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:
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User and rights management
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Audit Trail (in all modules)
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Customer / target market management
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article management
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Work order management/process order management
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Serial number management (optional)
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line management
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interface management
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label layout management
FEATURES:
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Create / edit / import workorder / process orders
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Reporting to n markets/customers/databases
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Parameterization and communication of connected line managers (Level 2)
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Overview of Workorders/Process Orders Assigned to a Line
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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:
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User and rights management
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Administration of database data
(automatic backups, data cleansing, import/export) -
Audit Trail (analog CFR 21 Part 11)
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Customer / target market management
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Article and print layout management
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Work order management/process order management
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Serial number management (optional)
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line management
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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.
