FAQ GxP Compliance

Below you find the most frequently used questions regarding compliance within ELPRO Cloud.

 

Table of Content
  1. Is ELPRO Cloud GxP-compliant?
  2. Is the ELPRO Cloud software developed following the GAMP5 model?
  3. Is ELPRO Cloud part of the ELPRO Quality Management System and therefore ISO 9001 accredited?
  4. Are there any templates to support my qualification of ELPRO Cloud?
  5. Is it possible to get a test/validation account for major updates?

  6. Is it possible to qualify ELPRO as a supplier?

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.

Is it possible to get a test/validation account for major updates?

Yes, for major updates ELPRO can provide an account to the new software version of the platform upon request, independent of the productive instance and prior to the update of the productive instance in order to allow for testing and customer side validation of the new version. These test/validation accounts may be at extra cost (hardware configured for the testing instance can be purchased at the same price as regular hardware). Test accounts are available 30 days prior to the major update and will only be available for a limited time. For minor updates, there are only upgrades/changes in functionality that are not affecting existing functionality and/or new functionality that is not affecting existing functionality. Hence, for minor updates no changes in processes and upgrade/change in customer's validation and qualification documentation are needed.

Is it possible to qualify ELPRO as a supplier?

Yes, we are providing you with our standardized quality assurance documents. The self-assessment contains detailed information on ELPRO. This document is version controlled and is updated regularly. Therefore, please understand that due to limited resources, we plan these into the improvement of our solutions and products and cannot answer individual questionnaire sheets. Our self-assessment questionnaire thoroughly describes ELPRO’s quality system, software development, compliance with the ISO 9001:2015 and ISO 17025:2017 Standards. We are confident that all of your questions will be answered by our self-assessment; please file a ticket here to request the self-assessment questionnaire.