b + b software modules

the modular solution for serialization and aggregation of pharmaceutical products

b+b trace > Software > Pharmaceuticals

Software for serialization in pharmaceuticals 

Extensive modules and features are available for the implementation of (EU)FMD requirements at Level 3 level:

MODULES:

  • User and rights management

  • Audit Trail (in all modules)

  • Customer / target market management

  • article management

  • Work order management/process order management

  • serial number management

  • line management

  • interface management

  • label layout management

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FEATURES:

  • Create / edit / import workorder / process orders

  • Generate / import / report and decommission serial numbers

  • Entering/Decommissioning Serial Numbers in Goods Receipt 

  • Aggregate / de-aggregate serial numbers

  • Aggregation of own and external serial numbers (n-level)

  • Rework function for own / known serial numbers

  • Rework function for own / known aggregation levels

  • Reporting to n markets/customers/databases

  • Parameterization and communication of connected line managers (Level 2)

  • Overview of Workorders/Process Orders Assigned to a Line

  • 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:

  • User and rights management

  • Administration of database data
    (automatic backups, data cleansing, import/export)

  • Audit Trail (analog CFR 21 Part 11)

  • Customer / target market management

  • Article and print layout management

  • Work order management/process order management

  • serial number management

  • line management

  • 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.

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