If this is cloud-based software, where is the data stored? Is it compliant with GDPR?
Amazon Web Services is our infrastructure provider, and the location of the data servers is in the EU, and it is compliant with GDPR.
How can you manage the QMS across multiple sites?
Within Scilife, you can use ‘Groups’ which define who can access and participate. You can have a harmonized QMS across sites sharing the relevant information and collaborating, but also segregating other parts that must remain independent to each site.
How can an IVD company be sure they have achieved a good quality mindset and that their QMS is robust enough?
To achieve a high level of quality maturity, an IVD company must adopt a holistic approach that integrates several key elements:
- Executive Commitment: At the heart of the organization is a steadfast commitment from leadership, reflected in clear quality policies, adequate resource allocation, and ongoing communication.
- Continuous Improvement: This is driven by regular audits, effective CAPA processes, and active employee engagement, ensuring that quality is constantly evolving.
- Risk-Based Approach: Every activity, from product development to post-market surveillance, should be grounded in a solid risk-based approach, ensuring proactive management of potential issues.
- Supplier Management: Maintaining strict supplier management is crucial to ensuring quality across the entire supply chain.
- Adaptation: Regular system reviews, coupled with support from Scilife’s team, enable the QMS to adapt to evolving regulatory landscapes and market demands.
