Chromatography Data System: Comply with Regulations

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Chromeleon CDS Seminar

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Comply With Regulations

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Introduction

• Software needs to meet regulatory requirements• Software must be 21 CFR Part 11 compliant for electronic

signatures:• 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

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Introduction

• 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

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Compliance – Security

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Security - User Management

• Create Users, Roles and Access Groups

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User Management Roles

• A role is a collection of privileges• Defines what a user can and cannot do

• A user can be assigned different roles• At logon a user can choose an

assigned role

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Controlled Access in Console

• Access and roles can be controlled at every level

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Controlled Access in Console

Full Data Structure

Only R&D FoldersJust QC Folders in

Location 1

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Control of Access to Instruments

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Compliance – Audit Trails

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Audit Trails provided by Chromeleon CDS

• Security logs• Instrument activity event logs• Modification history (object audit trails)

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Security Log

• User management

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Instrument Daily Event Log

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Instrument Daily Event Log for each Sample

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• Displays complete change history of each object

Modification History

All Audit Trails can be searched, grouped and filtered

Restore to Previous Version

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Modification History – Version Comparison

Changes in objects are easily identified

Change

AdditionDeletion

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Compliance – Record Management

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Record Management with Chromeleon CDS

• Flexible data organization options• Integrated electronic signature functions• Automatic scheduler tool for archiving• Exporting in FDA-approved formats

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Record Management – Electronic Signatures

• 3 Levels of signature Submit, Review, Approve

• Applied to electronic report

• Complete sequence protected by checksums

• Controlled by privileges

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Record Management – Electronic Signatures

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Compliance – Qualification

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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

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Qualification

• 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 possible

• 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.

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Qualification – Certificate of Validation

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Qualification – Station IQ

• Fully automated• Takes <2 mins• HTML based Qualification

Report• Modern layout

• Overview:• Expanding/collapsing details

• Summary on the top

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Modern looking, HTML based

Details expanded

Details collapsed

Summary

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Qualification – Station OQ

• Fully automated• Takes <7 mins• Comprehensive

• Checks software operation

• Includes Report Designer Pro functionality check

• Complete Qualification Report

• Stored in Data Vault (user defined location)

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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 correct operation

• Runs series of sequences depending on installed modules

and options

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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

common tests• Evaluate SST Results

offline, or as your samplesare analyzed

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Summary

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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

workflow• History views of objects track changes and easily revert to

prior versions• 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

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Summary – Bringing It All Together

Audit Trails

Record ManagementSecurity

Qualification

Chromeleon CDS has all the tools to help you ensure regulatory compliance

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Thank You!

Any Questions?