Updated Compliance 21 CFR Part 11 Solution ChemStation 021809 · ChemStation E-Seminar Agenda...

ChemStation E-Seminars

ChemStation 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


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


Feb, 2009

Introduction to OpenLAB and the OpenLAB Enterprise Content Management (OpenLAB ECM)


Feb, 2009

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.


Feb, 2009

Agilent OpenLAB Architecture


Feb, 2009

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


Feb, 2009

…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.


Feb, 2009

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.


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


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.


Feb, 2009

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.


Feb, 2009

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.


Feb, 2009

The ChemStation OpenLAB Option


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


Feb, 2009

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


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


Feb, 2009

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


Feb, 2009

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


Feb, 2009

Moving forward to Agilent ChemStation / OpenLAB OpenLAB Option

Data Workflow in the ChemStation OpenLAB Option


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!


Feb, 2009

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


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)


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


Feb, 2009

ECM Menus / Icons

Data Analysis View Report LayoutMethod and Run Control

If not all items are present, enable the Fullenable the „Full menu“


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


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


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


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


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.


Feb, 2009

Internal Update Training B.04.01Agilent Restricted

information about the error that prevented the upload.

Compliance Features in the ChemStation OpenLAB Option


Feb, 2009


Enabling Method and Results Audit Trails


Feb, 2009


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.


Feb, 2009


The Results Audit Trail


Feb, 2009


The ChemStation OpenLAB OptionUsing the OpenLAB Intelligence Reporter


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


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


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


Feb, 2009

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


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


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)


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


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)


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


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


Feb, 2009

Updated Compliance 21 CFR Part 11 Solution ChemStation 021809 · ChemStation E-Seminar Agenda...

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