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serialization software

for medical devices

 

b+b trace > software > medical technology

Software for serialization in medical technology

Extensive modules and features are available for the implementation of the Medical Device Regulation (MDR) 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 (optional)

  • line management

  • interface management

  • label layout management

features

  • Create / edit / import work orders / process orders

  • 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

UDIsample.PNG

We recommend the following modules to implement your UDI 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/ prioritize) - Allocation to the production line
Audit Trail - research
Management 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)
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 the line components

b+b Linemanager Aggregation

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

b+b Multipackmanager

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

LabelsPlatform

Program for creating layouts and communicating with printing systems

Main_de_SM_CRISTAL.PNG

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 (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 of the complete software modules.

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.