Quality Management System (QMS)
The de-identification process is the process by which SliceVault de-identify medical images locally before data is transferred via secure communication to SliceVault servers. The de-identification process ensures all images are free from Personal Health Information (PHI) before being committed to the online trial repository.
Last updated: 4 January 2023
ISO 9001 is an international standard for quality management systems. SliceVault's QMS is designed to conform with this standard.
Having a quality management system in place that is designed to conform with the standard is a testimony to our capability to ensure continued service consistent with the requirements of our clients, which greatly contributes to client satisfaction.
When designing and implementing our QMS, we developed a range of dedicated standard operating procedures adapted to the needs of clinical trial sponsors, imaging CROs and other organisations from the medical and pharmaceutical sectors engaged in imaging-based clinical trials. Our procedures regulate software development and release, data backup and retention, incident response, vendor recruitment, and complaint handling, among others.
Our QMS covers the following areas:
software development, maintenance and release,
change and risk management,
auditing and management reviews,
human resources and vendor management,
customer satisfaction monitoring and complaint handling,
detection and recording of non-compliance incidents and implementation of corrective measures.
Clients are welcome to conduct client audits, and we also regularly implement internal audits.
The benefits of having in place a QMS include:
validating SliceVaults dependability as a provider of imaging data management services,
ensuring consistent, reliable performance of our software services,
implementing procedures with improved governance adapted to the needs of the clients we work with.