Products
CTMS
eTMF
AI in eTMF
DMS
Project Management & Budgeting
Pharmacovigilance Software
LMS & QMS
Blog
Clients
Our Clients
Why Clients Choose Us
Pricing
Implementation
Compliance
Company
Contacts

LMS & QMS

Quality Management System & Learning Management System modules can be used together, separately or with other modules on our platform. Centralized and automated management of trainings and all quality-related activities.

Download Product Sheet
compliant with FDA
ISO 27001_2022

Streamline all QMS processes in one system

  • Manage SOPs, audits, incidents, and CAPA with QMS
  • Initiating CAPA review, planning, and resolution
  • Managing any type of audit – internal, external, vendor, etc. – from planning to CAPA tasks resolution and observation period
  • Registering and tracking any incident & its resolution, severity, and impact evaluation
Product Sheet PDF
Inbox

Inbox

Create task

Create task

CAPA Management

CAPA Management

Build up your dream system – your needs is the limit

  • Create your own flow for any activity in the system: QMS documents, audits, CAPA, or incident
  • Build up you own views, fields, and activities in the system
  • Upload your templates and generate pre-audit and audit follow up letters as well as audit plan, report, and certificate in the system
Product Sheet PDF
QMS workflow

QMS workflow

QMS activities

QMS activities

Make training process easy and fun with Flex Databases LMS

  • Choose from several training types: courses, self-trained, or trainer-led
  • Run post-training quizzes to check your employees’ knowledge
  • Add videos, presentations, links, and documents to your training
  • Training library is available for employees, as well as library of SOPs and other standard documents and company templates
  • All problems with training are accessible in one click
  • Get a clear simple picture on any outstanding training of project team members
  • Deep business intelligence reporting for all training matters – besides all basic reports you can even see how long it took to answer a specific question in a training quiz
Product sheet PDF
Dashboard

Dashboard

Course creation

Course creation

Content creation

Content creation

Organize simple onboarding & qualification check-up

  • Set up your own training matrix with automated training assignments and comprehensive completion reports
  • Get a clear picture of your employees’ training completion and knowledge gaps
  • Troubleshoot with subordinates’ training – transparent picture of all training and problems of employees
  • Easy scaling and integration of new companies or teams into corporate culture with simplified onboarding
  • Flexible notifications not to forget about a training, to review and update an SOP
  • Access for different levels of employees and external users – QA view, training manager view, line manager view, project manager view, employees view
Schedule

Schedule

SCORM

SCORM

User Area

User Area

Features

Inbox
  • Initiating CAPA review, planning, and resolution
  • Assigning responsible team members to tasks and process steps
  • Tracking all responses and progress of CAPA
  • CAPA observation period, scheduling and tracking
  • CAPA effectiveness tracking and evaluation
  • Document generation and sign-off
  • Action implementation evidence
  • Various KPIs tracked, performance measured on company level and per project
CAPA Management
  • Audit planning and scheduling
  • Any type of audits: internal, external, vendor, etc
  • Full audit lifecycle from planning to CAPA tasks resolution and observation period
QMS workflow
  • Any incident is registered and tracked
  • Incident severity and impact evaluation
  • Tracking the incident resolution, including actions, and timelines
  • Making decisions about the necessity of CAPA based on assessment
QMS activities
  • Create a new QMS document or initiate review
  • Review cycle of documents with comments, revision history and electronic signatures
  • Transparency in review process with reporting on steps of review, responsible employees, and timelines
Dashboard
  • Electronic employee training records
  • Completion confirmation with e-Signature
  • Management access to training records to ensure training completion
  • Ability to view images and pdf files in browser without downloading
  • Optional training library
Content creation
  • Reports and statistics on training results
  • Comprehensive reports on assigned and completed training, trainer assessments, line manager comments, completion report generation etc.
  • Automatic system of notifications and completion report generation
  • Automatic alerts to employees and their supervisors on assignments & overdue trainings
  • Ad-hoc reporting tool for cross-project and cross-module reporting (graphs, widgets)
Course creation
  • Training and QMS matrix management
  • Centralized assignment for any group: e.g., department, position, project, country
  • Default assignments in accordance with a training plan
SCORM
  • Upload images, pdf files, videos of any size, links to external resources, or other documents as training materials online
  • Individual quizzes may be created for any training with different types of questions
User Area
  • Corporate SOP library management
  • SOP lifecycle management

What They Say About Us

Tameo Kobayashi

Chief Innovation Officer, Director, Business Innovation Dept., CMIC HOLDINGS Co., Ltd.

Flex Databases system is very flexible and user friendly. In addition, most importantly the team have much much flexible ways of thinking! I am very proud that we did choose Flex Databases as our platform in CMIC APAC offices.

Joshua Baisley, H.B.Sc.

VP, Clinical Design and Delivery

As we have begun the installation process for Flex Databases system for use with the Clinical Trial Management group, the team at Flex Databases have made this process efficient and organized along with answering any questions that come up internally and jumping on additional meetings with our team to ensure that everything is understood throughout the set up and training process.

John Douglas Snowden

Senior Vice President of Technology Innovation at NCGS, Inc.

NCGS has partnered with Flex to utilize nearly the entire suite of cloud-based modules Flex has to offer for the industry. NCGS believes in Flex’s vision for their platform as it so closely ties to our own ideals of uniformity and simplicity in operations and the delivery of true quality.

Craig Winter

CIO, Agenus Inc.

I have been with Agenus for over 26 years. Over those 26 years, our Flex CTMS and TMF implementation is the smoothest and fastest implementation of a validated IT system we have done.

Cheryl Marron

Manager Clinical Operations

We were searching for a flexible yet straightforward eTMF solution for one of our biotech clients. We have been working with Flex Databases for our internal project management and budgeting and their eTMF solution also convinced us. The Flex Databases team was incredibly helpful with setting the system up in no time.

Ulrike Schorr-Neufing

Director Personnel & Qualification

We have been using Flex Databases software for about 2.5 years now. One major advantage of Flex Databases CTMS is the ability to create specific reports ourselves. Additionally, we value that our feature requests are taken seriously by Flex Databases and added to their development roadmap. We also benefit from their customer-specific configuration service.

Martin Krauss

Director of FGK Clinical Research

FGK selected Flex Databases for CTMS and TMF due to clear structure, intuitive interface, flexible investigator payment module, offline access for CRAs, and positive cooperation with the Flex Databases’ team.

Simon Rückinger

Managing Director at Metronomia Clinical Research GmbH

We were searching for a flexible yet straightforward eTMF solution for one of our biotech clients. We have been working with Flex Databases for our internal project management and budgeting and their eTMF solution also convinced us. The Flex Databases team was incredibly helpful with setting the system up in no time.

Maya Bhattacharya

Manager, Global Regulatory Affairs Operations

We knew Flex Databases was a game changer, providing confidence to what we could do next within the Clinical space, considering our trials/patients. SPARC choose Flex Databases due to system flexibility and checking the boxes for ALL of our major requirements. We also wanted the latest and greatest technology considering the long-term advantages of having one solution with the increased possibilities of integration.

Lídice Vidal

Chief Clinical Օperations Officer

We have made a journey of almost two years now, since we were exploring new vendors to change our CTMS system in May 2022, until the deployment of the system last March 2024. It would not be possible without the kind and patient support of Flex team! All the team we have encountered during this time have listened attentively to our needs and doubts, have perfectly understood them, and have always provided us with new options and possible solutions.

Have questions?

Drop us a line and we be happy to answer all your questions

100+

Clients

20 000+

Daily users

10M+

Documents

2 000+

Clinical trials

30+

Countries

More about LMS & QMS

Streamline learning management of any scale with Flex Databases LMS
June 1, 2023
Streamline learning management of any scale with Flex Databases LMS

When working in a regulated industry, learning management is a huge concern since the need to follow SOPs & complete training applies to all company employees (at different levels, but still). It’s complicated enough when we think of dozens of people split between dozens of roles, but what if it comes to hundreds or thousands? […]

Learn more
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 […]

Learn more
Achieving compliance, streamlined training, and transparency in SOPs management with LMS
October 27, 2021
Achieving compliance, streamlined training, and transparency in SOPs management with LMS

Nowadays, Learning Management System (LMS) acts as a virtual hub that helps not only with documentation, administration, reporting, tracking, delivery, and automation of training but mainly with audits and SOPs management.  LMS has some crucial business benefits:  There are tons of things to consider when it comes to choosing the right Learning Management System. Let’s take a […]

Learn more
What’s next for Flex Databases Learning Management System?
March 11, 2021
What’s next for Flex Databases Learning Management System?

It’s been two years since our How to stop worrying and start working in clinical trials material dropped. Content-wise, it was the highest point for our Learning Management System so far. I have to admit, since then, we kind of abandoned its storytelling activities and just sometimes briefly mentioned new developments for LMS in our release notes. […]

Learn more
See all the stories

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.