LabDesk CFR
Compliant lab data,
fully under control.
Modern laboratory data management for devices with SMART PRO controllers – secure, traceable and audit-ready in full compliance with FDA requirements.
Overview
Software compliant with CFR 21 Part 11
LabDesk CFR facilitates the import, export and secure management of data from devices equipped with SMART PRO controllers. It generates reports and charts that support safe, traceable and auditable laboratory operations – fully compliant with CFR 21 Part 11.
Every action is recorded, every record is protected, and every signature is verifiable – giving your laboratory a single, dependable source of truth.
Built for regulated environments
Who is it for
Made for laboratories that answer to regulators
LabDesk CFR is designed for organizations where data integrity is non-negotiable – meeting both U.S. FDA (21 CFR Part 11) and European (EU Annex 11) requirements.
Laboratories
Analytical, testing and R&D labs that require verifiable records.
Pharma & biotech
Companies operating under GMP/GDP and FDA oversight.
Research units
Institutes and universities managing sensitive study data.
Quality control
QC/QA departments enforcing strict compliance procedures.
Key features
Everything you need to stay compliant
Two pillars keep your operation audit-ready – uncompromising data security and disciplined document management.
Electronic signatures
User identification with unique accounts and clearly defined roles for every operator.
Secure access
Strong password enforcement combined with multi-level authentication.
Encrypted communication
All data transfer is protected end-to-end with SSL/TLS encryption.
Automated audit trail
Every change and activity is recorded automatically – nothing slips through.
Data integrity protection
Built-in safeguards prevent unauthorized modification of records.
Digital signatures
Guarantee full traceability of who did what, and when.
Import / export
Move data seamlessly to and from SMART PRO devices without manual re-keying.
Report generation
Produce professional reports in PDF, XLSX and CSV formats on demand.
Version control & archiving
Retain and archive data in line with GMP/GDP procedures.
Charts & visualization
Turn recorded measurements into clear, shareable charts instantly.
Traceable history
A complete, time-stamped record supports every export and report.
Structured records
Consistent, organized data ready for internal and external audits.
See it in action
A clear, browser-based workspace
Manage devices, review data and generate compliant reports from one intuitive interface – accessible from any browser on your network.
Why LabDesk CFR
Scale that fits your whole facility
A single, browser-based platform that grows with your laboratory – no installation, no per-seat headaches.
Packages & licenses
Choose the right configuration
A straightforward licensing model – one software license for your facility, plus a per-device modification for every unit you connect.
LabDesk CFR
- Single-PC license with USB dongle
- Up to 10 user accounts
- Connects up to 100 POL-EKO SMART PRO devices
- Includes digital signature and audit trail
LabDesk CFR – unit access
- Enables a device to connect to LabDesk CFR
- One modification per device (1 device = 1 modification)
- Ordered per unit alongside the software license
- Configured for full CFR compliance
Important: CFR-configured units are compatible exclusively with LabDesk CFR software and cannot connect to standard LabDesk or LabDesk Cloud versions. This configuration is performed during manufacturing only.
Documentation & validation
Everything you need to qualify the system
LabDesk CFR ships with a complete documentation set that supports installation, configuration, day-to-day use and formal qualification.
Step-by-step guidance for installing the web server and getting LabDesk CFR running on your network.
Full system configuration – user accounts, roles, security policies and device connections.
A practical guide for daily operators covering data import/export, reporting and signatures.
Installation and Operational Qualification procedures to formally validate the system for regulated use.
Benefits for laboratories
Compliance that pays off every day
Beyond ticking regulatory boxes, LabDesk CFR strengthens your operation from audit to reputation.
Ready to make your lab audit-proof?
Talk to our specialists about LabDesk CFR licensing, device modifications and validation documentation for your facility.