preventive action (CAPA) and investigations are among the most common FDA 483 deficiencies. Our industry experts will design and implement a complete closed-loop CAPA system that ensures regulatory compliance.
Six Sigma Methodology
Our management experts can bring Six Sigma principles and Lean Manufacturing Practices from the plant floor to your entire organization to eliminate waste, improve quality and improve customer satisfaction.
Standard operating procedures (SOP), work instruction design, harmonization, and implementation
We work alongside your employees to develop SOPs and ensure they are coordinated with and effectively implemented between multiple facilities within your organization.
Software and system validation
Our software and system validation experts can help develop and execute master validation plans and protocols to meet global regulatory requirements.
Quality systems training
Our training specialists can establish training notification and tracking systems and develop and deliver training materials from general good manufacturing practice (GMP) content to customized instructional topics.
Inspection readiness training and Mark inspections
We can conduct mock regulatory and GMP compliance audits and provide employee training to ensure your organization is in a constant state of audit readiness.
Documentation system development
We can create a manageable documentation system appropriate to your company’s research and operational environment.
