14audit
Global Audit Library — a subscription library of third-party GMP audit reportsdescribed by the company as covering more than 2500 individual products with three-year report validity. Computer systems validation and data-integrity servicesincluding TrackWise implementation support.
Rephine states on its About page: "We achieved ISO 9001:2015 Certificationthe world's most recognised quality management standardfor our UK (Stevenage) and Spain (Barcelona) teams." It also states: "Rephine Barcelona S.L. is now accredited to ISO/IEC 17020 as an inspection body for specific GMP and GDP audit activities." Audit and consultancy work is described against EU GMP (including Annex 11 and Annex 15)ICH Q7/Q9
REG 20ENG 100 reviews