Quality Consulting Services include:
- Quality Management Systems
- Quality Assurance and Management Consulting
- Design and review of policies and procedures for regulatory compliance
- Design Controls and Design Control Training
- Design Control lifecycle processes
- Design specifications and reviews
- Risk Management and Risk Analysis
- Audits and Remediations
- Remediation activities for consent decrees, FDA 483 and warning letters
- Corrective and Preventative Actions
- Complaint Management
- Project Planning and Management services
- Systems and software compliance audits
- Full quality system compliance assessments
- Independent vendor qualification and selections
- Independent risk analysis and feasibility analysis
- Independent procedural reviews
- User and functional requirements elicitation and facilitation
- System Development Lifecycle Methodologies
- Computer Systems Validation Methodologies
- Business process analysis and re-engineering
- End to End Data Integrity plans and assessments
- Security and Infrastructure Assessments
- Strategic planning and evaluation for software solutions
- Customized systems and solutions to meet your needs
- In depth systems analysis, design and process engineering
- Functional requirements study, analysis, and documentation
- System and vendor evaluations; product capability assessments
- Disaster recovery and business continuity planning and assessments
- Assistance with FDA 483 and warning letter solutions