Assessment GCP Compliance
Profess performs GCP and ISO 14155 Compliance Programmes for Research Institutes and R & D departments of the pharmaceutical and medical device industry in full cooperation with the clients’ QA group. We have established the following methodology:
- Conduct a pre-audit to evaluate the current status (GAP analysis)
- Advise and propose action plans based on the findings
- Advise and give operational support in order to implement the changes
- Evaluate the new situation at regular intervals
- Document the results of the project in a final report
We can also assist the QA group with the development of SOPs. We build custom-made quality systems that are compliant with ICH GCP and ISO 14155 standards and the applicable regulatory requirements. Optional is to build that quality system in HTML version on the clients’ intranet making the system more userfriendly. Moreover the maintenance of such a system is more simple and state of the art.