Validation Statement

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:


Webinar recording: Digitalizing Quality Management System: How and Why? with Deloitte

Late November we’ve hosted a joint webinar with Deloitte on how you can and why you should consider digitalizing Quality Management System.

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Webinar with Deloitte: Digitalizing Quality Management System: How and Why?

November 21st, 17.00 CET we’ll have a joint webinar on quality digitalization with Vera Valesova, PhD, Senior Manager at Deloitte Risk Advisory/Life Science&Healthcare unit.

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11th Annual OCT Nordics 2023

We’re excited to announce our participation in 11th Annual Outsourcing In Clinical Trials Nordics 2023, October 24 – 25, Copenhagen, Denmark.

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KPI reports – get a complete overview of what’s essential at a glance

What’s usually been a whole collection of different graphs is now in one – and you can see when and if something goes wrong. 

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Have we picked your interest?

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.