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
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.
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.
