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Archive of Electronic Data

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

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Archive of Electronic Data

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  1. Archive of Electronic Data AstrixSoftware Technology Global Solutions Provider To The Regulated Community

  2. If Archival of Electronic Data Is To Be Effective Their Must Be A Records Management Process In Place

  3. Deficient or Non Existent Program • Irretrievable Information • Integrity Compromised • Lost Data

  4. AstrixTechnology Group Global 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

  5. Information Density V. Life Expectancy

  6. AstrixSoftware Technology Global Solutions Provider To The Regulated Community The Capacity of The Medium To Store Electronic Records Have Increased By A Factor Of 2 Million Life Expectancy of the Records Have Decreased By A Factor 5,000 Risk Required To Maintain Information Has Increased Substantially

  7. The Pace of Technology Change Is Rapid And Results In A Demand For The Archivist To Identify Data Migration Strategies and Technology Maintenance Plans To Deal Effectively With The Change

  8. The Adoption of Corporations And Individuals To New Technologies Is Accelerating

  9. Technology Growth Year 1873 1876 1886 1903 1906 1926 1952 1953 1975 1983 1991

  10. AstrixSoftware Technology Global 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

  11. The Pace of Technology Change Is Rapid The ResultHigh Obsolescence Rate

  12. Technology 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

  13. Georg Scheutz Difference Machine 1843 Charles Babbage Analytical Engine 1834

  14. IBM Univac 1956

  15. IBM PC 5100 1976 Ed Roberts Altair-First PC 1975

  16. 1976 - 1985 CompuPro Convergent Cromemco Dauphin DEC Epson Franklin HP IBM IMSAI InterSystems Kaypro Mattel MITS Morrow Micro NEC Netronics North Star Horizon PMC Processor Tech Radio Shack Rockwell Sinclair ZX81 Spectravideo SWTPC Texas Instruments Ampro Amstrad PPC-640 Apple Apricot Atari Bally Astrocade Byte Computers California Computer Coleco ADAM Commodore Compaq CompuColor II

  17. Electronic Data Storage Trends • The Volume of Electronically Generated Records Now Exceeds Paper Records and Is Increasing Exponentially • More Data Can Be Stored On A Smaller Physical Space On A Medium That Is More Fragile and Has A Shorter Life Expectancy • The Pace of Technology Change And The Increasing Obsolescence Rate Makes The Archive Process More Challenging

  18. How Do We Preserve The Integrity of Archived Electronic Records Option 1

  19. Go Back To Paper or Papyrus (Good For 5,000 Years) Automates The Generation Of Residue Reports

  20. How Do We Preserve The Integrity of Archived Electronic Records Option 2

  21. Print Electronic Data On Paper • Collect Electronically And Print a Hardcopy as A True and Exact Duplicate or As The Raw Data • Increasing Percentage Of Electronic Data Cannot Be Printed – Database Records – Relationships - Metadata • Cost Escalates With Need To Maintain Two System: Electronic and Paper

  22. How Do We Preserve The Integrity of Archived Electronic Records Option 3

  23. Implement An Electronic Archive Data Management Program

  24. Identification Classification Rules (Creation To Disposal) Controls Prevent Corruption Retention Times QAU Monitoring Electronic Archive Data Management Program Elements

  25. Written and Transcribed Data Values Entered Directly Into A Computer System Values Created Automatically By A Computer Identification - Sources

  26. Examples of electronic Records and Data That Qualify as Raw Data Instrument data LIMS data Report Summaries Word Processing Documents Spreadsheets Email Classification

  27. Define Controls To Prevent Data Corruption and Unauthorized Access Assign Retention Times To Data Define Rules For Purchasing, Maintaining, Replacing and Exercising Physical Storage Media QAU Monitors Data Management Program Define Rules of Managing Data From Creation To Disposal

  28. 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 Elements

  29. Readability 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

  30. 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) Preventing Hardware / Software Obsolescence Migration Planning

  31. Validate The Migration Process Image The Disk Using Ghost Software. Captures An Exact Image of the Operating System and All Files Including the Software Maintaining Software Version and Operating Environment

  32. 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 Suite 2. Intego Fileguard Security Software Disaster Recovery Veritas Backup Exec CA BrightStor ARCserve Disaster Recovery Yosemite Tech Tapeware Disaster Recovery Technologies Used To Aid The Image, Recovery and Data Corruption Process

  33. The Stakes Are High And Management Must Be Committed To Maintaining A Program To Archive Electronic Records Management Commitment

  34. 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 Mistakes

  35. Conclusions • The Risks of Poor Records Management Are Substantial For Companies Engaged in The Life Sciences Where Human Health Is At Risk • Develop A Thorough Electronic Data Archive Program To Mitigate Risk • Diligently Manage Technology Obsolescence Through Migration Planning • Obtain Management Commitment

  36. AstrixSoftware Technology Global Solutions Provider To The Regulated Community

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