M.A.R.C.O. GmbH & Co. KG

Quality View
Philosophy
QM-System
Compliance with
International Standards

Compliance with International Standards, Guidelines and Requirements

1. ICH - GCP

Our in-house processes are in accordance with the respective ICH guidelines. In our processes the fundamental ideas of GCP and the Declaration of Helsinki are always kept in mind.

2. FDA 21 CFR Part 11

Data management procedures were established at M.A.R.C.O. taking note of the requirements as expressed in the FDA Guideline 21 CFR part 11:

An "automatic audit trail" with regard to the administration of access rights to project files is implemented.

3. Validation of Computerized Systems

M.A.R.C.O. is taking note of the requirements as expressed in:
- Computerized Systems Validation in Clinical Research, 2nd edition

(Association for Clinical Data Management).
- GAMP 4 - Guide for validation of automated systems (ISPE 2001).

4. ISO 9001

Our quality management system is based on the DIN EN ISO 9001.