PREVIOUS NEXTPREVIOUS NEXT
Merging Multiple Drug Safety and Pharmacovigilance
Databases into One Global Oracle Argus Safet...
PREVIOUS NEXT
Agenda
• Summary of Situation
• Project Overview
• Review of Database Architecture
• Technical Overview
• De...
PREVIOUS NEXT
Summary of Situation
Project Overview
• A leading U.S.-based pharmaceutical company founded in the early 198...
PREVIOUS NEXT
Methods Used
Origin of Methods
• Argus installations contain an
Oracle DUMP (DMP) file that
contains a numbe...
PREVIOUS NEXT
Methods Used
Origin of Methods
• Unfortunately, the desired list maintenance (LM) tables (such as
products, ...
PREVIOUS NEXT
Methods Used
Technique Overview
PREVIOUS NEXT
Methods Used
PREVIOUS NEXT
Methods Used
Techniques Used
• Given that we interface with mostly safety business users and the fact
that t...
PREVIOUS NEXT
Methods Used
Techniques Used
• We identified the mandatory field data in the required tables and reflected
t...
PREVIOUS NEXT
Methods Used
Techniques Used
• Since all of the Argus native constraints were kept active in the database, w...
PREVIOUS NEXT
Methods Used
PREVIOUS NEXT
Methods Used
Techniques Used
• For mass loading of data,
BioPharm used the SQL*Ldr
application available fro...
PREVIOUS NEXT
Methods Used
Techniques Used
• The corresponding CRS tab was then saved into a corresponding CSV file
referr...
PREVIOUS NEXT
Methods Used
Techniques Used
• Many of the populated tables, such as LM_PRODUCTS, required a number
of decod...
PREVIOUS NEXT
Methods Used
PREVIOUS NEXT
Methods Used
Techniques Used
• SQL*Ldr can be executed through the standard MS Command line
interface on any...
PREVIOUS NEXT
Methods Used
PREVIOUS NEXT
Methods Used
Assumptions and Risks to Remember with this Methodology
• The BioPharm methods explained here d...
PREVIOUS NEXT
Methods Used
PREVIOUS NEXT
Methods Used
OQ/PQ Testing
• Once the CRS is final, BioPharm suggest documenting the user
requirements in a ...
PREVIOUS NEXT
Results
Impact on Globalization
• Saved ~39 days in
configuration
work
• Empowered the
company to reuse
the ...
PREVIOUS NEXT
Lessons Learned
Improvements for Next time
• MS Excel constraint and lookup columns were not always hidden f...
PREVIOUS NEXT
Ways to Engage…
• For those ready
• Proof of concept
• For those not quite ready
• Schedule early engagement...
PREVIOUS NEXT
Questions & Answers
2000 Alameda de las Pulgas
Suite 154
San Mateo, CA 94403-1270
www.biopharm.com
Rodney L....
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2013 OHSUG - Merging Multiple Drug Safety and Pharmacovigilance Databases into One Global Oracle Argus Safety System

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2013 OHSUG - Merging Multiple Drug Safety and Pharmacovigilance Databases into One Global Oracle Argus Safety System

  1. 1. PREVIOUS NEXTPREVIOUS NEXT Merging Multiple Drug Safety and Pharmacovigilance Databases into One Global Oracle Argus Safety System Facilitating Globalization with Automated Configuration Loading July 26, 2013 Rodney Lemery, MPH, PhD Vice President, Safety and Pharmacovigilance BioPharm Systems, Inc.
  2. 2. PREVIOUS NEXT Agenda • Summary of Situation • Project Overview • Review of Database Architecture • Technical Overview • Description of Methods Used • Origin of Methodology • Techniques Used • Results of Methods • Lessons Learned • What This Means for You
  3. 3. PREVIOUS NEXT Summary of Situation Project Overview • A leading U.S.-based pharmaceutical company founded in the early 1980s issued a RFP asking for assistance in the globalization of their current Argus Safety system • The company would be migrating three separate non-Argus safety applications into their central Argus database • To accommodate this migration, configuration of the data not currently present in the global repository needs to be entered and present before any meaningful mapping discussions could be final and executed
  4. 4. PREVIOUS NEXT Methods Used Origin of Methods • Argus installations contain an Oracle DUMP (DMP) file that contains a number of database tables pre-populated with the “standard” data that ships with the initial Argus application • BioPharm reviewed the associated LOG files to identify tables that were manipulated by the vendor
  5. 5. PREVIOUS NEXT Methods Used Origin of Methods • Unfortunately, the desired list maintenance (LM) tables (such as products, licenses, etc.) were not present in the DMP file • However, BioPharm does see the use of a DMP file as vendor precedence for the use of data manipulation language (DML) in configuration tables of the Argus database • Also, in our past Argus migration work, the required extract, transformation and loading tools included DML use in the Argus backend
  6. 6. PREVIOUS NEXT Methods Used Technique Overview
  7. 7. PREVIOUS NEXT Methods Used
  8. 8. PREVIOUS NEXT Methods Used Techniques Used • Given that we interface with mostly safety business users and the fact that this configuration methodology and work is technical in nature, we have devised a configuration requirements specifications (CRS) document to fully document the required elements of configuration • This MS Excel document is populated with the required elements necessary in full configuration table population
  9. 9. PREVIOUS NEXT Methods Used Techniques Used • We identified the mandatory field data in the required tables and reflected those fields in the CRS document • Meetings were then facilitated to discuss the information in the CRS and reach consensus to its content
  10. 10. PREVIOUS NEXT Methods Used Techniques Used • Since all of the Argus native constraints were kept active in the database, we needed to reflect that constraint logic in the Excel file to ensure minimum negative database impact • Sometimes, constraints were enforced by the Argus application and NOT the database
  11. 11. PREVIOUS NEXT Methods Used
  12. 12. PREVIOUS NEXT Methods Used Techniques Used • For mass loading of data, BioPharm used the SQL*Ldr application available from Oracle as part of an advanced SQL*Net installation • This application requires the creation of a control (CTL) file that describes what file should be uploaded into what table • This file also contains descriptions of the columns expected in the source data file and maps it to the corresponding Argus table
  13. 13. PREVIOUS NEXT Methods Used Techniques Used • The corresponding CRS tab was then saved into a corresponding CSV file referred to in the control file above
  14. 14. PREVIOUS NEXT Methods Used Techniques Used • Many of the populated tables, such as LM_PRODUCTS, required a number of decoded fields from the database (such as concentration units, formulation, etc.) prior to insertion (foreign key lookups) • While we could have placed those required IDs in the CRS directly, the volume of information would have been very challenging to manage • We opted instead to use SQL*Ldr to load the more complex data into temporary staging tables where a helper PL/SQL Package was used to “code” the required information by executing a series of lookup functions to return the required ID fields that are required to adhere to referential integrity
  15. 15. PREVIOUS NEXT Methods Used
  16. 16. PREVIOUS NEXT Methods Used Techniques Used • SQL*Ldr can be executed through the standard MS Command line interface on any windows machine • The execution command requires the control file
  17. 17. PREVIOUS NEXT Methods Used
  18. 18. PREVIOUS NEXT Methods Used Assumptions and Risks to Remember with this Methodology • The BioPharm methods explained here do NOT disable the native constraints and triggers used by the Argus database • All information loaded into the tables must comply with these native table constraints • There is a possibility that certain Argus application level triggers or constraints are being bypassed in this methodology beyond those already identified within these slides
  19. 19. PREVIOUS NEXT Methods Used
  20. 20. PREVIOUS NEXT Methods Used OQ/PQ Testing • Once the CRS is final, BioPharm suggest documenting the user requirements in a separate document referred to as a User Requirements Specification (URS) • This document should contain all of the high-level requirements for the globalization of the system including any major aspects of the system that the users are concerned over given the risks of using a database level loading of configuration
  21. 21. PREVIOUS NEXT Results Impact on Globalization • Saved ~39 days in configuration work • Empowered the company to reuse the scripting in future globalization efforts Configuration Type Configuration Item Count Estimated Manual Time Actual Load Time Saved Time Products 1789 7.5 0.008 7.492 Ingredients 1927 2 0.008 1.992 Licenses 4242 26.5 0.008 26.492 Datasheets 1178 1.2 0.008 1.192 Reporting Rules 156 1 0.008 0.992 E2B Receivers 70 0.6 0.008 0.592 E2B Senders 68 0.6 0.008 0.592 Manufacturers 57 0.1 0.008 0.092 TOTALS 9487 39.5 0.063 39.436 Table 1: Estimated Time Savings From Configuration Development Scripts (all time in days)
  22. 22. PREVIOUS NEXT Lessons Learned Improvements for Next time • MS Excel constraint and lookup columns were not always hidden from user view when reviewing this complex document and should have been • As many decisions on the data in the CRS were driven by Argus business use, importance should be placed in how the application is to be used before configuration data is uploaded • All end-users should actively participate in these decision discussions as the data will impact their entry, management and analysis of safety information • Automation of the CSV files from the MS Excel sheets
  23. 23. PREVIOUS NEXT Ways to Engage… • For those ready • Proof of concept • For those not quite ready • Schedule early engagement calls to provide guidance on similar projects • For those in the midst of a globalization • Refine your approach with guidance calls to review your approach and evaluate if BioPharm’s methods might be useful to your organization What this means for you?
  24. 24. PREVIOUS NEXT Questions & Answers 2000 Alameda de las Pulgas Suite 154 San Mateo, CA 94403-1270 www.biopharm.com Rodney L. Lemery MPH, PhD Vice Pres. Safety and PV Tel (650) 292-5310 Fax (650) 292-5301 rlemery@biopharm.com

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