Quality Assurance (QA) is the systematic monitoring and evaluation of the various aspects of a project, service or facility to maximize the probability that minimum standards of quality are being attained by the given process.
CTSI Quality Assurance Services was set up in 2009 and specializes in providing Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) Quality Assurance services to investigators. Services include:
- Consultation: General advice and assistance with GMP and GLP compliance issues.
- Auditing: Quality system audits.
- SOP Development: Assistance in development of Standard Operation Procedures (SOP) to meet regulatory and project-specific requirements.
- Batch Releases: Audit of batch manufacturing records and batch disposition for clinical trial materials.
- Training: Introductory presentations about GLP and GMP regulations.
Corinne P. Holman