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SliceVault Express

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,

  • service provision,

  • 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.

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