Our LIMS products

LABbase^® is a Laboratory Information Management System, based on blomesystem^®, which has all the functionalities required for the daily tasks in a professional laboratory.  

With this system AJ Blomesystem GmBH (AJB) presents a genuine Standard System. In this context "Standard" means that the modular applications in LABbase^® are preconfigured and can be customised to the special requirements of the customer just like a suit which should fit to perfection.  In addition, we provide LABbase^® Designer which is an integrated tool that can be used by trained staff to further customise the system — and all this without jeopardising the updateability of the system.

The basic configuration of LABbase^® includes:

• Basic data - general  function and data handling (e.g. user and addresses administration)
• Core LIMS - all information about sample processing of master data 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 measurement instruments and accessories
• Sample evaluations and release
• Result generation
• Reports administration/ creation of test reports based on templates

A LIMS for everybody and everything
LABbase is capable of  handling the entire workflow of a modern laboratory. The modular design  and the integrated customisation tools allow our licensed contractors to address the requirements of our customers individually, modify the analyses  — if required — and adjust the reporting to the ever changing requirements. Modular extensions are available for laboratories which work production or batch orientated.

Validation and QA
LABbase is a completely qualified product. All 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.  AJB has been working under a QM system for several years and is certainly DIN EN ISO 9001 certified. Customer audits confirm the outstanding quality guaranteed by this system.

Multi Language Support
The user interface and master data can be easily translated into any desired language.  The applications are currently available in English, French and German.  A dedicated  module is available to maintain the translation of mask and block titles as well as field labels etc. Reports are independent of the user interface language.

Multi Location Support
Your company has several business locations? No problem! 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  the individual user groups.  With the combination of multi language support and interfaces to modern communication technology,  LABbase opens up a new dimension for multi location laboratory tasks. Database maintenance and security tasks are centralised in one location.

Service
The decision for LABbase is a decision for exceptional service. We offer a customer closeness that is second to none in the industry. 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 a comprehensive training programme.

^{Add on modules to LABbase® are integrated at once or in combination.
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 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

• Webfarm
  LABbase^® web can be distributed depending upon user load on different servers. This includes vertical and horizontal scaling. An extention of hardware can be the upgrade of a server or the extention of server farm by new servers.
  
  
• Clustable
  LABbase^® web supports the use of cluster data bases.
  
  
• Multi-Tier architecture
  Modern multi layer application which separates database, application and client.
  
  
• Web-based
  Connect clients over the WWW.
  
  
• SSL coding for safe communication
  Data encryption by SSL over TCP/IP and HTTP.
  
  
• Click-Once-Deployment
  Simple installation on a client computer which fits the requirements for the system.
  The client can be downloaded from company-owned intranet without assistance by an external IT-worker locally.
  
• Native Windowsapplication
  Windows look and feel
  Comfortable GUI with extensive possibilities of the data aggregate and assortment
  Windows Vista ready
  Support of function keys (like e. g. 'Strg + S' for memory or 'Strg + L' for load ...)
  The application is as far as possible controllable over the keyboard.
  Kontextsensitive menu.
  Support of different charts.
  
  
• Crystal Reports as reporting tool
  Create your reports with Crystal Reports, with is a common reporting tool.
  
  
• Integrated document administration
  Report files can be exported as PDF files and persisted to database.
  
  
• Integrated formula interpreter
  Calculation formulas can be defined by user defined code.
  
  
• Configurable Workflow
  By use of condition automat (state machines) release mechanisms can be configured for both, master and transaction data.
  
  
• User-optimized processes
  Use of work lists and automatics for the fast execution of individual tasks in the system.
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Target Group:
Our standard system LABcua based on our LIMS LABbase^® was developed specifically for food and drug authorities and analysis agencies.  The requirements of private enterprise laboratories for invoicing is also supported.  

Overview:

• Comfortable and extensive automatic report creation for BVL and integral optical-fiberAE metrology.
• 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 time period of the catalogue data is used for control, the time period can be entered or automatically transferred. 
• The continual editing of the samples, even after new catalogue versions are loaded, is secured. 
• The selection of the correct coding from the valid catalogue version on the date of sample input is ensured. 
• If the master data are correctly maintained, then the creation of report data for BVL or ILM (integral optical-fiberAE metrology) results by the press of a button without further time and effort. 
• Further statistics such as the "national" and "EG statistics" are integrated.  Delivery of the required data also results by the press of a button.
  

Details:

The ADV catalogues can, for example, be retrieved from the internet as sst files.  By pressing a button they are loaded into the LIMS.  In the next step, you can can specify until when the previous catalogue version should be valid. 

Several ADV catalogues, such as ZEBS, matrix add-on, reason for sampling or reason for complaint can be selected directly during sample processing.  These can be entered either by selecting from a list or by entering the code directly.  The system ensures that only those catalogue data valid for the entered date of the sample are displayed and that also the manual input only allows the valid code. 
Some inputs such as "country of origin" or "council ID" are, for example, transferred to the sample from the addresses administration during selection of the manufacturer. 

Also in the case of results, various catalogue data such as material detection certificates or sample preparations can be entered directly or filled out in part by default. 

The other required codes are added to the samples or results by connecting the master data such as methods, parameters or units with the ADV catalogues on a time controlled basis.  The system thereby adjusts the data in the background so that sample and result records are automaticall created which contain all the ADV codes. 

These can be visually checked and edited in an additional mask, if required, before creating the report files.
However, it is also important here that your master data, independent of the ADV catalogue versions, remain valid but still remain connected with these.  LABcua also supports you here when you have entered changes:

• Automatic recognition which actually used ADV catalogue data were changed in the new catalogue version,
• Support during editing of the master data

On top of this, the system offers practically 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 of 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 generationl; prices can be retrieved from a "scale or charges and fees". 

Additionally:

• Simple creation of certificates by direct printing of reports in the "department mask" or by transferring the LIMS data into a WORD template.
• Automatic status administration, but also comfortable "resetting" of samples. 

LABcua, the new standard system based on LABbase^® therefore contains forward looking features such as:

• Special functions for control departments and investigation agencies,
• But at the same time also the full function suite for private enterprise laboratories,
• A standard system, but still open to versatile configurations and customizable for individual requirements.

LABpharma^® covers all processes in the pharmaceutical development and control laboratories.

Galenics

• Acquisition of all incoming goods
  
• Administration of raw materials amd ingredentients
  
• Creation and processing of recipes using any desired number of production steps unsing materials captured in the system
  
• Creation and administration of manufactureing specification from the recipes

Analysis

• Stability rows or stability pattern tests
  
• During registration of incoming goods, LABpharma^® can automatically create batches and testing jobs specific to material and defined algorithms for the entire stability period. This functionality reduces the processing effort and considerablysimplifies the removal of stock.
• Sample storage
  
• Material and item administration
  
• Testing specifications with specification limits
  
• Testing plans
  
• Testing jobs with result acquisition
  
• Report module to create sertificates and document templates.

Documents

• Release and handling of quality relevant documents, such as certificates and SOPs, has also been integrated into LABpharma^®.

With help of electronic signatures, document receival as well as document confirmation can followed simply and securely. Distribution can take placesimply and in a time saving manner through defined distribution groups.

Administration

• Master data administration, chemicals, packaging
  
• Administration of addresses and contact information of your customers, manufactors and suppliers
  
• Comfortable 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, in terms of its development (qualified system according to EU/GMP standards) and its functionalities (e.g. audit trail, electronic signatures and release administration), 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 GAMP4 guide for validation of automised system and has already been successfully implemented in the regulatory environment. These standards are also of value in the non regulatory environment, because they assure useful security and quality aspects in the laboratory.

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 the individual risk disclosure
  
• Examples SOPs for system administration
  

These materials allow a scure and especially appropriate validation (risk based approach) on site at your location. As an optional, our certified validation experts personally support you in this task.

Target group:
All institutions which, as part of their work, have to collect, process and research expansive information about investigative procedures and cout evidence. This system is especially suited to criminal agencies which deal with a large amount of such information. Fast research ability of this information and database supported administration is importent for the corresponding authority.

FIVAS is an application created with blomesystem® for the administration of procedures / cases and all corresponding information. FIVAS is targeted towerdsthe administration of criminal technical information. Comprehensive acquisition of all necessary information for a procedure is possible. Starting with procedure creation, protocol storage, acquisition of all court evidence, creation of the required specified testing jobs as well as the testing job related generation of various reports and documents.

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 verificatio 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.

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 of these types of control charts.

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

Four different modes ar offered for determining control limits:

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

• Mode 2 is especially applicable to repeat control charts (Middle line not as repeat but as 100 %)
  
• Mode 4 has influenceon the determination of the outer control situations. It simplifies the recognition of a mean drift. This mode should take into consideration the known case when during creation of the control chart, the standard deviation of the individual chart is becoming smaller and smaller due to the constantly improving perfection of the laboratory staff. As a resualt, the control area also becomes narrower. If outliers appear in such a case, thay will always lead to violation of the warning or control limits. In chatrs from an earlier period, thay would not have shown up.

The evaluation of the control values results according 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);
• Mean t-test between the mean of two conscutive periods;
• Variance homogeneity (f test) between the variance of two consecutive periods.

Addintional features  for the AJB-AQC module:

• Subsequent expansion of a pre-period (especially useful in the organic chemistry);
• Multiple language support of the interface as also offered in other AJB products (German, English, French);
  
• Predictive consideration of the new LAWA guidelines (in discussion since January 2004); when it comes into effect, the new policy becomes effective through minor configuration of the system information.

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

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

Various actions can be set or implemented via the administration menu:

• Creation and deletion of database users;
  
• Password management and administration of system settings;
  
• Configuration of the audit trail (documentation of chenged data and settings during the running of control charts).

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.

If master data are missing or a file with control values is loaded first, then the automatic master file comprarison must be run (administration menu).

The transferred data can be loaded into the corresponding control chart by the press of a button.

Summary:
The AJB-AQC module offers you an elegant opportunity to maintain control charts for your measurement instruments integrated in your existing blomesystem® LIMS or as a stand alone solution parallel to your analytical task.