1. Process and Challenges for
Upgrading OC, RDC and TMS
Oracle Health Science User
Group Conference -
November 06, 2012
Suzanne Rife
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2. Introduction
• Overview of Process for upgrading
• Testing Requirements
• Timeline
• Training
• Known bugs found during upgrade
• Issues during upgrades
• Resolutions
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3. High Level Overview of Upgrade Process – Phase I
• Export current Production DB to a staging area
• Upgrade OC RDBMS to 9.2.0.8
• Install New Windows Server – 11.2.0.3
• Install a new OC and TMS 4.6.2 Server
• Create a new OC 11.2.0.3 shell DB
• Install 2 new OC and TMS middle-tier servers
• Install 2 new RDC middle-tier servers
• Export the upgraded DB
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4. High Level Overview of Upgrade Process – Phase I (cont.)
• Import to New Server
• Upgrade 11.2.0.3 server to OC/RDC/TMS 4.6.2
• Apply OC/TMS Patchsets to 4.6.6
• Dry-run Row count verification scripts
• Execute Smoke Test for OC, RDC, TMS 4.6.6
• See Diagram
System is ready for Validation Testing
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5. Phase 1 – Validation Execution
• Due to Technology Stack Changes we recommend that full
validation packages are executed for all three Applications
• Full Validation Suite for Oracle Clinical – Modules can be
by-passed if you don’t use this module. Ex. Mass Changes
• Full Validation Suite for Thesaurus Management System –
Modules can be by-passed if you don’t use this module.
Ex. DCI
• Full Validation Suite for Remote Data Capture – Modules
can be by-passed if you don’t use this module. Ex. Classic
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6. Overview of Upgrade Process – Phase 2 Production Cut Over
• Same process as Phase 1 but completed over a “long”
weekend minus validation.
• New Installation activities completed ahead of time to
reduce Production outage time
• Close Out Validation Documentation Requirements and put
Client Production up as soon as possible
• See Diagram
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7. Timeline
• See Microsoft PP for ‘Typical’ Upgrade Project Timeline
• Timelines are dependent on the following:
– Hardware is qualified and available as expected
– Responsible Parties completing review and approval of validation
documentation
– No unexpected testing issues – SRs filed with Oracle may take time
to resolve
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8. Training
• OC Upgrade Training to 4.6.6 – 1-2 Hrs Minimal Changes
• TMS Upgrade Training to 4.6.6 – 1-2 Hrs Minimal Changes
• RDC Administration to 4.6.6 – 2 Days
– Day 1: DCI Layouts
– System Level Configuration
– Study Level Configuration
– Day 2: Study Level Configuration (continued)
– Ongoing Administration
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9. Process Re-engineering
• Review SOPs and Work Instructions (WINs) impacted by
Upgrade
• Usually related to Study Set Up for RDC Studies
– DCI Blinding
– Flexible Study Design/Enhanced DCI Book
– Conditional Branching/Blocking
• Update Study Set Up WINs with new functionality that your
company decides to utilize
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10. Examples Know Bugs found during testing – See Attached List
Priority TC Results Summary Status
Medium Fail In OC, An account which had Super User access enabled was Open
allowed to be changed from the Account Type of Oracle to Account
Type of Group. The change was saved rather than receiving the
Message box “50830: Group Accounts cannot be Super-Users.” When
this message occurred and did not display the appropriate message
box, the test step “Click [OK]” became invalid. Oracle Bug number
1391754 has been assigned to this issue.
WORKAROUND: Uncheck the “Super-Users?” box and Save the
changes.
Medium Conditional Pass In OC, Upon clicking the [Back] button after saving the Linked Patient Closed
position the system did not return to the Patient Positions for Study
TEST46OQA screen. A message box appeared with the message “Do
you want to save the changes you have made?” Buttons Yes, No and
Cancel are available. Existing Oracle Bug #3524760 found which
describes this issue.
WORKAROUND: Click [No]. The system then returns you to the
appropriate screen. The original changes were saved in Step 4, and
are not affected by clicking the No button.
Steps 5 and 7 passed on retest using the workaround.
Steps 5 and 7 PASS.
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11. Issue 1 during Upgrade
• OC/RDC/TMS 4.5.2 Upgrade to OC/RDC/TMS 4.6.4
– First Client with Windows Operating System
– Biopharm was successful with upgrading and validating version
4.6.4 on Linux Operating System
– OC crash when using character set in Discrepancy DB
• Oracle was notified of the issue and created Oracle Bug #1475897
– Validation failed for most of the Discrepancy Management Module
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12. Resolution 1
• Validation Execution was stopped. Oracle’s resolution was
to apply OC/RDC/TMS 4.6.5
• Windows Server had to be upgraded to 11.2.0.3 for this
version
• Validation was retested where it failed and passed
• Continued to complete validation execution
• Applied OC/RDC/TMS 4.6.5 for Production Cut Over
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13. Issue 2 during Upgrade
• OC/RDC/TMS 4.5.2 Upgrade to OC/RDC/TMS 4.6.5
– Active RDC Studies using PDF – Need to be converted to HTML in
order to use RDC 4.6.5 - Onsite
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14. Resolution 2
• The following must be run for each RDC Study you are
going to convert to HTML
– Verify the data entered via RDC Classic is not available in RDC
Onsite
– Run the DCI Migration job
– Verify the data has been migrated and is available in RDC Onsite
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15. Issue 3 during Upgrade
• Oracle recommends and supports IF8 Characters
• Not many clients are currently using IF8 so they must be
converted
• Conversion tested prior to applying in production, a pre-
conversion report was generated.
– Dashes or Blanks were converted and caused extra spaces
• Error: “Exceeded Column Size” means that if the row was converted it
would reject due to exceeding the column width in the table.
– Unrecognized Characters – Example French Accent Marks
• Error: “Lossy Conversion” means a row which would result in a loss of
data. IE this would be a character than given the input character set and
the output one…it cannot translate a character(s)
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16. Resolution 3
• Change the data from the front end of OC so that the data
errors won’t occur during conversion
• These changes must be made prior to your production
upgrade
• Document with Memo to file for the studies that data was
changed and why you had to change the data
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17. Conclusion
• Upgrades to applications aren’t ‘perfect’ you will likely run
into issues due to customization.
• Your upgrade can go smoother if you keep in mind some of
the issues we found during these projects
• Contact an Expert if you don’t have the qualified technical
staff to perform these upgrades
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18. THANK YOU!
Questions and Answers
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19. Contact Us
• Director of Project Management (Backup for Client
Relations):
Suzanne Rife
srife@biopharm.com
+1 734 335 7113
• General Inquiries:
info@biopharm.com
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20. Biography
• In her role as director of project management, Suzanne Rife oversees
all the project management functions at BioPharm Systems.
Exclusively in the life sciences industry, she has over ten years of
experience in clinical data management, system validation, system
process development, drug safety evaluation, and training. Suzanne
has a comprehensive understanding of clinical applications and
studies, which allows her to manage organizations' projects effectively.
Prior to joining BioPharm Systems in 2007, Suzanne held a project
management position at Pfizer.
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