Stay Compliant, Stay Confident

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.

Validation as a service

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.

Validation deliverables

We provide all the necessary documentation to be included in the Client’s validation package:

  • Validation Summary Report for all our validation efforts as system developer
  • User Requirements Specifications
  • OQ Testing Summary Report
  • User Manual
  • Release Notes
  • IQ documentation
  • Maintenance Plan
  • Training Certificates
  • And we do provide the necessary documents ensuring you are aware of and control all the changes implemented into the system after the first release to production.

Your Success Is Our Priority

As your trusted partner, we offer comprehensive services and deliverables for streamlined GxP-regulated system validation.

  • Formalized User Requirements Specification (URS) compliant with 21 CFR Part 11 for e-records and e-signatures
  • Deployment of Client’s private cloud instance with Installation Qualification (IQ) documentation
  • Training in accordance with our Quality Management System, industry standards, and applicable regulations
  • Updated validation documents with every new system version release, adhering to risk-based approaches recommended by industry standards

Global Reach, Top Performance

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.

Let’s Accelerate Your Validation Journey

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.

Your Audit-Ready Partner

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 to embark on a seamless validation journey with Flex Databases.

Learn more about regulatory recommendations regarding validation with these valuable resources:


Stallergenes Greer logo
Stallergenes Greer Chooses Flex Databases eTMF to Enhance Inspection Readiness and Oversight Efforts

Stallergenes Greer, a global healthcare company specializing in allergy diagnosis and treatment through allergy immunotherapy (AIT) products, has chosen Flex Databases as its eTMF vendor. The answers were provided by Virginie Lobrégat-Duriez, Director of Clinical Operations, and Dominique Jouny, Senior Clinical Project Manager. Q1. What did Stallergenes Greer have to start looking for an eTMF […]

Learn more
AI eTMF Webinar
Webinar with Deloitte | AI in eTMF – Auto-Classification and Metadata: Efficiency and Compliance

Join us for an exclusive insightful webinar as we explore Artificial Intelligence (AI) within the Electronic Trial Master File (eTMF) system. Explore how AI can transform document management, simplify processes, and maintain compliance with regulatory standards. What to Expect? Have burning questions about AI implementation in eTMF? This webinar offers the perfect opportunity to have […]

Learn more
AI validation for life sciences – a unique challenge of dynamic nature

What aspects need validation to ensure confidence in AI-driven processes, and is it possible to achieve 100% certainty?

Learn more
how we implenented eTMF
How we implemented eTMF & developed SOPs in 3 weeks for iRenix

And here’s the twist – while iRenix was laser-focused on their operations and study start-up processes, we rolled up our sleeves to deliver a full-on, turn-key eTMF setup from scratch.

Learn more

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.