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:
We’re excited to share the latest enhancements across multiple Flex Databases modules, all designed to improve your efficiency, reduce duplication, and support better data consistency throughout your clinical operations. CRA Activity Management: SDV Log Tracker To improve source data verification (SDV) oversight, we’ve introduced a new SDV Log Tracker. This tracker pulls data from Subject […]
Clinical research is serious – but a little humor goes a long way. To celebrate International Clinical Trials Day, we’ve created a few memes that only researchers will truly appreciate. Because sometimes, laughter is the best medicine (after rigorous testing, of course).
An electronic Trial Master File plays a central role in maintaining oversight, ensuring regulatory compliance, and supporting successful inspections by health authorities. An efficient eTMF is no longer optional – it’s essential. Choosing the right eTMF model for your clinical studies directly impacts how effectively your teams can manage documentation, maintain version control, and collaborate […]
Smarter, Safer, and More Automated – Feature Enhancements Across Project Catalogue, CRA Activity Management, Pharmacovigilance, ST&I, and API. Project Catalogue: Smarter Subject Tracking with Randomization Logic We’ve added a new toggle to project settings: “Randomization of the Project”. You can now define whether a project is Randomized or Non-Randomized, helping the system adapt how it […]
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.