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F.A.Q.

1. Where will be my Data Center?

We have a list of prequalified Data Centers according to our SOPs as we have clients all over the world, location of servers and backups are agreed and reflected in the Service Level Agreement. Exact Data Center location depends on the Client’s requirements. Currently, we work with Data Centers in Germany, the USA, Singapore, and Australia. For more details, click here.

2. What about compliance?

Flex Databases System is compliant with all major international and local regulations, such as:

  • ICH GCP E6 R2
  • FDA 21 CFR Part 11
  • GDPR
  • EudraLex Volume 4 Annex 11
  • PMDA
  • NMPA
  • HIPAA

Flex Databases is audit-ready: we are always ready to pass on-site or remote audits and fill in any questionnaire from your QA. We’ve successfully passed many customer audits and even have shared audits experience.

3. What is the Flex Databases pricing model?

We provide subscription-based software. Clients pay monthly or quarterly based on the number of users and the number of modules in the contract. A number of projects and sites is unlimited.

4. Who are your customers, and where are the references?

We have different types of customers all over the world, from boutique CRO’s to key pharmaceutical market players. At our Clients page, you can find the selection of our Clients and some references quotes in “What customers say about us” section. More references are available on Capterra and upon request to bd@flexdatabases.com.

5. What are Implementation timelines?

Estimated timelines for implementation are from 3 to 10 weeks, depending on the complexity of Client’s requirements.

6. What happens if we decide to terminate the contract?

We don’t ask our clients for a lifelong commitment: contract termination notice period is only 90 days. The contract will be terminated, and all Client data transferred to the client.

7. How is training performed?

Flex Databases system is a professional system; trainings are required for productive work with the application. Trainings are performed during the implementation period online and Face-to-Face depending on the scope of implementation. Clients receive video and printed materials and usually take on responsibility for further training of new employees in the future.

8. Can the system be configured or customized?

The baseline system is very flexible for client-specific configurations at no additional cost: different flows, configurable trackers, templates, reports. And in case the system can’t make Client happy within configuration capabilities, we can perform customization of the system as per Client’s requirements.

9. How do you manage updates?

Updates for baseline system are provided for free. We do not pressure our clients into updates and support all systems versions. Before the update or any changes to the client’s environments, we confirm it with the client.

10. What about validation?

We provide validation certificate for core functionality, installation qualification documentation and end-user validation support (User Acceptance Testing scenarios for GxP modules of the system and Configuration Requirements Specification, where applicable). You can read more on our Validation page.

11. What do I need to use the system?

Internet access and any browser out of Chrome, Opera, Firefox, Internet Explorer > 9.0, or Edge.

12. Is your system secure?

Flex Databases Platform is designed to help our Clients to work securely with their data. All data is encrypted, and backups are performed according to GFS rotation. For Clients’ installations, we always have at least two Data Centers located in different cities or even countries to mitigate risks of data loss.  We protect Clients’ data, ensure the following of security regulations, and mitigate all potential risks, which is essential to building trust and delivering a high level of service. You can read more on our Security page.