fmd_eufmd.jpg

serialization software

for pharmaceutical products

b+b trace > Software > Pharma

Software for serialization in the pharmaceutical industry 

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

modules

  • User and rights management

  • Audit Trail (in all modules)

  • Customer / target market management

  • item management

  • Work order management/process order management

  • Serial number management

  • line management

  • interface management

  • label layout management

SC_Information.png

features

  • Create / edit / import work orders / process orders

  • Generate / import / report and decommission serial numbers

  • Record / decommission serial numbers in goods receipt  

  • Aggregate / de-aggregate serial numbers

  • Aggregation of own and third-party 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 assigned work orders / process orders of a line

  • Communication to Level 4 and Level 5 systems

 

We recommend the following modules to implement your EU FMD compliance:​

Module:

b+b site server

Utility for interface and data automation, license handling

b+b site manager

Management of users/user groups - detailed assignment of rights
Management of reporting permissions
Work order management (new/edit/archive/prioritization) - Assignment to the production line
Audit Trail - research
Administration of customer|market|product master data|serial number logic|GLN number
Management of 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 line manager

Level 2 software component for parameterization and control of the line components

b+b line manager aggregation

Level 2 software component for parameterization and control of the line components
with aggregation (ePedigree = electronic family tree)

b+b Storage List Module

Module for capturing verified codes to create stock lists/pallet waybills

b+b Packing List Module

Module for entering codes (including aggregation codes) in outgoing goods, including assignment of shipping numbers, packing list numbers, etc.

LabelsPlatform

Program for creating layouts and communicating with printing systems

We recommend these additional modules to implement your EU FMD compliance as a RE- or PARALLEL IMPORTER:​

b+b Work Order Label Module (WOLM)

Label printing and production order creation with monitoring of the printing progress with print preview

b+b entrance modules

Module for entering codes in goods receipt, including assignment of goods receipt numbers/container numbers or optional customer numbers.

b+b repack modules

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 when automatic camera control is not possible

We recommend these additional modules to implement your EU-FMD compliance as a WHOLESALER:​

b+b entrance modules

Module for entering codes in goods receipt, including assignment of goods receipt numbers/container numbers or optional customer numbers.

b+b site server / b+b site manager:

User and rights management

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

  • Audit trail (similar to 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 of the complete software modules.

Main_de_SM_CRISTAL.PNG

b+b Sitemanager 

A Windows VM and an MS SQL Server database are provided by the customer. The b+b SiteServer can be operated either as an ON-PREMISE or CLOUD installation.

The SQL Server database is provided with the required table structures by b+b. The customer receives read access to the table data.