GCP and GLP Auditing

With over 25 years of experience in GCP/GLP auditing all main types of audits are performed.

Audit targets include:

  • Investigator-sites, electronic/trial master files, clinical study reports, databases
  • Vendors: CROs, pk- and clinical laboratories, providers of central reads, warehouses and logistics including coverage of computerized systems and validation aspects
  • Process/system audits: Assessments of compliance and efficiency for further improvement

Areas of auditing include full GCP, GLP laboratories, GMP Annex 13 and medical devices (ISO 13485/ ISO 14155). Additional areas of expertise are offered via CQC´s network of consultants.
CQC works according to own SOPs or on basis of the client´s standards. Most types of audits can be performed as remote audits in accordance with CQC SOPs and/or client´s SOPs.