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Analytik Jena Company

  • AJ Blomesystem GmbH
  • AJ Cybertron GmbH
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  • CyBio AG
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Our LIMS products

  • LABbase®
  • Add Ons
  • LABcua
  • LABpharma
  • FIVAS
  • Control Charts
  • readyLIMS®
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LABbase®

LABbase® is a Laboratory Information Management System based on blomesystem®, which comprises all functionalities required for the workflow in a professional laboratory.  

 

The basic configuration of LABbase® includes:

  • Basic data - general  function and data handling (e.g. user and address administration)
  • Core LIMS - all information about sample processing of master data up to order and sample data
  • Audit-Trail - configurable change history
  • Storage of binary objects - allocation of files to every record
  • Limit administration - interactive evaluation of results
  • Test methods - administration of test methods with test parameters and methods
  • Units - administration of measurement units and their conversions
  • Instrument management - administration and testing of instruments and accessories
  • Sample evaluations and release
  • Result generation
  • Report administration / creation of test reports based on templates

Validation and QA
AJ blomesystem GmbH is DIN EN ISO 9001 certified. All in LABbase® 800 integrated objects have been evaluated using risk analysis and were tested to exhaustion.  Any laboratories deciding on LABbase can therefore expect a greatly reduced effort required to validate the LIMS. 

Multi Language Support
The user interface and master data can be easily translated into other languages.  The applications are currently available in English, French and German. 

Multi Location Support
Your company has several business locations? With LABbase® you only need one central database - the same master files can be used by all users. Access rights to the data can be defined for individual user groups. 

Service
A tight network of certified service and sales partners guarantees that any customer can be reached by our LIMS specialists in a very short time.  In addition, we offer comprehensive training programmes.

 
 
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Add on Modules for LABbase®

Add on modules to LABbase® are integrated individually or in combination.
The following add on modules are available:

  • Accounts - accounts module, from quotation to invoice
  • Production - production module with article administration, receipt administration and production related samples
  • Control charts - control charts module for average, blank value, range and recovery control charts
  • SOP - administration location dependent administration of SOPs (Standard Operational Procedures) 
  • CRM - customer Relation Management as a module for customer administration and reminders module
  • General interface module - interface module for connecting various systems and instruments
  • CSP - Cyclical Sample Planning module for cyclic samples
  • Project administration - for administration of projects
  • Public Web Server - module as an option to retrieve sample information through the web for your customers
 
 
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Target Group:
LABcua, which is based on our standard system LIMS LABbase®, was specifically developed for food and drug authorities and analysis agencies. 

Overview:

  • Convenient and extensive automatic report creation for the BVL and ILM.
  • All required ADV (Working Committee of the Surveying Authorities of the States of the Federal Republic of Germany) catalogues are integrated and versioned.  
  • The validity period of the catalogue data can be entered or automatically transferred. 
  • If the master data are administrated correctly, the creation of report data for the BVL or ILM can be done by simply pressing a button. 
  • Further statistics such as the "national" and "EG statistics" are integrated.  Delivery of the required data also can be done by simply pressing a button.

Furthermore, the system offers all the functions of LABbase® such as:

  • Working with multiple locations <--> access control
  • Creation of sample series
  • Comfortable changing of the test suite, predominantly independent from the sample status
  • Sample dispatch - management
  • Raw data processing for test methods and sample preparation; contol samples -> laboratory book function
  • Working with text building blocks
  • Manual or automatic invoice generation

 

 

 
 
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LABpharma®

LABpharma

LABpharma covers all processes in pharmaceutical development and control laboratories.

Galenics

  • Acquisition of all incoming goods
  • Administration of raw materials and ingredients
  • Creation and processing of recipes using any desired number of production steps
  • Creation and administration of manufacturing specifications from the recipes

Analysis

  • Stability rows or stability pattern tests
  • Sample storage
  • Material and item administration
  • Test specifications with specification limits
  • Test plans
  • Testing with result acquisition
  • Report module to create certificates and document templates.

Administration

  • Master data administration, chemicals, packaging
  • Administration of addresses and contact information of your customers, manufactors and suppliers
  • Convenient definition of your workflows (e.g. release, status control)
  • Allocation of user rights for every system functionnality

Regulatory aspects and validation

The LABpharma system fulfils the requirements of Annex 11 of the EU GMP guidelines under consideration of the guidelines of the FDA (21 CFR Part 11) as well as the GAMP4 guide for the validation of automated system and has already been successfully implemented in the regulatory environment.

AJ Blomesystem GmbH offers the following optional extras for the product LABpharma:

  • Documents for installation qualification (IQ)
  • Test plans and check lists for operational qualification (OQ)
  • Templates for validation plans
  • Examples and check lists for individual risk disclosure
  • Examples SOPs for system administration
 
 
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FIVAS - Forensic Information Workflow and Court Evidence Management System

Target group:

FIVAS is an application created with blomesystem® for the administration of procedures / cases and all corresponding information. FIVAS is suitable for the administration of forensic information. Comprehensive acquisition of all necessary information for a procedure is possible.

FIVAS strengths:

  • Structured, case specific administration of all acquired data and persons as well as the storage of the original documents (investigation application, CT protocols etc.) in the database.
  • Encryption, anonymisation of the personal data.
  • Acquisition of all notes and information incidental to procedures as well as their system wide availability.
  • Department releated allocation of court evidence with gapless, person related verification of the court evidence procedure.
  • central court evidence administration with barcodes and labels.
  • Automatic creation of testing jobs corresponding to the requirements.
  • Generation of certificates, reports and other documents and storage in the database (access control).
  • Protocolisation of all court evidence and document issuances.
  • Administration of picture documents.
  • Integrated laboratory management system.
  • Consequent use of catalogues in the entire system.
  • Integration of varying collections and their research.
  • Control of processing status through given system automatics and their protocolisation.
  • Quality assurance and monitoring of all implemented work steps.
  • System monitoring through status administration including history.
  • Statistical analysis of all administered data.
  • Comprehensive, detailed research possibilities in the system.
  • Long term archiving of the data.
 
 
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Control Chart Module

Target group:

For all analytical laboratories that work with control charts for their measurement instruments. It is irrelevant whether you are dealing with mean values, blank values, range or repeat control charts. The AJB AQC module is applicable for all these types of control charts.

Overview:

The AJB AQC module is based on the AQS data sheet for recommendations of the working group of the federal states for water (LAWA) for quality assurance of water, sewage and mud investigation (AQS A-2 1991/1994).

Four different modes are offered for determining control limits:

  1. Average values and limits from previous periods;
  2. Limits from previous periods which are normalised to a given reference value;
  3. Self-defined limits and/or fixed limits and/or reference valuse from the standard substance;
  4. Giving a lower limit for the standard deviation and a difference between a reference value and the average value of the pre-period.

The evaluation of the control values is done according to the rules confirmed by LAWA:

  • Violation of the control limits;
  • n of m consecutive values violate the warning limit;
  • n ascending or descending values;
  • n values on one side of the middle line.

Between different control periods of the same control chart, implemented statistical test procedures can be used. Such statistical test procedures are:

  • Test for normal distribution (Shappiro/Wilk);
  • Average value t-test between the average value of two conscutive periods;
  • Variance homogeneity (f test) between the variance of two consecutive periods.

Stand alone application

The AJB-AQC module can also be operated stand alone application. An integration into a blomesystem® LIMS is not necessarily required. However, for stand alone operation, certain master data are required:

  • Testing instruments
  • Parameters
  • Methods
  • Units
  • Standard substances
  • Matrices

Data transfer from the measurement instrument:

In combination with the LABDDI module (simplified interface module for measurement instrument connection) by AJB, control values can be transfered directly from the measurement instrument. During transfer, various controls for the presence of the master data take place. The transferred data can be loaded into the corresponding control chart by simply pressing a button.

 

 

 
 

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