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There are many challenges facing laboratories when it comes to compliance, including meeting regulatory, 21 CFR Part 11 and qualification requirements. Qualification and compliance can be a very time-consuming aspect of CDS installation and maintenance and it is important that the software can accomplish this with minimal impact on the day-to-day operation of the system. Furthermore, it should be easy to re-qualify at regular intervals according to the customers requirements.
Compliance can be considered in four categories:Security – this encompasses system access control and data security.Audit Trails – all actions and events within the CDS should be fully traceable.Record Management – all data should be stored, controlled and archived accordingly.Qualification – all aspects of the CDS installation need to be qualified to prove it is installed and working as expected.
With the User Manager an administrator can define who can use Chromeleon CDS (USERS), which privileges a user has (ROLES), and which areas of the software an operator can use (ACCESS GROUPS).
So what are roles? Roles determine the users privileges within the software which in turn determine what they are allowed to do.One user can have several roles e.g. a power user may not require the ability to edit reports when working day-to-day. Two roles can be assigned for these two scenarios and the user can choose the role at logon.
Access to folders can be assigned to individual users or groups of users and at the role level.
In this example you can see the entire folder structure of a central Data Vault. <Click>The next user has access to the folders of the R&D labs of all locations. <Click>Finally the next user only has access to the folders of the QC.
There is also an object audit trail, which displays a complete change history of the selected object. It is easy to rollback to a previous version, and to compare different versions.
This is an example of version comparison, where changes are easily identifiedAll changes are marked with a red exclamation markAll additions are marked with a green plusAll deletions are marked with a red cross.
Electronic signatures ensure the authenticity and integrity of electronically reported data. Three levels of electronic signatures can be used. The signature is applied to an electronic report, which is the snapshot of the data. After signing the complete sequence, including all files used to generate the data, like the instrument method, processing method, etcetera, is protected by checksums and can no longer be modified. All signature steps can be controlled by privileges.
Full automation means less time and therefore less cost for qualification. It also ensures reproducibility from operator to operator and system to system. Further, the automated qualification processes can be performed by the customer at any time, again saving time and money.
The software itself is fully validated and the certificates are available on the software distribution disc.
Once the IQ is finished, we can see the IQ report. It isHTML based and has a modern layout. It provides easier overview, because:<Click>: it starts with the Summary<Click>: and details can be expanded and collapsed,
The fully automated OQ is fast and checks all aspects of the software. The resulting data can be electronically signed and stored in the Data Vault.
The Instrument IQ provides a communication test to qualify the link between the already qualified software and the instrument itself.The Instrument OQ checks the performance of the instrument in place on the laboratory bench.
Adding versatile system suitability tests ensure the chromatography quality. The tests are fully customizable, so every chromatography parameter can be tested. Of course there are many predefined templates for the most commonly applied tests. When setup, the tests can be evaluated offline, for example in the report template, or while your samples are being analyzed.
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Chromatography Data System: Comply with Regulations
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Comply With Regulations
• Software needs to meet regulatory requirements
• Software must be 21 CFR Part 11 compliant for electronic
• Controlling system access
• Tracking system activities
• Managing system data
• Verifying correct performance
• No loss in productivity
• Avoid time consuming manual qualification procedures
• Re-qualification costs must be kept to minimum
• Compliance can be considered in four categories:
• Security - this encompasses system access control and data
• Audit Trails - all actions and events within the CDS should
be fully traceable
• Record Management - all data should be stored, controlled
and archived accordingly
• Qualification - all aspects of the CDS installation need to be
qualified to prove it is installed and working as expected
Qualification Tools included with Chromeleon CDS
• Provides a complete set of qualification procedures (AutoQ™)
• Certificate of Validation
• Automated Software IQ and OQ
• Automated Instrument IQ and OQ
• Automated System Suitability Testing
• Qualification processes are fully automated (with
occasional, minor manual interaction for instrument IQ/OQ
e.g. pump priming)
• Therefore qualification can be performed in as short a time as
• All processes are available as standard, therefore
requalification can be performed by the customer. This
ensures down time and cost is kept to a minimum.
Qualification – Station IQ
• Fully automated
• Takes <2 mins
• HTML based Qualification
• Modern layout
• Expanding/collapsing details
• Summary on the top
Modern looking, HTML based
Qualification – Station OQ
• Fully automated
• Takes <7 mins
• Checks software operation
• Includes Report Designer Pro
• Complete Qualification Report
• Stored in Data Vault (user
Qualification – Instrument OQ
• IQ: Checks communication between the CDS and selected
instruments to verify instrument is correctly installed
• OQ: Checks performance of selected instrument to verify
• Runs series of sequences depending on installed modules
Qualification – System Suitability Test (SST)
• Built-in SST functionality – no license required
• Setup versatile SSTs to ensure chromatography quality
• Fully customizable
• Templates for the most
• Evaluate SST Results
offline, or as your samples
Summary – The Chromeleon CDS Solution
Thermo Scientific™ Dionex™ Chromeleon™ CDS meets all of
your regulatory compliance needs with:
• Multi-tiered security for controlling access with
comprehensive user management tools
• Comprehensive tracking of all actions without hindering
• History views of objects track changes and easily revert to
• Complete record management with direct access to meta-
data and full electronic signature support
• Powerful built-in, automated qualification tools for all aspects
of system operation
Summary – Bringing It All Together
Chromeleon CDS has all the tools to help you
ensure regulatory compliance