GCP Quality Management Systems for Monitoring Immune Response
ImmuneCarta is governed by an extensive Quality Management Systems (QMS) program that defines the high-level quality policies for immune monitoring. This program is applied throughout the organization in accordance with applicable GCP/GLP/GCLP regulations and guidelines, under which studies are planned, conducted, monitored, reported, and archived.
Quality Management Systems (QMS) policies for monitoring immune response encompass the organization and facilities, safety and personnel, computer systems and equipment, sample management and chain of custody, assay/method qualification and validation, study planning, sample processing and data analysis, reporting, document control, storage and retention of data.
Processes and Procedures for immune monitoring within ImmuneCarta's QMS are performed by highly qualified and trained personnel and recorded in controlled documents such as study work plans, Standard Operating Procedures (SOP), Client Specific Procedures (CSP), and study worksheets/forms. All documents are approved prior to use.
Customized Assays for measuring immune response to satisfy client needs are planned, developed and qualified and/or validated prior to implementation.
Result Reporting format and mechanism for immune monitoring is developed in unity with the sponsor to ensure the highest quality of interpretation, correlation, and effective communication of test results.
Quality Control (QC) reviews ensuring the performance of all laboratory testing for immune monitoring is controlled through the use of accepted quality control practices and documented procedures.
Quality Assurance (QA) Assessments performed by the Quality Assurance Unit are in accordance with GLP regulatory requirements, study plans and applicable procedures; in order to measure and monitor the performance of laboratory services, and to identify opportunities for improvement.
Proficiency Testing practices allow for the standardization of immune monitoring assays among laboratories. ImmuneCarta pioneered early inter-laboratory ICS and CFSE proficiency testing and continues to actively participate in several international Immune Monitoring Proficiency Testing Programs (ICS, CD34 Enumeration, MHC Multimer, and ELISpot); with consistent results well within the external gold standard references.