We are pleased to announce that UNICORN™ Control System, version 4.0, fully confoms to 21 CFR Part 11 guidelines.

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

With the increased use and complexity of automated systems in biopharmaceutical manufacturing, the integrity of data has come into focus. The FDA has begun enforcing 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

In May 2001, an audit of UNICORN control system software version 4.0 was conducted by Dr. Sandy Weinberg, an independent consultant with more than twenty years’ experience of inspections and audits of biopharmaceutical systems. Dr. Weinberg concluded that UNICORN version 4.0 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 successful audit confirms that UNICORN version 4.0 is suitable for use in a GMP-environment. 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 are available upon request from your nearest sales office.

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