Flex Databases Platform is designed to help our Clients to work securely with their data and deliver it to users, customers, and partners, and to drive better business outcomes. Flex Databases protects Clients’ data, ensure the following security regulations, and mitigates all potential risk which is essential to building trust and delivering the high level of service. Flex Databases takes a risk-based approach to security, and this page details the measures and technologies implemented to protect our customers.
Our security implementation allows us to adhere to the following standards and best practices, demonstrating our commitment to customers’ security and privacy:
As a SaaS provider Flex Databases pays great attention to the safety of the data on all levels. We use only the best scenarios and industry practices to keep and protect customers’ data: from physical security at the data centers to full control using audit trail at the data level:
To maintain a robust disaster recovery strategy, backups are retained at separate Flex Databases data centers at a geographically different location within the same region as the primary data center, with the same level of physical and infrastructure security described above, to maintain a robust disaster recovery strategy. All backups are encrypted-in-transit to the separate data center and are encrypted-at-rest while stored at that location. We are in the total charge for the security of data; that’s why we use the best experience in data storage and backup technology.
If you have any questions, regarding our security policy or any other questions, send us an e-mail at contact@flexdatabases.com
In today’s regulatory landscape, software validation is not just an option — it’s a necessity. Validated software is a key requirement, mandated by regulatory bodies like the WHO Expert Committee on Specifications for Pharmaceutical Preparations and the EMA Guideline on computerized systems and electronic data in clinical trials.
At Flex Databases, we understand the importance of compliance and accuracy in clinical trials. Our validation process ensures that all computerized systems used within a clinical trial consistently meet specified requirements, ensuring reliability and intended performance throughout the product’s lifecycle.
We happily apply our hassle-free, quality-driven validation experience to support our clients. Our expert team follows best practices, aligning with regulatory guidelines. The validation methodology is based on GAMP® 5 guidance. We employ an Agile & SCRUM approach, frequently updating our systems to keep pace with industry trends and regulatory changes.
We provide all the necessary documentation to be included in the Client’s validation package:
As your trusted partner, we offer comprehensive services and deliverables for streamlined GxP-regulated system validation.
Our data centers, located worldwide, are handpicked from an approved vendor list. This strategic approach not only ensures regulatory compliance but also guarantees stable performance. For EU-based clients, we offer data centers in Germany and Finland, and US centers for our American clients. All the centers have successfully passed the vendor-assessment audits and comply with personal data protection regulations.
We believe in making the validation process smooth and efficient for our clients. Our team is ready to guide you through the system during your user acceptance testing (UAT), providing the necessary documents to ensure your success.
Flex Databases’ Quality Management System (QMS) covers all processes, supporting vendor assessment with a comprehensive range of documents, ready for your audit needs. We’ve successfully passed numerous external audits by esteemed international CROs, pharmaceutical companies, and independent auditors.
Reach out to contact@flexdatabases.com to embark on a seamless validation journey with Flex Databases.
Learn more about regulatory recommendations regarding validation with these valuable resources:
What is CTMS A CTMS – Clinical Trial Management System is a software solution that facilitates more streamlined management and monitoring of clinical trials. Clinical operations teams like project managers, CRAs, and study coordinators in pharmaceutical firms, CROs, and biotech firms use the tool to oversee everything from site selection and subject recruitment to monitoring […]
Dana Leff Niedzielska, MBA, SVP of Global Clinical Operations at Everest Clinical Research, shares her experience using Flex Databases’ CTMS and eTMF. In this interview, Dana highlights how Flex Databases supports Everest CRO’s clinical operations. Learn why Everest chose Flex Databases as their trusted technology partner and why they continue to rely on and trust […]
Pre-Validation for CRA Reports The Monitoring Activity report tab now features a validation preview. Users can check for missing fields and review validation messages before generating the final report – enabling more accurate submissions and reducing the need for rework. Bulk Imports for Milestones and Assumptions You can now bulk import project milestones and assumptions […]
The countdown is on – ICH GCP E6(R3) is about to go live in the EU, and everyone’s getting prepared! As a service provider (you caught that new R3 definition during training, right?), Flex Databases is here to support you through the transition. Let’s highlight a few areas that are especially important for our clients: […]
Get in touch to discuss compliance, implementation, demos, pricing
We are here for all of your questions! Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.