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:
About Integrated Therapeutic Solutions Integrated Therapeutic Solutions (ITS) is a clinical research organization conducting multi-country clinical trials and supporting post-marketing needs across a growing sponsor portfolio. As case volumes increased, so did the complexity of managing pharmacovigilance activities from safety event intake and workflow tracking to regulatory reporting and cross-functional coordination with clinical operations teams. […]
Clinical industry has finally embraced AI, sponsors run decentralized trials and data is now collected in real time. But still one of the most critical workflows in every study – handling adverse events (AEs) – surprisingly depends on copy-paste. Most sponsors assume that if they have an Electronic Data Capture (EDC) system and a Pharmacovigilance […]
The pharmaceutical industry faces a familiar paradox: the tools that promise to make regulatory compliance faster and smarter also introduce the most complex new compliance questions. Nowhere is this more visible than in AI-powered Trial Master File (TMF) management. At Flex Databases, we have developed a validation framework rooted in GxP principles, risk-based thinking, and […]
AI in Trial Master File management has quietly stopped being a someday idea. It’s not a pilot and it’s not a roadmap promise – it’s something clinical teams reach for on an ordinary Tuesday. The interesting part isn’t that AI can file a document; it’s how calmly and predictably it does it now – with […]
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.
