Laboratory Reliability and Compliance Services
Our approach to laboratory compliance is built upon a strong technical understanding of the instruments and systems being validated. The science and engineering professionals at CSA Soliance are well versed in many analytical techniques. Coupled with our knowledge of FDA GMP requirements and standard industry practices, we offer the most valuable and cost effective laboratory compliance solutions in the service industry. We offer qualification (IQ/OQ/PQ) services for instruments and equipment, and software validation services for workstations and enterprise systems.
CSA Soliance works closely with your team to develop requirements and protocols that ensure equipment and instrumentation is designed and configured to meet your laboratory’s needs. We are proficient at writing and executing IQ/OQ qualifications that confirm and challenge established tolerances. Our staff also has applied experience that is well suited for developing and conducting specific PQ qualifications that demonstrate functional consistency to meet laboratory demands. Whenever possible, CSA Soliance employs a risk-based approach to validation that reduces costs and time to completion.
Validation is necessary to clear FDA compliance hurdles, but a strong validation program can do much more. Efficiency improvements and reduced costs can be achieved by optimizing your laboratory assets and processes. To stay ahead of FDA and international regulatory expectations, relay on CSA Soliance to help you implement proven strategies for your laboratory compliance programs.