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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