Further Services

Consulting for LIMS evaluation and implementation

The goal of many companies is to achieve a homogenous IT environment in which different systems optimally match the tasks of their area of application and are functionally connected to each other.  The communication between the systems usually takes place through integrated interfaces, so that unnecessary data maintenance can be avoided. Isolated applications can be solved with blomesystem®. The required time for training is substantially reduced as the basic principle of the individual programmes only has to be learned once. 

Our offer:

  • 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 process concept,
  • Assistance during the creation of a actual state analysis through extensive experiences in similar projects, questioning structures, scope conditions, special procedures as well as the size of the projects;
  • 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 the system "going live";
  • Definition of application expansions such as individual evaluations, necessary device connections or communication interfaces,
  • Definition of predetermined breaking points in further progress of the project to avoid possible misallocation

Customer service of AJ Blomesystem GmbH

 

The implementation of the management system takes place by the development of a project plan with consecutive project steps. It 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
    • Recipe 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 early phase after operation startup

The progress of the project can be retraced and controlled at any time through the project plan. For the complete implementation of such a software system, further services such as trainings or hotline service can be included.

Your software is to be validated?

Our services in the field of computer validation (CSV) encompasses all phases of the software life cycle up to the decommissioning and offers efficient and practice oriented solutions for your requirements. 
We support you 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
  • Sample SOPs for system administration
  • Examples and check lists for individual risk evaluations
  • Documents for the installation qualification (IQ)
  • Test plans and check lists for the operational qualification (OQ)
  • Documentation and standard documents for change control management and revalidation processes
  • Check lists for audit preparations in the scope of existing QM systems

The aim of a consultancy by our certified experts is to determine the required validation depth to keep the effort as appropriate 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). Our procedures are based on a risk analysis (risk based approach), as reccommanded by FDA and GAMP 4. Our documentation conforms with GMP and corresponds with the requirements of the current regulations.