Each client will receive a full compliance package ready for use when audit. The package will contain:
Validation report (IQ, OQ and PQ)
Standard Operating Procedure (SOP) for usage of CLIN-LINK.
CLIN-LINK is validated according to GCP (R2) and GDPR using GAMP 5.
Installation Qualification (IQ) and Operational Qualification (OQ) will be performed to prove that the system has been installed as specified and intended and that the functionality of the system works. IQ and OQ will be performed by Signifikans according to relevant standard operating procedures.
Performance Qualification (PQ) will prove that the process, the system, and the users consistently produce results meeting the specifications. PQ is performed together with the client at the clients site.