A land before time: how LMS enables your QA and Training teams to save time and be ready for any audit

September 7, 2022

A land before time: how LMS enables your QA and Training teams to save time and be ready for any audit

Do you remember when each new SOP or an update of an SOP required your QA and Training Teams to send out the emails to the employees? The days when everybody had to print and sign the acknowledgment forms? And then, the poor QA and Training Teams were to file the forms manually.

It seems like something from the dinosaur era, but it is still true for many small and mid-size companies that have not implemented LMS. 

Let’s see how the learning management process looks for QA and Training Team with no LMS in place and assess the number of possible mistakes:

  • Step 1: Determine the list of employees required to pass the training and email them manually. It should not take much time, though if you don’t have an employee training matrix in place, you risk simply forgetting somebody.
  • Step 2: The most exciting part – all trainees are supposed to send a signed acknowledgment form back, but there is little to no option to check if the employees genuinely read and understood the procedure. Unfortunately, it could become a problem during an audit, especially if you have over 100 employees.
  • Step 3: Check who has sent the form back and who hasn’t. Then remind the ones who have not to go through the SOP and collect the acknowledgment forms back. Indeed, it all depends on the number of trainees, but it might take a while if it is the whole clinical department or several departments, or in the worst-case scenario, the entire company.
  • And all this time QA and Training Team would be buried under an avalanche of reminder emails, received forms & the need to have the task in mind constantly…
  • …but this is not the end of the horror. When you receive a notice of an upcoming audit or inspection – it’s time to get back to training completion forms, list missing ones, and reach out to those who missed the training.

As a result – weeks spent on routine, manual, and not that exciting tasks, QA & Training teams spend time managing papers instead of working on more important things. 

How could an LMS help?

It shouldn’t be an overcomplicated enterprise solution but an efficient and user-friendly tool. For example, Flex Databases LMS provides you with the following:

  1. Fast and straightforward training creation with an option to add quizzes, assuring the employees indeed went through a training and understood the core importance of its contents
  2. Transparent training matrix – assignment of the training to predefined groups of employees: by roles, countries, projects, etc., so you don’t have to worry about losing somebody any more.
  3. Configurable & recurrent training notifications – the system will send reminder emails to the training assignees until they finally pass it.
  4. E-signatures and online training certificates generated by the system meet all the regulatory requirements
  5. Immediate access to the list of the employees with overdue training – allows you to troubleshoot in seconds and prepare for an audit many times faster. 
  6. All training & qualification data is stored in one place with secure yet quick access – so you stay audit-ready 24/7

Here at Flex Databases, we believe in the power of routine automation. So you can free your employees’ hands and minds for important, challenging, and fun things without losing track of important documents & processes. Let us show you how it works by requesting a demo through bd@flexdatabases.com or a Request demo form, and we can start automating your processes immediately. 

Blog

August 28, 2025
Integrations in Clinical Trials: An IT/ETL Perspective

How Flex Databases connects your study ecosystem – reliably, securely, and at scale.  Why integrations matter to sponsors and CROs  Integration means that data entered once in a system of record is propagated automatically wherever it is needed. For clinical operations teams this translates into:  Core integration patterns we see most often  1) EDC → […]

August 14, 2025
Key Changes to EU Pharmacovigilance Regulation: What You Need to Know

In July 2025, the European Commission adopted Commission Implementing Regulation (EU) 2025/1466, amending Regulation (EU) No 520/2012. The changes aim to strengthen pharmacovigilance, reduce unnecessary administrative burden, and align EU requirements with global best practices. Most provisions apply from 12 February 2026, with certain Eudravigilance updates taking effect in August 2025. Why the Changes Were […]

July 31, 2025
How Much ROI Can You Expect from eTMF and CTMS? 

A Comparative Look at Europe vs. US Markets  In clinical operations, time is money – but how much money can technology really save you? We analyzed the return on investment (ROI) for implementing electronic Trial Master File (eTMF) and Clinical Trial Management Systems (CTMS) based on real-world benchmarks. By modeling savings from reduced manual effort, […]

July 29, 2025
The Flex Databases team is looking for a QA Engineer / Tester. 

📍Remote 💼Full-Time We are driven by our high mission to make an impact in the Life Sciences industry. We provide flexible e-Clinical software systems for Clinical Research Organizations (CROs) and pharmaceutical companies.  We work globally with clients all over the world, with our own offices located in the Czech Republic, Switzerland, Turkey, and the US. […]

Contact us

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.