Archive of Electronic Data Astrix Software Technology Global Solutions Provider To The Regulated Community.

Archive of Electronic DataArchive of Electronic DataArchive of Electronic DataArchive of Electronic Data

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If Archival of Electronic Data Is To Be If Archival of Electronic Data Is To Be Effective Their Must Be A Records Effective Their Must Be A Records

Management Process In PlaceManagement Process In Place

If Archival of Electronic Data Is To Be If Archival of Electronic Data Is To Be Effective Their Must Be A Records Effective Their Must Be A Records

Management Process In PlaceManagement Process In Place

Irretrievable InformationIrretrievable Information Integrity CompromisedIntegrity Compromised Lost DataLost Data

Deficient or Non Existent ProgramDeficient or Non Existent Program

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“The Reality at the end of the 20th Century is that Most Records are

Created Electronically.

“Electronic Records are Physically and Intellectually Fragile.”

John Carlin, Chief Archivist of the US Government

“The Reality at the end of the 20th Century is that Most Records are

Created Electronically.

“Electronic Records are Physically and Intellectually Fragile.”

John Carlin, Chief Archivist of the US Government

Information Density V. Life Expectancy

The Capacity of The Medium To Store Electronic Records Have Increased By A Factor Of 2 Million

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Risk Required To Maintain Information Has Increased Substantially

Life Expectancy of the Records Have Decreased By A Factor 5,000

The Pace of Technology Change Is The Pace of Technology Change Is Rapid And Results In A Demand For Rapid And Results In A Demand For

The Archivist To Identify Data The Archivist To Identify Data Migration Strategies and Technology Migration Strategies and Technology

Maintenance Plans To Deal Effectively Maintenance Plans To Deal Effectively With The ChangeWith The Change

The Pace of Technology Change Is The Pace of Technology Change Is Rapid And Results In A Demand For Rapid And Results In A Demand For

The Archivist To Identify Data The Archivist To Identify Data Migration Strategies and Technology Migration Strategies and Technology

Maintenance Plans To Deal Effectively Maintenance Plans To Deal Effectively With The ChangeWith The Change

The Adoption of Corporations And The Adoption of Corporations And Individuals To New Technologies Is Individuals To New Technologies Is

AcceleratingAccelerating

The Adoption of Corporations And The Adoption of Corporations And Individuals To New Technologies Is Individuals To New Technologies Is

AcceleratingAccelerating

Technology Growth

Year

1873

1876

1886

1903

1906

1926

1952

1953

1975

1983

1991

0 10 20 30 40 50 60 70

Electricity

Telephone

Automobile

Airplane

Radio

Television

VCR

Microwave Oven

Personal Computer

Cellular

Internet

Years To Spread To 25% Of Population

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The Pace of Change In The Computer Industry Is

Dramatically Increasing and Is Staggering

4 Million New Computer Programs Annually

1,200 Computer Languages Updated 16 Months

Operating Systems Upgrade Every 12 Months

500 Commercial Database Updated 12 Months

ComputerWorld Statistics 2001

The Pace of Technology Change Is Rapid The Pace of Technology Change Is Rapid The ResultThe Result

High Obsolescence RateHigh Obsolescence Rate

The Pace of Technology Change Is Rapid The Pace of Technology Change Is Rapid The ResultThe Result

High Obsolescence RateHigh Obsolescence Rate

Technology ObsolescenceTechnology ObsolescenceTechnology ObsolescenceTechnology Obsolescence

Storage Medium Punch Cards 5.25” Floppy Disks

Software MS Word 6.0 Can’t Read MS Word 7.0 Files Obsolete and Proprietary Databases – Estimate 100,000’s (Gartner Group, 2001)

Hardware

Charles Babbage Charles Babbage Analytical Engine Analytical Engine

18341834

Georg Scheutz Georg Scheutz Difference Difference MachineMachine

18431843

IBMIBMUnivacUnivac19561956

IBMIBMPC 5100PC 5100

19761976

Ed RobertsEd RobertsAltair-First PCAltair-First PC

19751975

CompuPro ConvergentCromemco Dauphin DECEpson Franklin HP IBM IMSAI InterSystems Kaypro Mattel

Ampro Amstrad PPC-640Apple Apricot Atari Bally Astrocade Byte Computers California ComputerColeco ADAMCommodoreCompaq CompuColor II

MITS Morrow Micro NEC Netronics North Star HorizonPMC Processor TechRadio Shack Rockwell Sinclair ZX81Spectravideo SWTPC Texas Instruments

1976 - 19851976 - 1985

Electronic Data Storage Trends

More Data Can Be Stored On A Smaller More Data Can Be Stored On A Smaller Physical Space On A Medium That Is More Physical Space On A Medium That Is More Fragile and Has A Shorter Life ExpectancyFragile and Has A Shorter Life Expectancy

The Pace of Technology Change And The The Pace of Technology Change And The Increasing Obsolescence Rate Makes The Increasing Obsolescence Rate Makes The Archive Process More ChallengingArchive Process More Challenging

The Volume of Electronically Generated The Volume of Electronically Generated Records Now Exceeds Paper Records and Is Records Now Exceeds Paper Records and Is Increasing ExponentiallyIncreasing Exponentially

Option 1

How Do We Preserve The Integrity of Archived

Electronic Records

Go Back To Paper orPapyrus (Good For 5,000 Years)Automates The Generation Of Residue Reports

Option 2

How Do We Preserve The Integrity of Archived

Electronic Records

Print Electronic Data On Paper

Collect Electronically And Print a Hardcopy as Collect Electronically And Print a Hardcopy as

A True and Exact Duplicate or As The Raw DataA True and Exact Duplicate or As The Raw Data

Increasing Percentage Of Electronic Data Increasing Percentage Of Electronic Data

Cannot Be Printed – Database Records – Cannot Be Printed – Database Records –

Relationships - MetadataRelationships - Metadata

Cost Escalates With Need To Maintain Cost Escalates With Need To Maintain

Two System: Electronic and PaperTwo System: Electronic and Paper

Option 3

How Do We Preserve The Integrity of Archived

Electronic Records

Implement An Electronic Archive Implement An Electronic Archive Data Management ProgramData Management Program

Electronic Archive Data Electronic Archive Data Management Program ElementsManagement Program Elements

Identification Classification Rules (Creation To Disposal) Controls Prevent Corruption Retention Times QAU Monitoring

Identification - SourcesIdentification - Sources

Written and Transcribed Data Values Entered Directly Into A

Computer System Values Created Automatically By A

Computer

ClassificationClassification

Examples of electronic Records and Data That Qualify as Raw Data

Instrument data LIMS data Report Summaries Word Processing Documents Spreadsheets Email

Define Controls To Prevent Data Corruption and Unauthorized Access

Assign Retention Times To DataDefine Rules For Purchasing, Maintaining, Replacing

and Exercising Physical Storage MediaQAU Monitors Data Management Program

Define Rules of Managing Data From Define Rules of Managing Data From Creation To DisposalCreation To Disposal

Attempt To Archive Electronic Data On One Medium (i.e. CD ROM)

Storage Environment For Electronic Similar To Paper External Backup of Data Should Be Maintained Off-Site Insure You Clearly Identify The Points The Data Goes

From Active, Semi-Active to Archive

Common ElementsCommon Elements

Readability and RetrievabilityReadability and Retrievability

Unless There are Built-In Migration Paths or Newer Generations of the Software Offer Backward Compatibility To Older Versions of The Software, Access to the Records Will Be Impossible

Preventing Hardware / Software ObsolescencePreventing Hardware / Software ObsolescenceMigration Planning

Periodically Transfer Data To Maintain Compatibility In Addition To “Raw Data” The “Metadata” Must Be

Migrated If A Technology (Software System) Is Discontinued

Must Maintain the Last Installation of that System Provided That Version Has Backward Migration (Software Installation and Operating Environment)

Maintaining Software Version and Operating Maintaining Software Version and Operating EnvironmentEnvironment

Validate The Migration Process Image The Disk Using Ghost Software. Captures

An Exact Image of the Operating System and All Files Including the Software

Technologies Used To Aid The Image, Technologies Used To Aid The Image, Recovery and Data Corruption ProcessRecovery and Data Corruption Process

Disk Imaging

1. PowerQuest "Drive Image 2002" 2. Paragon "Drive Image 5.0" Enterprise Edition 3. Norton Ghost 2001

Security & Data Corruption 1. Clearswift MIMEsweeper - Product Suite2. Intego Fileguard Security Software

Disaster Recovery 1. Veritas Backup Exec 2. CA BrightStor ARCserve Disaster Recovery3. Yosemite Tech Tapeware Disaster Recovery

Management CommitmentManagement Commitment

The Stakes Are High And Management Must Be Committed To Maintaining A Program To Archive

Electronic Records

MistakesMistakes

Craven Laboratories: GLP Pesticide Testing Laboratory: 1991 Manually Manipulated Electronic Data – Lack of Adequate Archived Results Proved Falsification

Result: 20 Felony Counts, Owner Jail 5 Years, Laboratory Fined $15 Million

Conclusions

Develop A Thorough Electronic Data Archive Develop A Thorough Electronic Data Archive Program To Mitigate RiskProgram To Mitigate Risk

Diligently Manage Technology Obsolescence Diligently Manage Technology Obsolescence Through Migration PlanningThrough Migration Planning

The Risks of Poor Records Management Are The Risks of Poor Records Management Are Substantial For Companies Engaged in The Life Substantial For Companies Engaged in The Life Sciences Where Human Health Is At RiskSciences Where Human Health Is At Risk

Obtain Management CommitmentObtain Management Commitment

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