b + b software modules
the modular solution for serialization and aggregation of pharmaceutical products
Software for serialization in pharmaceuticals
Extensive modules and features are available for the implementation of (EU)FMD requirements at Level 3 level:
MODULES:
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User and rights management
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Audit Trail (in all modules)
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Customer / target market management
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article management
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Work order management/process order management
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serial number management
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line management
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interface management
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label layout management
FEATURES:
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Create / edit / import workorder / process orders
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Generate / import / report and decommission serial numbers
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Entering/Decommissioning Serial Numbers in Goods Receipt
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Aggregate / de-aggregate serial numbers
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Aggregation of own and external serial numbers (n-level)
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Rework function for own / known serial numbers
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Rework function for own / known aggregation levels
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Reporting to n markets/customers/databases
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Parameterization and communication of connected line managers (Level 2)
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Overview of Workorders/Process Orders Assigned to a Line
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Communication to Level 4 and Level 5 systems
We recommend the following modules to realize your EU-FMD-Compliance:
Module:
Features:
b+b Siteserver
Utility program for interface and data automation, license handling
b+b Sitemanager
Administration of users/user groups - detailed assignment of rights
Managing Report Authorizations
Work order management (new/edit/archive/prioritize) - Assignment to production line
AuditTrail - Research
Customer|Market|Product Master Data|Serial Number Logic|GLN Number Management
Managing the Aggregation Hierarchy(s)
label layout management
Line recipe management per article (recipe selection|control weights|tolerances)
Serial Number Management| Aggregation Level Management|Reworking|Sampling
Message status display
Decommissioning of reported products (sampling, theft, recall, etc.)
b+b ERP Link
Interface to your ERP system
b+b Repository Link
Interface to Level 5 (national repository, international repository)
b+b Linemanager
Level 2 Software component for parameterization and control of line components
b+b Linemanager Aggregation
Level 2 Software component for parameterization and control of line components
with aggregation (ePedigree = electronic family tree)
b+b Storage List Module
Module for the recording of checked codes for the creation of warehouse lists/pallet accompanying documents
b+b Packing List Module
Module for recording codes (also aggregation codes) in outgoing goods, including assignment of shipping numbers, packing list numbers, etc.
LabelsPlatform 4 Premium
Program for layout creation and communication with printing systems - LINK
We recommend these additional modules as RE- or PARALLELIMPORTEUR for the realization of your EU-FMD-Compliance.
b+b WorkOrderLabelModul (WOLM)
Label printing and production order creation with monitoring of printing progress with print preview
b+b Entrance Module
Module for recording codes in incoming goods, including assignment of incoming goods numbers/container numbers or optional customer numbers.
b+b Repack Module
Module for assigning raw materials to production orders and prompt decommissioning in the reporting system
b+b Code Check Module
Module for activating/deactivating serial numbers by hand scanner before reporting to the repository - the solution if no automatic camera control is possible
We recommend these additional modules for the implementation of your EU-FMD-Compliance as WHOLESALER:
b+b Entrance Module
Module for recording codes in incoming goods, including assignment of incoming goods numbers/container numbers or optional customer numbers.
b+b Siteserver / b+b Sitemanager:
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User and rights management
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Administration of database data
(automatic backups, data cleansing, import/export) -
Audit Trail (analog CFR 21 Part 11)
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Customer / target market management
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Article and print layout management
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Work order management/process order management
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serial number management
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line management
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Interface management to all repository systems
The b+b SiteServer is the central database and service application and represents the control center for the complete software modules.
The customer is provided with a Windows VM and an MS SQL Server database. The b+b SiteServer can be operated either as an ON-PREMISE or CLOUD installation.
b+b provides the SQL Server database with the required table structures. The customer receives read access to the table data.
