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ValexConsulting delivers a validated system for auditing/investigating the sales force of a major Pharmaceutical Company. The system is used by a Security and Compliance department to track over 5,000 sales professionals in the field

Situation
A major Pharmaceutical Company needed a 21CFR Part 11 compliant and flexible auditing/investigational system for its sales force in order to stay compliant with PDMA (Prescription Drug Marketing Act). The system had to be integrated with existing sample distribution system, OCR (Optical Character Recognition) software as well as SFR (Sales Force Roster). Security and compliance department with over 15 employees was in need of automated solution in order to handle more audits as required by the FDA. Role-based security, audit trail, complex verification and consistency checks were programmed into the software.

Solution
3-tiered architecture was implemented utilizing: ASP VBScript, Microsoft® Visual Basic® COM and Oracle 8i. The application permits existing staff to handle a significantly higher volume of audits/investigation by increasing the productivity and decreasing the amount of paperwork.

Benefits
Over 20 users running the application that also produces notifications to the FDA in a highly structured and organized manner. Application offers flexibility in workflow as well as provides accurate up-to-date reporting for the senior management.

Fast Facts
Number of months to build the application: 12
Number of developers to build the application: 5
Number of audits: 400/month

For more information contact:
Alex Zhitomirsky
Valex Consulting, Inc.
p.215.431.7679
f.215.689.4310
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