LIMS for Pharma and Process Industrie

• GxP, 21 CFR Part 11 konform
• scalable from 5 to > 500 Users
  Windows, Linux or Unix
  from Client Server to Web
• completely configurable Workflow, Masks, Languages, Reports, ...
• Open interfaces XML, SQL, IP, OPC to i.e. PLM, MES, PLS, CDS, instruments
• Options, stability evaluations, Managing Analytical Equipment, Environmental Protection Projects, Recipe optimization

SAP^TM PLM / QM^®
Middleware

• Unidirectional interface to connect simple laboratory devices
• Bidirectional interface to connect complex measuring instruments or control and calculation software
• Functions for calculations and conversions, e.g. calculation against references and blank readings
• Upgrades of functionality depending on attached devices and plug-ins for connections
• Statistics
• Automatic generation of inspection certificates, raw data sheets, labels and more
• Storage of raw data

Method Validation

• ICH, DIN, USP, 21 CFR Part 11 conform
• Assistance from planning to reporting
• scalable from single workplace to company solution
• Workflow with rights management
• Integration to CDS and LIMS
• Interfaces to LABS/Q, Varian Galaxie, AIA, XLS, RTF, DOC, PDF, BMP, JPG, WMF, XML

Synthesis / Recipe Otimization

• Projects with primal recipe / Reaction accommodation
  Interface MDL, F&E DB, Test planning DoE supports basic formulations including all conversions
• Editing of formulation
  Control recipe with connection of automates and PLS (OPC interface)
• Reporting/ Evaluation
  Document management system, SVG graphics, process visualization

Document Management
in Laboratory

• Management of documents, raw data, graphics etc.
• Version maintenance
• API interface for connecting external applications
• Conform to GxP, CFR 21 Part 11

Traceability Tool

• Integration of MS Office
• Conform to GAMP 4
• Easy to use
• Evaluation, Top down, Bottom up

Recipe Management

• Recipe development with n-step recipes, sub recipes
• LIMS functionality
• Recipe weighing for administration of formulations, refinement
• Conform to GxP, CFR 21 Part 11

Quality Control Charts

• Conform to 21 CFR Part 11
• Configurable out-of-spec situations
• Control charts for individual value, average, blank value, difference, retrieval rate, measurement range and standard deviation

Contract Laboratory LIMS

• Complete functionality for any contract laboratory
• Scalable: everything from five users to unlimited inter-divisional installations
• Low-budget starter edition can be enhanced with a wide spectrum of modules
• Easy integration of laboratory equipment, PDAs and Tablet PCs; barcode support
• Powerful reporting functions and integration with Microsoft Office and corporate applications
• Options: internet portals Request Point and Result Point

Services

• Creation of functional specifications
• Application development
• IQ/OQ Hard- and Software
• Training
• Client service, Software servicing, Hotline, 7 days / 24 hours support, WEB forum / Download
• User Meeting