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ChemStation E-Seminars
Page 1ChemStation E-Seminar
Feb, 2009
ChemStation E-Seminar Agenda Schedule Short description AgilentSchedule Short description Agilent
Speaker
15. Oct. 2008 ChemStation Data Storage Concept Steven Brown
Ortrud Emde
12. Nov. 2008 ChemStation Navigation TableHow to improve Review and Reprocess
Steven Brown
Ortrud EmdeOrtrud Emde10. Dec. 2008 Integrating My Results in ChemStation Steven Brown
Ortrud Emde
14. Jan. 2009 How to set up a calibration table in ChemStation Steven Brown
04. Feb. 2009 Various Reporting in Chemstation Steven Brown
Ortrud Emde
18. Feb. 2009 Updated Compliance 21 CFR Part 11 solution with Agilent ChemStation & OpenLAB ECM
Steven Brown
Ortrud Emde
Page 2ChemStation E-Seminar
Feb, 2009
Ortrud Emde
Seminar 6: Updated Compliance 21 CFR Part 11 solution with Agilent ChemStation & OpenLAB ECM
Topics
Introduction to OpenLAB Enterprise Content Management (OpenLAB ECM)( p )
The ChemStation integrated into OpenLAB
Data Workflow ChemStation integrated with OpenLABData Workflow - ChemStation integrated with OpenLAB
Compliance Features - ChemStation integrated with OpenLAB
ChemStation and OpenLAB - Using the OpenLAB Intelligence Reporter
Page 3ChemStation E-Seminar
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Introduction to OpenLAB and the OpenLAB Enterprise Content Management (OpenLAB ECM)
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Scope
• This presentation provides an overview of the functionality of OpenLAB ECM most important to ChemStation integration.p p g
• OpenLAB ECM provides a lot more functionality which is not covered in this short introduction.
• If you want to know more about e.g., archiving, record retention, or OpenLAB Business Process Manager (BPM) f ti lit t t l tfunctionality, contact your sales team.
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Agilent OpenLAB Architecture
Page 6ChemStation E-Seminar
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A library preserves knowledge
OpenLAB ECM is an electronic library...OpenLAB ECM is an electronic library...
• Information is indexed
• Users are registered and logged
• File history is maintained• File history is maintained
• Index can be searched
• Trail of who has what item
• Trail of when an item was received
• Old information is archived
that preserves electronic knowledgethat preserves electronic knowledge
• System is secure
Page 7ChemStation E-Seminar
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…that preserves electronic knowledge…that preserves electronic knowledge
Agilent OpenLAB ECM – Store any data
Store
Manage
Archive
your data in Agilentyour data in Agilent OpenLAB ECM.
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OpenLAB ECM provides Compliance with 21 CFR Part 11Compliance with 21 CFR Part 11
Full compliance with Part 11 security requirements
• Complete record security
• Audit trails
• Check in/ Check Out of Files• Check in/ Check Out of Files
• Record version control
• Searching
• Archiving
• 21 CFR Part 11compliant electronic signatures
Revision History• OpenLAB ECM contains a complete revision history of all files it maintains.• All file versions are available for inspection and/or use, if required.
Page 9ChemStation E-Seminar
Feb, 2009
Electronic Signature
Y l ECM l t i Si tYou can place an ECM electronic Signatureon any file in ECM.The Acrobat plug-in Signature places a visible eSignature on a PDF file. It requires Ad b A b t F ll
Page 10ChemStation E-Seminar
Feb, 2009
Adobe Acrobat Full.
OpenLAB ECM: Secure data storage
Secure repository for storage of raw data and reports prevents direct access for compliance with 21 CFR 11 and GMP/GLP.
Records can be archived for long-term retention with HP FSE, IBM Tivoli, SAN or content addressed storage, such as EMC Centera
O LAB ECM
Centera.
Database for theOpenLAB ECM Application Infrastructure
Database for the storage of metadata and all application and user settings.
Access to the OpenLAB ECM application and data files is via a web browser. User log-on credentials are checked against the database settings.
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Location / Cabinet / Drawer / Folder Structure
LocationCabinetDrawerFolder
Files in ECM are organized in an intuitive Location / Cabinet / Drawer / Folder hierarchy. Files are stored in the l l l f h hi h h F ldlowest level of the hierarchy, the Folder.
Page 12ChemStation E-Seminar
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Searching in OpenLAB ECM
There are different ways of searching. One way is to start a Google-like search (or Quick Search) from the ECM web client.
Page 13ChemStation E-Seminar
Feb, 2009
The ChemStation OpenLAB Option
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Feb, 2009
ChemStation OpenLAB Option Main Data Flow
ECM DB + StorageECM DB + StorageChemStationChemStation User ActionsUser Actions
1. Store data in ECM(ssizip)
2. Retrieve data from ECM(ssizip)(ssizip)
3. Report on Data from ECM in ChemStation
4 R t D t f4. Report on Data from ECM using any OLIR Client
Page 15ChemStation E-Seminar
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ECM Roles and their Privileges
Default ECM Roles
Short description Details
CSOperator Basic operational functions for Data GenerationAdobe Acrobat
Document
CSAnalyst Operational Functions for Data Generation and Data Analysis Adobe Acrobat
Document
CSLabManager Operational Functions for Data Generation, Data Analysis and Instrument Configuration
CSAdministrator ChemStation Administration Instrument
Adobe Acrobat Document
CSAdministrator ChemStation Administration, Instrument Configuration, and Queue Management Adobe Acrobat
Document
Page 16ChemStation E-Seminar
Feb, 2009April, 2008
ChemStation B.04.01 User Privileges & Roles in ECM
Predefined roles• Administrator
• Lab ManagerLab Manager
• Analyst
• Operator
User privileges:• Comprehensive list of
user privileges
Customize• Set up new roles
• Modify existingModify existing roles
• Assign ECM users to roles
Page 17ChemStation E-Seminar
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ChemStation Admin Tool –supporting Compliance Configurationssupporting Compliance ConfigurationsTwo Possibilities:
Use settings from• Use settings from ChemStation preferences
• Use these settings for all instances on this
tcomputer– Transfer Management
SettingsSettings– Audit Trail
Page 18ChemStation E-Seminar
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ECM User Logon
CUse the ECM user login to secure the ChemStation data and methods in ECMUsers, passwords & policies will follow ECM standardsChemStation in compliance mode requires a mandatory login to ECM
Page 19ChemStation E-Seminar
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Moving forward to Agilent ChemStation / OpenLAB OpenLAB Option
Data Workflow in the ChemStation OpenLAB Option
Page 20ChemStation E-Seminar
Feb, 2009
ChemStation/ECM Workflow – Data Acquisition
ECM DB + StorageECM DB + Storage
ChemStationChemStationVersion
1Version 2
1. Data Acquisition(version 1)
2. Review of running( i 2)
Optional Cleanup:sequence (version 2)
Version
Local deletion of data when ChemStation is closed
1 Version 2
Protected Protected data storagedata storage
Please finalize review. Data will now be saved to ECM!
Page 21ChemStation E-Seminar
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ChemStation/ECM Workflow – Data Review
ECM DB + StorageECM DB + StorageChemStationChemStation
Version 1Version
2
2. Review or Reprocess(creates version 3)
Version 2 Optional Cleanup:
Version 33. Load next data set
or close
New version will be saved to ECM!
Local deletion of data when ChemStation is closed
Page 22ChemStation E-Seminar
Feb, 2009
Transfer Settings
Transfer Setting What happens
After Acquistion Directly after data acquistion, the data are transferred to a specified folder in ECM, a first version is generated
After Reprocess ECM data downloaded to the ChemStation HD are reprocessed back to ECM
After any Data If a new result is created, the system forces an upload ofAfter any Data Modification
If a new result is created, the system forces an upload of the data set to the storage location; a new version is generated
Import after reprocess Data (not yet present in ECM, just present on the Harddisk) are transferred to ECMHarddisk) are transferred to ECM
Always calculate Peak Performance
Enable this option to ensure that peak performance data are generated and uploaded with the data set to ECM (to
h l i i d)
Page 23ChemStation E-Seminar
Feb, 2009
get them later, a reprocess is required)
Transfer Preferences to OpenLAB ECM
The path specifies the inital storage location for data• The path specifies the inital storage location for data uploaded to ECM for the first time, to generate a first version
• Possible to specify the path or to use ChemStation Token• Possible to specify the path, or to use ChemStation Tokenfor the Drawer/Folder in ECM, the tokens are created in ECM during the data upload
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ECM Menus / Icons
Data Analysis View Report LayoutMethod and Run Control
If not all items are present, enable the Fullenable the „Full menu“
Page 25ChemStation E-Seminar
Feb, 2009
ECM Related Information generated by the GUI (1)
The currently logged on user is visible at the bottom right of the gChemStation window
Tool tip shows the LCDF path and version for method/sequence templates/data
Ri ht li k t ECMRight-mouse click to access ECM properties for ECM related details
Icon indicates ECM relationIcon indicates ECM relation
Page 26ChemStation E-Seminar
Feb, 2009
How to handle ECM items in ChemStationibl l d ECM M th dpossible load ECM Method,
Sequences and Data using Tool Bars or the ECM Menu
possible to search for the item in question (depending on the filter keys)
item is direcltly loaded in M th d/R C t l D tMethod/RunControl or Data Analysis
ECM items are indicatedECM items are indicatedin CS Explorer
Page 27ChemStation E-Seminar
Feb, 2009
Check in/ Check Out ECM Methods, Sequence, DataData
to prevent other users from altering your method, it is possible to open the
th d/ t l t h k dmethod/sequence template as „checked out“
to check it in, the user in question can „undo the check out“ using the right mouse click option in the CS Explorer
or the privileged person can run an „undoor the privileged person can run an „undo check out“ in the ECM Client
or if the „clean up data on shut down“ is enabled the item is check in during theenabled, the item is check in during the next ChemStation closure
Page 28ChemStation E-Seminar
Feb, 2009
Clean Up of ECM Items in ChemStation
possible to clean up ECM Method and Sequences using the Delete option in the File Menu
Automatic Data clean up on shut-down
man al clean p possiblemanual clean up possible
Page 29ChemStation E-Seminar
Feb, 2009
Queue Management
When upload to ECM fails (e.g. due to Network Outage), the items to be uploaded are not lost, but queued. The Queue Management dialog allows to work on the items in the queue.
The dialog can be called from the ECM menu in Data Analysis view or automatically when connecting to the ECM server if items are in the queue (Preferences).q ( )
The dialog provides a list of all items queue, including information about the error that prevented the upload.
Page 30ChemStation E-Seminar
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Internal Update Training B.04.01Agilent Restricted
information about the error that prevented the upload.
Compliance Features in the ChemStation OpenLAB Option
Page 31ChemStation E-Seminar
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Internal Update Training B.04.01Agilent Restricted
Enabling Method and Results Audit Trails
Page 32ChemStation E-Seminar
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Internal Update Training B.04.01Agilent Restricted
Viewing the Method Audit TrailWhen Method Audit Trail is enabled all changes of data analysisWhen Method Audit Trail is enabled, all changes of data analysis parameters of the method are tracked in detail by system generated entries.
Page 33ChemStation E-Seminar
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Internal Update Training B.04.01Agilent Restricted
The Results Audit Trail
Page 34ChemStation E-Seminar
Feb, 2009
Internal Update Training B.04.01Agilent Restricted
The ChemStation OpenLAB OptionUsing the OpenLAB Intelligence Reporter
Page 35ChemStation E-Seminar
Feb, 2009
OpenLAB Intelligence Reporter
to view, click on the report
Some Example Report Solutions
Single Sequence Report – Directly in ChemStation: Sequence overview, marking of manual integration, statisitc calculation per calibration level / per compound
Diagnostic Report (Cross Sequence):Based on diagnostic data (pressure), sequence overview about pressure drops during a sequence series
Instrument Maintance Report (Cross Sequence): Colum Usage Report, per column, per Instrument over the time
Cross-Sequence Trend Charts (Cross Sequence):cross sequence report for statistic calculations on various compounds, per level
Page 36ChemStation E-Seminar
Feb, 2009
One Example Single Sequence OpenLAB IR
Report header with company logo
Sequence information
Sequence table
Results for calibration standards per Level
Statistical calculations
Results for quality control samples, grouped by sample name
Page 37ChemStation E-Seminar
Feb, 2009
Select Report Template for OpenLAB IR• Save the Report• Save the Report
template *.rdl with the sequence.s file, as part of the sequencepart of the sequence output dialog
• After acquiring or reprocessing thereprocessing the sequence data, the report can be created in Data Analysis viewin Data Analysis view
• Report Templates are under version control
Page 38ChemStation E-Seminar
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Generate an OpenLAB Intelligence Reporter
• In Data Analysis use menu or icon to generate OpenLAB IR
• The data need to be present in the Navigation Table
• OLIR icons/menu only present, if option installed within OpenLAB ECM
Page 39ChemStation E-Seminar
Feb, 2009
Information on ChemStationDocumentation can be found on the Agilent websiteghttp://www.chem.agilent.com/Scripts/PDS.asp?lPage=61233
•Product Datasheet•Specification•Application Notes•Manuals
OpenLAB Intelligence Reporter http://www.chem.agilent.com/Scripts/PDS.asp?lPage=61233
M l b f d Ch St ti I t ll ti DVDManuals can be found your ChemStation Installation DVD
•Getting Started with New ChemStation WorkflowPartNo.G2170-90042
•Understanding your ChemStationPartNo. G2070-91125
•OpenLAB OptionPartNo.G2170-90233
Software Status Bulletinhtt // h il t / US/S t/D l d /P t h /P /d f lthttp://www.chem.agilent.com/en-US/Support/Downloads/Patches/Pages/default.aspx
Customer Trainings (NorthAmerica)
http://www.chem.agilent.com/cag/training/northam/index.asp
Page 40ChemStation E-Seminar
Feb, 2009March, 2008
Learning Products – North America Course CatalogCatalog
Users needing to increase productivity in the lab by utilizing both standard and advanced features available in the Agilent GC/LC ChemStation may want to attend one of the following courses:
H2606A - ChemStation for GC Data Analysis and Reporting (2 days)
H5928A - Agilent HPLC (2D) Data Analysis and Reporting (2 days)
H4039A - Agilent HPLC (3D) Data Analysis and Reporting (3 days)
Course Features
Data acquisition and method creationData analysis including integration and calibrationSequencingReportingReporting
For more information concerning course content, dates and locations, please visit:
http://www chem agilent com/en-US/education/en-us/classroomtraining/Pages/Courselisting aspx
Page 41ChemStation E-Seminar
Feb, 2009
http://www.chem.agilent.com/en US/education/en us/classroomtraining/Pages/Courselisting.aspx
Learning Products – European Course Catalog
Users needing to increase productivity in the lab by utilizing both standard and advanced features available in the Agilent GC/LC ChemStation may want to attend one of the following courses:
H4033A – Agilent HPLC (3D) Method&Run Control, Data Analysis and Reporting (4 days)
H8718A - Agilent HPLC (3D) Data Analysis and Reporting (2 days)
H5928A – Advanced User Training, Quantification and Result Reporting (2 days)
Course Features
Data acquisition and method creationData analysis including integration and calibrationSequencingReportingReporting
For more information concerning course content, dates and locations, please visit:
htt // h il t / US/ d ti / /h
Page 42ChemStation E-Seminar
Feb, 2009
http://www.chem.agilent.com/en-US/education/pages/homepage.aspx
Who to contact for more information about OpenLAB and Agilent software productsOpenLAB and Agilent software products1. Agilent Account Managers (sales)
2 Agilent Informatics Product Specialists2. Agilent Informatics Product Specialists
Eastern US - Marc Mandelbaum – 302-683-7149
Pacific Coast (CA WA OR) Spencer Tse 408 553 3655Pacific Coast (CA, WA, OR) - Spencer Tse 408-553-3655
Midwest and South - Johnathon McSayles 847-944-6019
Midwest /West/Latin America Stephen Brown 847 944 6461Midwest /West/Latin America – Stephen Brown 847-944-6461
Page 43ChemStation E-Seminar
Feb, 2009