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
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 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 multipack manager
enables the creation of cross-GTIN multipacks and aggregation to a new serial number
LabelsPlatform
Program for creating layouts and communicating with printing systems
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.
