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:
📅 September 24 | 3 PM CET🎥 Beyond the Binder: Inspection Readiness in the eTMF Era👉 Register here: https://lnkd.in/dnbpUKYY Being inspection-ready is not just about having 100% full eTMFIt’s about knowing what happens before, during AND after an inspection. On September 24 at 3 PM CET, we’re bringing together two experienced clinical research professionals: 🎙️ […]
Flex Databases team is looking for a DevOps/Infrastructure Engineer who can approach infrastructure with intelligence and pragmatism.We have operational systems, mission-critical services, and a ton of interesting challenges. What we’re looking for: • 3+ years of hands-on experience in infrastructure administration, DevOps, or a similar technical role.• Strong practical experience with Windows and/or Linux server […]
Every pharmacovigilance case tells an evolving story. A case rarely arrives once and stays static – new information keeps surfacing after the initial intake: a patient is hospitalized, a birth date gets corrected, a new reaction is reported, a concomitant medication comes to light. For safety teams processing cases from clinical trials, marketed-drug consumer reports, […]
FluoGuide lights up cancer to maximize surgical outcomes in oncology and its lead product, FG001, is designed to improve surgical precision. FluoGuide is listed on Nasdaq First North Sweden under the ticker “FLUO”. (Q) What clinical trial management challenges led you to seek a new system? Our main challenges were inefficiencies caused by disconnected systems, […]
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.
