Services / Audits & QA Consulting

AUDITS & QA CONSULTING

Investigación

Clinical research is supported by a complex regulatory framework led by the Good Clinical Practice (GCP), which covers all aspects involved in developing a clinical study.

The study-related procedures must be regularly verified to ensure that they are conducted following the applicable regulatory requirements for each participating member, and computer system from both the sponsor and third parties (vendors).

At Evidenze, we have highly qualified professionals to lead audits of all parts involved in a clinical study and the computer systems whose data is ruled by GCP and GMP.

Among the services offered by our Quality Assurance team are:

  • Vendor approval audits (GCP, GMP and GDP)
  • Audits of the file at the sponsor/CRO facilities
  • Audits of the investigator site file
  • Internal audits (GCP, GMP and GDP)
  • Audits of the GCP/GMP computer systems (GAMP 5 / FDA CRF 21 Part 11)
  • Training in GCP and audits
  • Consulting specialized in GCP quality systems