b + b software modules
the modular software basis for labeling of your medical devices
Software for serializaton in 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.
