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July 2007

Ensuring Data Integrity in the Pharmaceutical Environment

Kathleen O’DeaSenior Product ManagerSoftware and Informatics Division

Agilent Software & Informatics Solutions

Ensuring Data Integrity in the Pharma EnvAgilent Restricted

June, 2007

From Research & Development science to

QC batch release of latest blockbuster drug

The confidence you need in the data you produce 24 hours per day, seven

days per week


June, 2007

Chemical AnalysisChemical AnalysisLife SciencesLife Sciences

Petrochemical QAEnvironmental TestingFood TestingForensics

Disease & Drug DiscoveryDrug DevelopmentClinical TrialsDrug Manufacturing-QA/QCDiagnostics

Life Sciences and Chemical AnalysisBusiness Portfolio with a Software / Informatics foundation

SOFTWARE and INFORMATICS


June, 2007

Life Sciences and Chemical AnalysisGrowth Strategies for Laboratory Informatics

• Complete laboratory informatics portfolio with data integration across the lab and beyond

• Broadest range of analyticaltechniques and applications

• Support for diverse instruments from multiple vendors, with superior control of Agilent equipment

• Open systems architecture with interoperability

• Industry-leading support

Managing information across the lab and beyond

New Capabilities

Multi-technique Data Collection,Analysis and Interpretation

InformationManagement

Scalable,Open Systems


June, 2007

The Pharmaceutical LabHow can Agilent Software & Informatics help?

• Centralized data storage

• Minimize impact to existing workflows to reduce training costs

• Track and audit all data access / activities

• Protect data from unauthorized access

• Make data available to authorized users when and where they need it

• Search for all related data with a single query

• Allow users to more easily share data

• Remove bottlenecks in the review and approvals process

• Allow users to more easily use and re-use data in generating reports

• Manage data through its entire lifecycle

• Scalable to meet the needs of your environment


June, 2007

Agilent Informatics SolutionsA unifying software platform built on a strong foundation


June, 2007

Centrally Store and Protect All DataContent Management Capabilities

Manage and organize ALL electronic content regardless of source

•• Analytical DataAnalytical Data•• Chromatography resultsChromatography results•• Photographs and images Photographs and images •• PDF files and formsPDF files and forms•• Scanned paper filesScanned paper files•• EmailEmail•• Microsoft Office filesMicrosoft Office files•• Electronic reportsElectronic reports•• ANY electronic contentANY electronic content


June, 2007

Data Integrity Ensure data remains unchanged

• When a file is added to ECM an MD5 hash checksum is calculated on the file in its original client location.

• The file is then copied to ECM – where another MD5 hash checksum is calculated.

• Only if these values are identical is the transfer considered successful and the file is removed from the client location.

• The checksum is saved as part of the file’s metadata (any data that describes the data file).

• Any time the file is accessed in any way –to be retrieved, signed, moved, emailed, reanalyzed, archived – the MD5 hash checksum is recalculated and compared to that original value.


June, 2007

Minimize Impact to Existing WorkflowAutomated Content Transfer

Automate file upload

• Scheduler monitors computers, drives, folders for files that meet user defined upload criteria

• Remove files from client locations automatically

• Specialized interfaces for analytical applications that generate groups of files or directory structure

• CyberPrinter XP manages electronic files printed from Windows based applications


June, 2007

Minimize Impact to Existing WorkflowAccess ECM files from familiar Desktop applications

Integration with Desktop Applications like Microsoft Office, Adobe Acrobat

• Open and Save files directly to the content repository

• Small OpenLAB toolbar mimics application functions

• Search the content repository from with the Desktop application

• Compare documents or document versions stored in the repository


June, 2007

Minimize Impact to Existing WorkflowChemStation Integration with OpenLAB ECM

Access common ECM functionality directly from the ChemStation UI

• Load and save methods, sequences, and data directly from ECM

• Access to files stored within ECM without leaving ChemStation.

• Access to all ECM search functionality is available inside ChemStation


June, 2007

Keep Track of all Steps in Data AnalysisVersion Control

A complete revision history of all files

• Users can review previous versions

• Users can compare file versions• Users can roll back to previous

versions if necessary


June, 2007

Track all File Access and Activity Audit and System Logs

Every activity within the system is logged

• The audit trail is computer generated and time stamped with GMT based time line

• The audit trail is fully searchable, exportable, and printable

• A variety of views into the audit trail are provided from file based, system based, instrument based to the full audit trail content.


June, 2007

Track Changes within some Document TypesRemediation Services for Excel Spreadsheets

View the entries for View the entries for a single cella single cell

Or the entire Or the entire spreadsheetspreadsheet

Cell by cell auditing capabilities for Excel spreadsheets

• Audits cell content changes

• Audits cell formula changes

• Audits macro changes

• Each audit trail entry captures:

• Date / time of edit

• User ID

• Worksheet name and cell position

• Old value

• New value

• Description of the change

• Reason for the change


June, 2007

Protect your Data from Unauthorized AccessControlled User AccessAccess to the system is controlled through roles and permissions

• The user sees only the instruments, content, and software functions that they have the permissions to interact with

• Roles can be assigned system wide, or on an instrument by instrument, project by project, folder by folder basis

• User roles within the Instrument are defined by projects

• Projects link users with instruments with content.


June, 2007

Keep Data Useful and AvailableExtracting searchable information automatically

Metadata extraction with filters

• Metadata associated with files can be searched and reported against

• Filters programmatically extract metadata from files as part of the upload process

• With no user interaction, metadata is extracted and stored with the file

• Filters are drop in, server modules that can be added to the system at any time with no application down time


June, 2007

Keep Data Useful and AvailableExtracting searchable information in context

Metadata extraction from any instrument / any manufacturer

• User entered fields extracted from PDF forms

• Reports printed from any analytical instrumentation

• Metadata keys can be found and extracted from the PDF file content

• Extracted information can be searched in contextFor example: Find file where Project Name = XYZ


June, 2007

Tag Stored Files with Important InformationUser Defined Metadata

Associate user defined metadata to files

• Users can add this type information to the file’s metadata with User Defined Keys

• These values can be automatically assigned, entered by users, selected from defined pick lists, or entered programmatically

• This information is also fully searchable with any of OpenLAB’s search mechanisms


June, 2007

Find All the Data You Need - FAST3 Levels of Search Tools

The quick search tool is a web style search

• Web style search – just enter search text and go

• “Smart” search that guides users through query statements

• Advanced search for more extensive data mining


June, 2007

Approve Results and Reports Electronic Signatures

Any file within Content can be Electronically Signed

• PDF file signatures accomplished with plug-in for Adobe Acrobat

• This plug-in encrypts signature information within the document and displays a visible indication of signature on the file

• A generic signature tool is used to apply electronic signatures to any file type

• Each signature contains the date / time of the signing, the name of the signer, location that the signature took place and reason for the signature


June, 2007

Ensure Data is Available When and Where NeededCollaboration Features

In addition to the web based access which enables document / file sharing:

• Users can check files out of the system

• Other users can still view files, but may not edit

• This prevents inadvertent overwriting of changes when 2 users are working on the same document

• When editing is complete, the new version of the file is checked in, releasing the file to other users


June, 2007

Develop Compound DocumentsCopy Content and Traceability Information

Build reports from a variety of source documents with the Send To feature:

• Send a selected portion of a file, or the entire file

• Elect to Send To one, many, or all open Microsoft applications

• Send graphics as scalable vector graphics for high integrity graphics with no loss in resolution

• Include a hyperlink back to the original source data stored inside the content repository


June, 2007

High Resolution Graphics for ReportsCopy Scalable Vector Graphics from PDF

Scalable vector graphic with Bluestone

Bitmap copied with Acrobat

The Bluestone plug-in for Adobe Acrobat allows copy of SVG from PDF

• PDF is a rich, complex file format• When scalable vector graphics are

present when the PDF is generated, that graphic is preserved within the PDF file

• Acrobat’s Copy tool does not take advantage of this high resolution graphic content

• Bluestone allows the copy of SVG graphics from this information rich file format - PDF


June, 2007

Move Data to Offline StorageLong Term Archive

When data is no longer frequently accessed, it can be moved to offline storage• The data transfer process can be

automated based on user defined time schedules

• Even when files are stored on offline media, a user with appropriate privilege can search and find the data

• When an archived volume is mounted, the file is completely accessible to users with no complex restore procedure

• When a user attempts to interact with a file stored on media that is offline, they are notified that the file is not available and asked if they’d like to request that the volume be remounted


June, 2007

Complete your Electronic Records Life CycleAutomate Record Retention Policies

With the record retention features, the final step in a file’s lifecycle can be automated

• A retention class is defined with an expiration policy and a disposition for the file when it expires

• When the expiration date is reached, the file is routed through a review process

• If the disposition is approved, the file is either removed permanently from the system, or reassigned to another retention class

• If the disposition is rejected, the file is sent to executive review


June, 2007

OpenLAB ECM ArchitectureWorkgroup Solution


June, 2007

OpenLAB ECM ArchitectureEnterprise Solution


June, 2007

Summary

Agilent’s OpenLAB ECM system can provide…

• Secure centralized data management

• Minimum impact to end user workflows

• Audited user access and data activity

• Data availability and easy retrieval

• Reduced approval times of paper based systems

• Data manage through the entire life cycle

…for all of the data types produced in your laboratory.