Blog Flex Databases

May 19, 2026

Speaker Announcement Anna Petrovskaya at QA Virtual Conerence

Risk management used to live in spreadsheets, scattered documents, and endless review meetings. Not anymore 👀 That’s exactly what our QA Director, Anna Petrovskaya , will be speaking about at the International QA Virtual Conference .

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April 1, 2026

Risk-Based Monitoring (RBM) in Clinical Trials: A Comprehensive Guide to Modern Oversight

For decades, the clinical research industry operated under a manual, labor-intensive oversight model.

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March 18, 2026

What Will Inspectors Check in Clinical Trials in 2026?

Regulatory inspections in clinical research are evolving rapidly. As digital technologies reshape clinical trials, regulators are shifting their focus from procedural documentation to the integrity of the entire data lifecycle.

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December 2, 2024

Flex Databases Achieves ISO 27001 Certification

We’re pleased to announce that Flex Databases’ IT security measures are now formally certified under ISO 27001. This certification, earned after a thorough audit, demonstrates that our systems meet internationally recognized standards for information security.

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October 8, 2024

FDA Releases Guidance on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

In October 2024, the U.S. Food and Drug Administration issued a final guidance titled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers. https://www.fda.gov/media/166215/download

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June 8, 2023

How to stay a 100% compliant in a changing regulatory landscape, validation POV

There are some eternal values in regulated companies’ lives: GCP, 21 CFR Part 11, and computerized systems validation. However, even these are subject to change.

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March 24, 2023

Flex Databases compliance checklist for EMA Guideline on computerised systems and electronic data in clinical trials

Early March 2023, EMA has finalised and published the updated Guideline on computerised systems and electronic data in clinical trials. Here’s how we approach compliance to Guideline requirements:

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February 28, 2023

Challenges of bringing an international team together: an employee point of view

As we grow not only by numbers but also by the number of different nationalities in our company, we focus more on our internal cross-cultural communication processes.

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October 21, 2021

QA Director of Flex Databases to speak at 2021 international QA Conference

Our QA Director, Anna Petrovskaya, will attend #RQA2021 as a speaker. Date: 03.11.2021 Time: 19:30 Theme: Vendors Input into Computer System Validation Due to travel complications during the pandemic, Anna will be a part of the Virtual Meet the Exhibitors event.

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