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Archive of Electronic Data. Astrix Software Technology Global Solutions Provider To The Regulated Community. If Archival of Electronic Data Is To Be Effective Their Must Be A Records Management Process In Place. Deficient or Non Existent Program. Irretrievable Information - PowerPoint PPT Presentation
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Archive of Electronic DataArchive of Electronic DataArchive of Electronic DataArchive of Electronic Data
Astrix Software TechnologyGlobal Solutions Provider To The Regulated Community
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
Astrix Technology GroupGlobal Solutions Provider To The Regulated Community
“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
Astrix Software TechnologyGlobal Solutions Provider To The Regulated Community
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
Astrix Software TechnologyGlobal Solutions Provider To The Regulated Community
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
Astrix Software TechnologyGlobal Solutions Provider To The Regulated Community
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