Design Group delivers Commissioning and Qualification (C&Q) solutions and services for client facility, utility, process, and packaging systems in alignment with the latest science and risk-based standards used in the industry including ASTM E2500 and ICH Q8, Q9, and Q10.

Trained professionals provide services including validation planning, specification development, risk assessments, project management, execution of technical studies, and equipment troubleshooting while assuring safe, efficient, and compliant C&Q services.

Design Group's multi-disciplined services allow for a partnership between the Regulatory Compliance, Control System Integration, and Enterprise Technology Consulting Practices to build a robust computer and software validation program for systems at all levels of the ISA 95 pyramid. Support can range from program development to development of clear and robust specifications, to the integration of key elements and ERES compliance, to the application of GAMP 5-based risk management tools, and the generation and execution of custom validation protocols.

Design Group provides process validation strategies demonstrating technical understanding of process development and manufacturing methods. These strategies effectively deliver process validation programs that incorporate scientific rationale and justification to align with regulatory guidance and industry standards.

We deliver cleaning validation services to incorporate a technological understanding of clean-in-place processes, chemical compatibility studies, cross contamination risk mitigation, sampling requirements and techniques, analytical method development and validation, and technical reporting to support cleaning validation activities.

Design Group delivers consulting services for the review of quality management systems, offering insight about the regulatory environment, recent trends, and techniques for continuous improvement concepts to ensure compliance with current regulations. Other services offered include regulatory compliance services for development of standard operating procedures, quality program documentation, annual product reviews, regulatory filings, root cause analysis, change management system documentation, and other regulatory and compliance management documentation.

We also offer regulatory compliance services for the development of standard operating procedures, annual product reviews, regulatory filings, and other regulatory management documentation.

Audit services support a wide range of regulations, standards, and industries including FDA Regulations (cGMP and GLP), ISO standards, ICH guidelines, European commission, and internal company standards for the biotech, pharmaceutical, and medical device industries using Quality Engineers and ASQ certified auditors.

Design Group professionals apply statistical and process management tools and process analytical technology (PAT) to design and implement complete solutions in process development. This is specifically in the areas of product development, manufacturing technical support, validation and technology transfer and use multivariate analytical (MVA) techniques and tools. These process development services support the formalization of critical process parameters and critical quality attributes as a key input to Process Validation.

To enhance our specification and validation services, we provide Kneat's paperless validation solution, trusted by many of the world’s largest life sciences companies.

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