Data Management System

The Challenge

A Midwestern pharmaceutical company planned to add a data management system with archiving, retrieving, and reporting capabilities that managed facility data.

The Solution

Validation Planning- Pefrormance Validation (PV) developed the Validation Plan and User Requirement Specification for the data management system.  A risk assessment was performed to evaluate the impact and determine the testing requirements for the new data management system.

Commissioning and Qualification- The commissioning plan was developed by evaluating the software package in the offline environment.  Successful testing performed during execution of the approved commissioning protocol was leveraged to reduce duplication of effort when testing the data management system in the production environment.  The protocols included a traceability matrix to ensure that all user and functional requirements were met.

The Results

The new data management system successfully demonstrated the ability to archive, retrieve, and report data while maintaining compliance with electronic record requirements of 21 CFR Part 11 for audit trail and security.  Performance Validation completed the project on time and within budget for the customer allowing use of over 75 validated report templates for easier data retrieval.

The Benefits

The new data management system increased reporting efficiency by allowing multiple departments to access and retrieve secure data.  Additionally, the reporting system contained over 75 validated report templates allowing the end-user to specify the desired report.

For additional information, contact:
Brad Henry
Vice President  & Division Director, Indiana
Performance Validation, LLC.
5420 W Southern Ave, Suite 100
Indianapolis, Indiana 46241