Quality assurance and quality control have always been the cornerstone of Quality Associates, Inc. (QAI). Our Quality Assurance & Scientific Support division provides consulting services in the area of Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) to companies on FDA and EPA regulations. GLP applies to non-clinical safety and environmental research during the development of new
products such as medicines, medical devices, industrial chemicals and pesticides. GLP gives assurance that study data submitted to government assessors is accurate and valid. On the other hand, GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting results of clinical trials that involve the participation of humans. QAI is continuing to expand its capabilities in these areas to better serve our customers.
Notably, our staff of quality assurance professionals come from specific scientific backgrounds, such as physiology, toxicology, microbiology, chemistry, field research, and many more. Therefore, they conduct quality assurance functions under GLP and GCP with an extensive understanding, allowing them to evaluate and create quality programs which meet the challenges of today’s regulatory environment facing our clients.
In addition, QAI also maintains a fully compliant GLP archive for storage of documents, research specimens and e-data. Since its acquisition by Konica Minolta, QAI has already started to expand its current archiving footprint to an even larger space and develop a new archival database system that will be web-capable and allow our clients immediate access to their information.