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Pharmaceutical labs need software solutions that will support Best Practices in the lab environment in every way while helping you work more efficiently.
SOTHIS optimizes all central lab processes, satisfying any international
GLP standard in terms of development and functionalities.
See for yourself!
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SOTHIS (Login screen)
Lab Master Data
- Article: Version management, rights-dependent release
- Test specifications: OOS and OOT limits, test period, test costs and analysis price can be specified for each article-specific test characteristic
- Test scope can be specified for each article (test object), depending on the type and time of the test.
Specification of test characteristics
Lab Processing
- Automatic generation of test orders for incoming samples and sample distribution to predefined warehouses
- Preliminary generation of test orders for stability tests
- Rights-dependent processing of test steps
- Configuration of auto-repeat for test steps whenever an OOS result shows altered tolerances
- Rights-dependent release of test results.
Computer-aided processing of test orders
Maintenance and Calibration of Test Equipment
- Rights-dependent management of test equipment and other resources
- Explicit release of a given resource prior to its use as test equipment
- Definition of any number of maintenance characteristics per maintenance type for a given resource
- Definition of standard costs, standard duration, tolerance limits, and precision units maintenance characteristics
- Definition of any number of maintenance plans for each resource
- Computer-aided processing of maintenance orders.
Materials Handling and Inventory Management
- Differentiated warehouse and storage location management
- Rights-dependent release of storage locations
- Configure any number of storage conditions
- Information on warehouse inventory and warehouse stock movements
- Consistent tracking of test batches
- Use of bar code scanners.
Differentiated warehouse and storage location management
Purchasing/Sales
- Processing and tracking of all commercial processes
- Simple billing, directly out of the test order
- Resubmission function
- Interfaces to diverse financial accounting programs (FibuNet, SAP R/3 FI/CO, Navision, DATEV, among others).
Simple test order billing
Reports/ Printouts
- Creating and customizing of reports (e. g. commercial documents, certificates of analysis, test instructions, etc.) with the easy-to-use MS report generator
- Printing, faxing and mailing of any report directly out of SOTHIS.
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Open-layout reports
Extension Options
- DMS: Automatic archiving of SOTHIS reports in PharAO, the DMS solution by GTI
- MIS: determining the key figures for the financial and quality controlling with Cognos Powerplay
- Project and sample planning: allocation of resources, including conflict visualization and resolution with integrated planning tools (e. g. MS Project, simcron).
Services
Validation Capability
As far as the development (qualified system according to EU/GMP standards) and functionalities (e.g., audit trail, electronic signature, batch tracking, and release management) go, our software meets the requirements of Annex 11 of the EU DMP Guideline, reflecting the guidelines of the APV, the FDA (21 CFR Part 11), as well as the latest GAMP Guide for the validation of automated pharmaceutical systems).
Configurable electronic signature for selected features
Technical Data/System Requirements
System Architecture Minimum Requirements:
- Client/server architecture for networked PC systems.
- Server operating system:
Windows 2000 Server or Windows 2003 Server - Work stations:
Windows 2000 Professional or Windows XP Professional - Server Database:
Microsoft SQL Server 2000
Hardware Minimum Requirements:
- Server:
State-of-the-art server machine with at least 2 processors and a memory of at least 1 GB. - Work stations:
State-of-the-art PCs, each with a minimum of 256 MB memory or higher.
SOTHIS System Requirements
