1. Archive of Electronic Data Astrix Software 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. Irretrievable Information Irretrievable Information Integrity Compromised Integrity Compromised Lost Data Lost Data Deficient or Non Existent Program

4. Astrix Technology Group Global Solutions Provider To The Regulated Community The Reality at the end of the 20 th 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 20 th 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. The Capacity of The Medium To Store Electronic Records Have Increased By A Factor Of 2 Million Astrix Software Technology Global 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

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. Astrix Software 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 Result High Obsolescence Rate

13. Technology Obsolescence Storage Medium Punch Cards 5.25 Floppy Disks Software MS Word 6.0 Cant Read MS Word 7.0 Files Obsolete and Proprietary Databases – Estimate 100,000s (Gartner Group, 2001) Hardware

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

15. IBMUnivac1956

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

17. 4 4 CompuPro 4 4 Convergent 4 4 Cromemco 4 4 Dauphin 4 4 DEC 4 4 Epson 4 4 Franklin 4 4 HP 4 4 IBM 4 4 IMSAI 4 4 InterSystems 4 4 Kaypro 4 4 Mattel 4 4 Ampro 4 4 Amstrad PPC-640 4 4 Apple 4 4 Apricot 4 4 Atari 4 4 Bally Astrocade 4 4 Byte Computers 4 4 California Computer 4 4 Coleco ADAM 4 4 Commodore 4 4 Compaq 4 4 CompuColor II 4 4 MITS 4 4 Morrow Micro 4 4 NEC 4 4 Netronics 4 4 North Star Horizon 4 4 PMC 4 4 Processor Tech 4 4 Radio Shack 4 4 Rockwell 4 4 Sinclair ZX81 4 4 Spectravideo 4 4 SWTPC 4 4 Texas Instruments 1976 - 1985

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

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

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

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

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

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

24. Implement An Electronic Archive Data Management Program

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

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

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

28. 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

29. 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

30. 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

31. Preventing Hardware / Software Obsolescence Migration 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)

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

33. Technologies Used To Aid The Image, Recovery 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 Suite 2. Intego Fileguard Security Software Disaster Recovery 1.Veritas Backup Exec 2.CA BrightStor ARCserve Disaster Recovery 3.Yosemite Tech Tapeware Disaster Recovery

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

35. Mistakes 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

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

37. Astrix Software Technology Global Solutions Provider To The Regulated Community