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. meeting 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 5 - A Risk-Based Approach to Compliant GxP Computerized Systems
4. ISO 9001
Our quality management system is based on the DIN EN ISO 9001.