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.

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
Create task
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
QMS workflow
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
Course 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
User Area


QMS: CAPA management

  • 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

QMS: Audit 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: Incident management

  • 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: SOPs and other quality documents

  • 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

LMS: General

  • 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

LMS: Reports & notifications

  • 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)

LMS: Training types

  • SOPs, self-trainings, and classroom trainings
  • Recurrent trainings

LMS: Training assignment

  • Training and QMS matrix management
  • Centralized assignment for any group: e.g., department, position, project, country
  • Default assignments in accordance with a training plan

LMS: Supported types of files

  • 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

LMS: SOPs management

  • Corporate SOP library management
  • SOP lifecycle management

What sets Flex Databases apart

Easy implementation

We can deliver a fully functional system in the timeframe from 3 to 10 weeks, depending on the сlient involvement and requirements.

Complete data safety

We have a robust backup & disaster recovery and customer data protection strategy, including distributed data storages around the world.

Full compliance

Flex Databases is compliant with all major international and local regulations such as: ICH GCP E6 R2, FDA 21 CFR Part 11, GDPR, etc.

Flexible solution

Easily configure every part of our proprietary platform. The system is fully managed by end users. No installation required.

What they say about us

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.
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.

More about LMS & QMS

Digitalizing Quality Management System
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.

Learn more
Digitalizing Quality Management System-2
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.

Learn more
Webinar recording: Digitalizing Quality Management System
Webinar recording: Digitalizing Quality Management System: how and why?

In early April 2023 we’ve hosted a webinar about why and how you can digitalize your Quality Management System with our brilliant QA Director Anna Petrovskaya as a host.

Learn more
Configurable QMS to stay on top of your quality processes
Configurable QMS to stay on top of your quality processes

In our most recent update, we’ve made every process within QMS fully configurable. You get the LEGO blocks of different action items, a scheme being our default process workflow, and you can build it HOWEVER you want.

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.