Complete software compliance to FDA 21 CFR Part 11 for the BioNova Celeno HPLC products as well as systems from Kontron and Bio-Tek Instruments
With the new Geminyx software, Spectro BioNova provides complete software compliance according to FDA 21 CFR Part 11 for the BioNova Celeno HPLC products.
Furthermore, Geminyx is compatible with the HPLC systems from Kontron and Bio-Tek Instruments, which ceased software-upgrading support in 2001.
For the approximately 2000 users of these systems across Europe, Geminyx offers the prospect of easy migration to a new, FDA compliant, software package.
The Geminyx software takes into account all aspects of software compliance according to FDA 21 CFR Part 11.
An Administrator Tool can be used to set user rights for actions such as reading, writing, and modification of individual documents as well as for complete analysis methods.
In order to simplify customising, the typical authorisation stages (author, review, authorisation of a method development or individual analysis) are stored as database masks.
Should the user introduce additional checks, these can be integrated easily.
Geminyx automatically writes all of the raw data files originating from the detection unit, as well as the files with interpreted results, into the database.
The software automatically assigns each file with the electronic signature of the operator (username, password, confirmation) and time stamps.
This makes it clear who processed which authorisation when and for which process.
The document output is realized by means of tamper-proof pdf files.
In addition, the software provides easy search routines and database filters.
This allows, for example, a laboratory director to review all of the analyses requiring sign-off at once.
Geminyx supports Oracle databases (Oracle Server Version 7, 8, and 9) and also Microsoft SQL Server (Version 7 and 2000).
Smaller applications in stand-alone operation can be linked to an Access database.
One essential aspect of workflow control in a laboratory is the handling of analyses that contain results lying outside of the expected limits, eg, due to contaminated samples.
With Geminyx these measurements can only be thrown out and marked as invalid when a substantiated declaration is given.
With this information, the identification of the causes for erroneous results in later monitoring is simplified.
To accelerate the customising process for Geminyx software and to ease the costs of meeting specific customer requirements, the software is available in a number of configurations for different applications, eg, in the areas of pharmaceutical, biotechnology, environmental analysis, and petrochemistry.
As Karin Dietze, Spectro BioNova division manager, emphasises, "approximately 80% of typical requirements for adapting HPLC evaluation software can be eliminated by application-specific pre-configurations." Simultaneously, this preliminary work accelerates the qualification process across all qualification phases.
Thus, for the design qualification, already validated qualification documents are available for standard applications.
In the area of Installation Qualification (IQ) Geminyx automatically monitors the installation during the setup and alerts the system administrator if any of the operating system files have changed. For other qualification phases, such as operation qualification (OQ) and performance qualification (PQ), Spectro BioNova supports the user, on request, with service packages.
