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b + b software modules

the modular software basis for labeling of your medical devices

Extensive modules and features are available to implement Medical Device Regulation (MDR) 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 (optional)

  • line management

  • interface management

  • label layout management

FEATURES:

 

  • Create / edit / import workorder / process orders

  • 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 implement your UDI 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)
Multipack parameter management

Serial Number Management| Aggregation Level Management|Reworking|Sampling
Message status display
Decommissioning of reported products (destruction during transport)

b+b ERP Link

Interface to your ERP system

b+b Repository Link

Interface to Level 5 (EUDAMED)

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 Multipackmanager

enables the creation of GTIN-spanning multipacks and aggregation to a new serial number

LabelsPlatform 4 Premium

Program for layout creation and communication with printing systems - LINK

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 (optional)

  • 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.