Consulting for LIMS evaluation and implementation

The goal of many companies is to achieve a homogenous IT environment in which different systems are optimally tuned to the tasks of their area of application and are also functionally connected to each other.  The communication between the systems usually takes place through integrated interfaces, so that unnecessary data maintenance can be avoided.  Different island solutions can be solved with blomesystem^®.  This results in a unification of the systems. 

The time required for training is substantially reduced as the basic principle of the individual programmes only needs to be learned once.  A further positive effect is the increase in acceptance of the systems.   We can support you during the search for the right basis for your management system for production and quality contol through detailed consultation regarding:

• Analysis of your workflow and positioning of the planned system,
• Estimation of the approximate time and cost frame for such a system,
• Support during the development of the procedure concent,
• Help during the creation of the is analysis through extensive experiences in similar projects, knowledge of structure, scope conditions, special procedures, sizing of project;
• Provision of know how for the preparation of specifications with definition of the functional and technical requirements and project guidelines,
• Support during system installation by project management for the installation through to the system "going live";
• Definition of application expansions such as individual evaluations, necessary instrument connections or communication interfaces,
• Definition breaking points in further advances to the project to avoid possible mismanagement. 
  

Customer service of AJ Blomesystem GmbH

Using blomesystem^® we create software products as management tools for production and quality control. It makes homogenization of your IT environment possible by allowing you to customise various blomesystem^® standard modules to your requirements with blomesystem^®. All modules and projects are constructed using the same principles. This results in compatible building blocks which can be combined into complex function units. Foreign systems are integrated with blomesystem^® interfaces and together produce a homogenous IT network.Individual blomesystem^® interfaces are certified, such as e.g. QDI interface to SAP R/3.

The implementation of the management system results through the development of a project plan with project steps which each build on the previous step. This contains:

• The development of a detailed concept for your requirements
• Possible realization through blomesystem^® standard modules such as e.g.:
  
  
  • Goods received control
  • Supplier evaluation
  • Sample planning and preparation
  • Administration of test sizes (parameters, methods)
  • Administration of test profiles (standard analysis plans)
  • Administration of limit and reference values,
  • Price administration,- Instrument administration with corresponding control charts
  • Calibration of test methods, calculation of procedure data and running of control charts
  • Chemicals administration
  • Test plan administration
  • Laboratory book/ Labjournal administration
  • Packaging control
  • Formulations administration

• Exact definition of necessary expansions to the application
• Installation of the standard modules and expansion of the implemented applications
• Certification of the system and production startup in your environment
• Support in the beginning phase after operation startup

The project advance can be retratced and controlled at any time through the project plan. For the complete implementation of such a software system, further services such as training, hotline advive if required, etc. are of course included.

Your software is to be validated? We also provide services for this task.

Our services in the field of computer validation (CSV) encompasses all phases of the software life cycle up to decommissioning and offers you efficient and practice oriented solutions for your requirements. 
We support yout with all tasks relating to computer validation (CSV):

• Consultation about valid regulations and validation requirements for your specific project
• Creation and Documentation of validation master plans
• Example SOPs for system administration
• Examples and check lists for the individual risk evaluations
• Documents for the installation qualification (IQ)
• Test plans and check lists for the operational qualification (OQ)
• Documentation and standard documents for changes management and revalidation processes
• Check lists for audit preparations in the scope of existing QM systems

The goal of the consultation by our certified experts is to determine the required validation depth to keep the effort as low as needed. We work according to the standard GAMP 4 guidelines and especially take into consideration the Code of Federal Regulations, CFR 21, Part 11 - electronic records & electronic signatures (ER / ES). We base our procedure on a risk analysis (risk based approach), as reccommanded by FDA and GAMP 4. Our documentation conforms to GMP and corresponds with the requirements of the current regulations.