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.

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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

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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

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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

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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

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Methods Used
Technique Overview

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Methods Used

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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

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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

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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

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Methods Used

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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
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Methods Used
Techniques Used

The corresponding CRS tab was then saved into a corresponding CSV file referred to in the control file above

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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

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Methods Used

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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

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Methods Used

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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

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Methods Used

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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

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Results
Impact on Globalization
Table 1: Estimated Time Savings From Configuration Development Scripts (all time in days)
Configuration Type Products Ingredients Licenses Datasheets Reporting Rules E2B Receivers E2B Senders Manufacturers TOTALS Configuration Item Count 1789 1927 4242 1178 156 70 68 57 9487

Estimated Actual Saved Manual Load Time Time Time 7.5 0.008 7.492 2 0.008 1.992 26.5 0.008 26.492 1.2 0.008 1.192 1 0.008 0.992 0.6 0.008 0.592 0.6 0.008 0.592 0.1 0.008 0.092 39.5 0.063 39.436

Saved ~39 days in configuration work Empowered the company to reuse the scripting in future globalization efforts

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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

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What this means for you?

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 BioPharms methods might be useful to your organization

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Questions & Answers

Rodney L. Lemery MPH, PhD Vice Pres. Safety and PV

2000 Alameda de las Pulgas Suite 154 San Mateo, CA 94403-1270 www.biopharm.com Tel (650) 292-5310 Fax (650) 292-5301 rlemery@biopharm.com

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