Flex Databases Quality Management System – 1 system for 100% compliance
QMS module based on industry standards, latest trends, AND personal experience.
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.
Quality Management 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
Inbox
Create task
CAPA Management
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
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
- Documents generation and sign-off
- Actions implementation evidence
- Various KPIs tracked, performance measured on company level and per project
QMS: Audit management
- Audits 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
Our products
CTMS (Clinical Trial Management System)
Monitoring, subjects & sites management
eTMF (electronic Trial Master File)
Complete 24/7 visibility into all your trial documentation.
Project Management & Budgeting
A single Command & Control center of your tasks.
Pharmacovigilance
Your comprehensive drug safety database.
Flex EDC
Fast data capture and review.
Have we picked your interest?
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.