Quality Engineering

We understand each Client’s Project needs can be unique in the requirements, scope, complexity. We therefore offer a flexible approach to each engagement with a dedicated cooperative team accountable and responsible for managing the client’s project. Our process oriented strategy is designed to accelerate the time to Project Deliverables and utilize Earned Value Measurement (EVM) techniques to ensure the engagement is trackable and achieves the defined goals on time and on budget.

• Automated System Implementation
• FDA Inspection Planning
• GMP Compliance Services
• Non-Compliance Remediation
• Project Management Services
• Quality System Audits
• Quality System Design
• Validation Audits
• Validation Master Planning
• Validation Program Assessment

• FDA Compliance Services
• Process Control System Validation
• Computer System Validation
• Equipment Qualification
• Instrument Qualification
• Software Validation
• Utility System Qualification
• Equipment Validation
• Facility Validation
• Process Validation

RS Quality Engineering supports each client by documenting deliverables as needed for efficient compliance with today’s quality engineering best practices. We utilize a streamlined Process Oriented Methodology (POM) with defined steps that are adaptable based on the client’s requirements.

• Deliverables
• Plans, requirement specifications
• Design control, system impact/risk assessments
• Component impact assessments
• Factory acceptance tests

• Installation qualification
• Operational qualification
• Performance qualification
• Process qualification/validation

We deliver services and deliverables by “focusing on the important” to each client’s unique needs, and by continually evaluating the progress toward those goals.

RS Quality Engineering begins each project by providing definition and context to the client’s requirements for success. Based on these requirements, planning and assessment of plausible risks are evaluated. After consensus, implementation of the plan occurs with continual monitoring to meet the client requirements. By focusing on continuous assessment response to each client, project deliverables remain the focal point of our team.