The UNICORN control system is based on a dedicated controller and I/O interface with a computer-based graphical user interface. This graphical user interface is an integral part of the control system. Within the limits of the specified hardware UNICORN offers complete, simple programming for the user. The operation sequence is fully programmed by the end-user.

UNICORN control system functions include:
• Real-time flow scheme
• Trend curve data
• Display of all monitor values
• Method Logbook for full documentation
• Method start protocol
• Note books for pre-run, run, and post-run notes
• Method handling with full flexibility

UNICORN Control System fully conforms to 21 CFR Part 11 guidelines

UNICORN™ is the control system for ÄKTA™ , BioProcess™ chromatography systems, and OligoProcess™ peptide synthesis system. It is currently in use in many biopharmaceutical production processes approved by the FDA.

21 CFR Part 11
With the increased use and complexity of automated systems in biopharmaceutical manufacturing, the integrity of data has come into focus. The FDA has enforced its federal regulation for Electronic Signatures and Electronic Records - 21 CFR Part 11 - the rule to ensure security, accuracy and reliability of all electronic data used to meet GMP requirements.

Successful audit
UNICORN is regularly audited by an independent consultant with more than twenty years’ experience of inspections and audits of biopharmaceutical systems. Dr. Weinberg concluded that UNICORN conforms in all respects to all current and relevant FDA regulations including 21 CFR Part 11 for Electronic Records and Electronic Signatures, as well as with System Validation Standards and GAMP (US equivalent).

GAMP (Good Automated Manufacturing Practice) is a set of guidelines developed for suppliers and users of automated systems within the pharmaceutical manufacturing industry. These guidelines provide a framework for convergence with other existing standards and schemes, and will reduce the cost and time taken to achieve compliant systems.

Features
The new Electronic Signature System utilizes a dual password confirmatory and documenting locking scheme that is appropriate, compliant and applicable to the above mentioned guidelines.
The automatic audit trail system comprises complete documentation of the runs, such as raw data, method used, calibration, logbook etc., presented as a result file. There is also an Audit Trail Function for tracking data changes, user actions and fraud control on both a global and a system level. These functions are also appropriate, compliant and applicable to above mentioned guidelines.

Full report
The certificate and complete audit report on UNICORN are available upon request from your nearest sales office.

GLP (Good Laboratory Practice) Support
• User access levels
• Built-in start-up diagnostics (ÄKTAdesign only)
• Log books:
- run/method
- audit trail
• Protection of raw data
• Master batch records

For further information see Data File