ThermoFisher Using Chromeleon 7.3 CDS User Manual
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Using Chromeleon 7.3 CDS to comply with regulations
2
3
Agenda
4
Data
Technical Controls
Procedural Controls
Qualification
• Compliance layers
• Compliance must be combination of technical and procedural controls
Built for Compliance
Data
Technical Controls
Procedural Controls
Qualification
5
• Software must be capable of 21 CFR Part 11 compliance
• Compliance can be considered
in four categories:
• Security
• Access control and data security
• Record Management
• All data stored, controlled
and archived
• Audit Trails
• Traceability of all actions in CDS
• No loss of productivity
• Qualification
• Verify correct performance
• Time/costs must be minimized
Built for Compliance
6
• Multiple levels of access security
Built for Compliance – Security
Data Vault
Data Vault
Service
Raw Data Files
SQL Server
or Oracle
Database
User
Management
Service
License Service
Local System/IT Administrator
User Database
License File
Instrument
Controller
Instrument
Configuration
Scheduler
Windows User
Chromeleon CDS User
Chromeleon CDS Administrator
Chromeleon CDS Super User
Increasing security
Instrument
Configuration
Manager
Administration
Console
Console &
Studio
Relational
database
7
• Comprehensive user management
• Create unlimited users, roles and
access groups
• Role is collection of privileges
• Defines what user can and cannot do
• User can be assigned different roles
• At login can choose an assigned role
• Access and roles can be controlled at
every level
• Data Vault, Folder, Instrument
Built for Compliance – Security
8
• Data security
• No loss of data and 24/7 lab uptime with
Network Failure Protection (NFP)
• License and User Management information cached locally
• Instrument and user licenses always available
• Users can always logon and continue to work
• XVault technology ensures continuous operation
• NFP mode automatically enabled at network failure
• Uninterrupted data acquisition
• After network recovery, data automatically uploaded to central server
• User can log on to instrument controller to view and edit running queue,
submit new analyses, process and report data
• User management active to ensure data security
• All information and actions are audited and traceable to protect data integrity
Built for Compliance – Security
Network
Data Vault
Chromeleon CDS
Workstation
Instrument
Controller
9
• Flexible data organization options
• Integrated electronic signature functions
• Automatic scheduler tool for archiving
• Exporting in FDA-approved formats
Built for Compliance – Record Management
10
Flexible Data Organization
• Data Vault concept
• Mount multiple Data Vaults
• Local, regional and/or global
• Mount Chromeleon 6 CDS
Datasources
• Controlled access
• Flexible folder structure
• Can organize by anything, e.g.
project, location, date, user,
instrument, etc.
• Controlled access
Built for Compliance – Record Management
Flexible folder structure
11
Electronic Signatures
• 3 Levels of signature Submit, Review, Approve
• Applied to electronic report
• Complete sequence protected by checksums
• Controlled by privileges
Built for Compliance – Record Management
12
Built for Compliance – Record Management
Scheduler for Automatic Archiving
• Automatically move data by combining powerful injection queries with the Scheduler
• Easily organize your system
13
Exporting
• Chromeleon CDS provides automatic printing or
exporting of sequence results with just two clicks
• Print or export results in various formats, e.g.
• PDF or spreadsheet for client
• Result export as text or GAML file for LIMS
• Multiple output formats for all purposes
• Text (TXT, CSV)
• Excel (XLS)
• Portable document format (PDF)
• Generalized Analytical Markup Language (GAML)
• AnDI/NetCDF (CDF)
• Raw File (RAW)
• Chromeleon Data File (CMBX)
Built for Compliance – Record Management
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