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Insights on what makes the most impact on the project.
Instant full picture in one interface. Sense of full control.
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.
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.
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.
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.
What sets Flex Databases apart
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
Flex Databases is compliant with all major international and local regulations such as ICH GCP E6 R2, FDA 21 CFR Part 11, GDPR, etc.
Easily configure every part of our proprietary platform. The system is fully managed by end-users. No installation required
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
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
Reports and statistics on training results
Ad-hoc reporting tool for cross-project and cross-module reporting (graphs, widgets)