LabDesk CFR software
LabDesk CFR – Software compliant with CFR 21 Part 11
Modern laboratory data management compliant with FDA requirements
LabDesk CFR is an application developed by POL-EKO to facilitate the import, export, and secure management of data recorded by devices equipped with SMART PRO controllers. The software enables report and chart generation, supporting safe, traceable, and auditable laboratory operations – fully compliant with CFR 21 Part 11 requirements.
Who is LabDesk CFR for?
LabDesk CFR was created for laboratories, pharmaceutical and biotechnology companies, research units, and quality control departments operating under strict procedures regarding electronic records and electronic signatures.
The system complies with U.S. FDA (21 CFR Part 11) and European EU Annex 11 requirements, making it an ideal solution for laboratories operating globally.
Key features of LabDesk CFR
Data security and integrity
- Electronic signatures and user identification – each user has a unique account with defined roles and permissions.
- Secure access and password control – strong password enforcement, account lockout after failed login attempts, and multi-level authentication.
- Encrypted communication (SSL/TLS) – ensures complete data transmission security.
- Audit trail – automatically records all changes, logins, and user activities.
- Data integrity – stored data remains unchanged and protected from unauthorized modification in compliance with FDA requirements.
- Digital signatures – guarantee full traceability and authenticity of documents.
Document and data management
LabDesk CFR allows you to:
- import and export data from SMART PRO devices,
- generate reports and analyses in .pdf, .xlsx, or .csv formats,
- maintain full version control and data archiving in accordance with GMP/GDP procedures.
Why choose LabDesk CFR
- Supports up to 100 POL-EKO thermostatic devices equipped with SMART PRO controllers within a single laboratory.
- Web-based application – accessible via browser without the need for installation on each computer.
- Flexible user access – up to 10 user accounts per license, with operation in a secure internal LAN network.
- External electronic signature certificates – supports signatures issued by trusted certification providers.
Packages and licenses
| Product | Description |
|---|---|
| LabDesk CFR – CFR 21 Part 11 compliant software (SMART PRO only) | License for one PC including a USB dongle. Access for up to 10 users. Can connect up to 100 POL-EKO SMART PRO devices (after activation of the “LabDesk CFR – unit access” option). Includes digital signature and audit trail functions. |
| LabDesk CFR – unit access | Modification enabling a POL-EKO device to connect to LabDesk CFR (1 device = 1 modification). |
Documentation and validation
LabDesk CFR is supplied with a complete set of technical and validation documentation:
- Setup Manual – web server installation,
- Administrator Manual – system configuration and management,
- User Manual – user guide,
- IQ/OQ protocols – installation and operational qualification procedures.
Benefits for laboratories
- Compliance with FDA 21 CFR Part 11 and EU Annex 11,
- Improved internal and external audits,
- Reduction of human error risk,
- Easy access to data and reports in a secure environment,
- Increased laboratory credibility with clients and regulators.
