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Quality and Learning Management

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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Manage SOPs, audits, incidents, and CAPA with

Flex Databases Quality Management System

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.

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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.

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Organize simple onboarding & qualification check-up with

Flex Databases LMS

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.

Keep all your courses and materials in LMS library.

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Ensure staff’s inspection readiness with

Flex Databases LMS

Update QA documents with just few clicks, followed by automated training for employees.

Automatically maintain matrixes for trainings and SOPs.

Use compliant e-signature to confirm that the training was passed, or SOP reviewed.

See full list of features

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 client 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

Features

QMS: CAPA Management

Initiating CAPA review, planning, and resolution

Assigning responsible team members to tasks and process steps

Tracking all the responses and progress of CAPA

CAPA observation period scheduling and tracking

CAPA effectiveness tracking 
and evaluation

Documents generation and sign-off

Actions implementation evidence

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: Training management

Project and line manager areas

Electronic employee training records

Training matrix management

Automatic and manual training assignment for any group: e.g., department, position, project, country

Multiple trainings assignment to one employee in a batch

Automatic alerts to employees and 
their supervisors on assignments & overdue trainings

Completion confirmation with eSignature

LMS: Training types

Self-trainings, training sessions and courses

Project- and sponsor-specific trainings

Quizzes with different question types

Possibility to use courses in SCORM format

Recurrent trainings

LMS: Document management

Corporate SOP library management

Optional training library

Possibility to attach images, PDF files, videos, links to external resources, or other documents as training materials

Configurable access to view and download PDF files and images

LMS: Reporting

Reports and statistics on training results

Ad-hoc reporting tool for cross-project and cross-module reporting (graphs, widgets)

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