Wolfratshauser Str. 76B
82049 Pullach
T | +49 (0) 177 4475900

info@clinqm.de

The regulatory environment conducting clinical studies with medicinal products and medical devices are strictly regulated. As well as analysing human biosamples in laboratories.

Defined written procedures, e.g. SOPs and Working Instructions should ensure that all related activities are performed respecting applicable guidelines and legal regulations. Compliance with the Quality Management System will be checkerd by Audits on regular basis.

Electronic study data must be handled in compliance with suitable regulations (e.g. 21 CFR Part 11, GAMP, PIC/S). Therefore, systems and applications for electronic data capture (EDC), processing, storage and archiving must be validated to ensure that, e.g. changes on electronic date are only possible if these are documented and tracked (e.g. Audit or Edit Trails). Data security and data protection of all trial documents and study data must be guaranteed.