You organize clinical trials (drugs) or clinical investigations (medical devices)?
You need to audit your central labs, anywhere in the world?
You need to ascertain the quality, reliability, integrity and compliance of your laboratory data?
CQS and ALP Quality Systems join their competencies and experiences to propose an innovative audit approach.
We offer to assemble audit teams that have demonstrated expertise to assess the technical and scientific capabilities of laboratories and audit against ISO 15189 (ISO Quality System for Medical Laboratories), GCP (ICH E6), GCLP and 21CFR11.
We have integrated these requirements and referential into a single audit guideline, that enable us, after a single audit, to provide you with a robust and reliable quality audit, than can fulfil the vast majority of regulatory and standard requirements worldwide.
We can audit central laboratories involved in Clinical Pathology, Cytology & Anatomo-Pathology, and Bioanalysis.
Our audit teams are fluent in French and English. Audit reports will be delivered in English.
Audit guidelines and findings grading and classification are standardized; however we can consider sponsor specific customization.