Quality Assurance
Overview
The Quality Assurance Unit (QAU) atSpringborn is responsible for ensuring that the facilities, equipment, personnel, methods, and records are in conformance with the Good Laboratory Practice (GLP) Regulations under which the study was performed. The QAU provides independent monitoring of quality-related issues and reports the findings directly to the Study Directors and Management.
The Quality Concept
The management at Springborn is highly supportive of the QAU and has adopted a philosophy that is based on the concept of total quality. Management, study directors, and scientific support staff work together using sound scientific procedures to produce studies that meet the needs of our customers. The QA staff ensures the quality and regulatory compliance of these studies. Springborn has demonstrated an organizational commitment to quality by providing the necessary resources to earn the confidence of our customers.
Function of the Quality Assurance Unit
The QA staff verifies the reliability of data, accuracy of the reports, and assures conformance with applicable Good Laboratory Practice (GLP) Regulations.
Study-Specific Inspections
QA staff reviews protocols and performs In-life inspections during each study to assure that laboratory procedures adhere to the study protocol, standard operating procedures, and GLPs and are accurately reflected in the raw data.
Facility Inspections
Facility Inspections are performed to evaluate laboratory practices. These periodic assessments provide a systematic review of facility records, laboratory SOPs, data forms and laboratory procedures to assure conformance with GLP Regulations.
The Quality Assurance Units
The QA staff at Springborn works under the direction of a Quality Assurance Manager and consist of full-time auditors. The majority of the auditors have a science degree as well as previous laboratory experience. This combination of experience and understanding of the GLP Regulations gives auditors a greater insight and understanding of the laboratory procedures and the ability to provide guidance to the Springborn staff. The staff has over 30 years of combined experience and belong to the National Society of Quality Assurance, North Carolina Chapter, Society Quality Assurance and/or New England Regional Chapter Society Quality Assurance.
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