Coda Corp USA
Coda Corp USA is a trusted provider of Quality Systems services, partnering with top pharmaceutical, biopharmaceutical, and medical device companies. The company emphasizes continuous improvement, innovation, and collaboration to ensure safe, effective, and high-quality products. With a focus on regulatory compliance and industry best practices, Coda aims to help clients achieve operational excellence and product integrity.
Industries
Nr. of Employees
small (1-50)
Coda Corp USA
Fairport, New York, United States, North America
Services
End-to-end development, redesign, and implementation of quality management systems including document control, training, CAPA, audits, and management review outputs.
Project management services using Lean and Six Sigma techniques to identify variation, plan improvements, manage capital projects, and support technology transfer and PAI readiness.
Programs to strengthen QA functions, implement continual improvement, design audit and CAPA programs, and align quality outputs with management decision-making.
Design and execution of process validation, equipment/facility/utility qualification, validation planning, protocol generation, and validation reporting across manufacturing and packaging operations.
Configuration and validation of computerized systems (LIMS, MES, EDMS, EDC, PLC/SCADA), implementation of electronic records controls, automation change management, and related compliance training.
Support for regulatory strategy, response to findings, remediation planning, and engagement with rulemaking or public comment processes to align company positions with regulatory expectations.
End-to-end development, redesign, and implementation of quality management systems including document control, training, CAPA, audits, and management review outputs.
Project management services using Lean and Six Sigma techniques to identify variation, plan improvements, manage capital projects, and support technology transfer and PAI readiness.
Programs to strengthen QA functions, implement continual improvement, design audit and CAPA programs, and align quality outputs with management decision-making.
Design and execution of process validation, equipment/facility/utility qualification, validation planning, protocol generation, and validation reporting across manufacturing and packaging operations.
Configuration and validation of computerized systems (LIMS, MES, EDMS, EDC, PLC/SCADA), implementation of electronic records controls, automation change management, and related compliance training.
Support for regulatory strategy, response to findings, remediation planning, and engagement with rulemaking or public comment processes to align company positions with regulatory expectations.
Expertise Areas
- Quality system development and implementation
- Process validation and equipment qualification
- Automation and computerized system validation
- Lean and Six Sigma process improvement
Key Technologies
- LIMS (Laboratory information management systems)
- MES / MRP systems
- Electronic data capture (EDC)
- Electronic document management systems (EDMS)
News & Updates
The Biggest Story of 2012? Innovation!
Review of the pharmaceutical industry's achievements and challenges in 2012, including drug development, regulatory improvements, and industry growth.
New York State: A Leader in the Life Sciences
Highlights NYS's history, industry presence, research institutions, and government programs supporting biotech growth.
Cost Cutting and Quality
Discussion on the impact of economic pressures on pharmaceutical quality, supply chain, and regulatory compliance.
The Little 'c' in cGMP Isn't What It Used To Be!
Exploration of the evolving meaning of 'current' in cGMP and the importance of continual improvement in quality systems.
The Evolution of the Clinical Trial; Is Ethnopharmacology the New Frontier?
Future perspectives on clinical trials incorporating ethnopharmacology to account for genetic and cultural differences.
Food and Drug Regulations; Too Many, Too Few, or Just Enough?
Analysis of the balance between regulation and innovation in the context of drug shortages, safety, and market access.
The Biggest Story of 2012? Innovation!
Review of the pharmaceutical industry's achievements and challenges in 2012, including drug development, regulatory improvements, and industry growth.
New York State: A Leader in the Life Sciences
Highlights NYS's history, industry presence, research institutions, and government programs supporting biotech growth.
Cost Cutting and Quality
Discussion on the impact of economic pressures on pharmaceutical quality, supply chain, and regulatory compliance.
The Little 'c' in cGMP Isn't What It Used To Be!
Exploration of the evolving meaning of 'current' in cGMP and the importance of continual improvement in quality systems.
The Evolution of the Clinical Trial; Is Ethnopharmacology the New Frontier?
Future perspectives on clinical trials incorporating ethnopharmacology to account for genetic and cultural differences.
Food and Drug Regulations; Too Many, Too Few, or Just Enough?
Analysis of the balance between regulation and innovation in the context of drug shortages, safety, and market access.