Below you find the most frequently used questions regarding compliance within ELPRO Cloud.
Last Updated: September 08, 2020
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Is ELPRO Cloud GxP-compliant?
Yes, ELPRO Cloud is developed to meet the requirements of the pharmaceutical industry and if fully GxP-compliant:
- ELPRO has an ISO 9001 accredited quality management system
- All components (Hard- and Software) are developed following the GAMP5 model
- ELPRO Cloud has a user management system keeping track of all interactions in an audit trail
- The sensors have an accuracy of <0.5°C and are calibrated in an ISO 17025 accredited laboratory
- All changes, including the ELPRO Cloud SaaS, are controlled by the stringent change management process
Is the ELPRO Cloud software developed following the GAMP5 model?
Yes, like all components, the ELPRO Cloud application is developed and documented according to the GAMP5 model.
Is ELPRO Cloud part of the ELPRO Quality Management System and therefore ISO 9001 accredited?
Yes, all components are developed and tested following the GAMP5 model. On top of that, the operations of the ELPRO Cloud application is managed by ELPRO using documented processes to build, control and maintain the SaaS (Software-as-a-Service), too.
Are there any templates to support my qualification of ELPRO Cloud?
Yes, we do support customer qualification with a template to perform the qualification. Please submit a ticket if you want us to send you the template.
Can I audit ELPRO?
Based on a Non-Disclosure Agreement (NDA), ELPRO issues a detailed audit questionnaire to ELPRO Cloud customers. The questionnaire gives answers to questions around development, architecture, security and maintenance of ELPRO Cloud as well as the entire Quality Management System of ELPRO. File a ticket here to request the NDA.