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Published on September 09, 2015

Castor complies with all applicable laws and regulations with regard to ICH Good Clinical Practice (GCP) and the General Data Protection Regulation (GDPR). Following an audit – and improvement process we have been awarded a GCP compliance statement. Please find below the official notification issued by Profess on obtaining this certificate.

Source: Profess Medical Consultancy B.V. 

Profess Medical Consultancy B.V. has performed a system audit at the offices of Ciwit B.V. (Castor EDC’s parent company) and has issued a GCP compliance statement. The purpose of this audit was to determine if Castor EDC’s data management system had complied with all applicable laws and regulations and had been validated correctly. These applicable laws and regulations are the ICH GCP Directive and the General Data Protection Regulation (GDPR).

Obtained GCP compliance statement Castor
GCP compliance statement

 

At the time of the audit the Castor EDC system included 500 studies (at the time of writing this number had increased to 600). Profess subjected the quality system to a critical analysis. The managing director (doctor/ epidemiologist) and the head of the development team were interviewed on the quality system’s implementation and the development process in relation to the new functionalities within Castor EDC.

The evaluation identified that a number of required Standard Operating Procedures (SOPs) had not been set up yet and that responsibilities could be described more specifically. Organisational coordination, such as updating training records, could be improved, as well as the risk mitigation documentation. The auditors confirmed that the product development followed the V-model lines for System Life Cycle Development, which includes the proper implementation and documentation of the necessary performance – and acceptance tests.

Castor would meet the requirements if the shortcomings identified would be resolved. To this end, Ciwit and Profess draw up a list with so-called CAPAs (Corrective Action Preventive Actions).

Ciwit worked towards resolving all CAPAs and subsequently Profess performed a follow-up audit. On July 24 2015 Profess concluded that the entire quality system complied with both the applicable laws and regulations and GCP, and that it was implemented correctly. This resulted in issuing the GCP compliance statement, as you can see in the picture above.

We have noticed that the quality system now drives the organization and is providing added value for Ciwit.