The TRACERcenter Quality Assurance, Regulatory Assurance (QARA) program is a solution customized for your facility and to address regional regulations. The program is designed to help you set up a quality management system in line with Good Manufacturing Practices and with what is required for quality and regulatory compliance in your area. The QARA program consists of five modules:
Design Review: An onsite evaluation to determine if your facility is GMP compliant .
Quality Management System: Templates for Job Description, Quality Manual, Quality Management System (QMS) procedures, and Site Master File (SMF).
Facility and Process Management Qualification: Templates for URS (User Requirement Specifications), VMP (Validation Master Plan), IQ, OQ, PQ, raw material specification and SOP list, as well as operating, maintenance, and calibration SOPs for necessary QC lab equipment.
IQ/OQ Installation: Execute Installation Qualification (IQ) and Operation Qualification (OQ) for chemistry synthesizers, hotcells, and dispensing systems.
Generic Dossier: With a GE FASTlab* synthesizer, TRACERcenter QARA provides a template to assist in dossier preparation.