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.

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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

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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

Product Sheet PDF

Dashboard

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

Schedule

SCORM

User Area

Features

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.

Jul 4, 2024

Strategies for Effective Site Selection and Management in Clinical Trials

Effective site selection and management are critical components of successful clinical trials. Choosing the right locations and overseeing their operations can significantly impact the trial’s timeline, budget, and ultimately, its success in delivering reliable data. This article explores essential strategies for optimizing site selection and management, highlighting key considerations, practical tips, and the role of […]

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Jun 11, 2024

Quality Over Quantity: Optimizing Clinical Research with an Effective QMS Strategy Databases

Quality management in clinical research is crucial to ensure the integrity, reliability, and validity of the data collected. This process encompasses all activities that ensure the study is conducted in compliance with regulatory requirements, guidelines, and best practices. Adding QMS strategy databases in your organization can help your processes by miles.

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Nov 28, 2023

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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Digitalizing Quality Management System-2

Oct 30, 2023

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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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.

LMS & QMS

Streamline all QMS processes in one system

Build up your dream system – your needs is the limit

Make training process easy and fun with Flex Databases LMS

Organize simple onboarding & qualification check-up