1. Case Study Pharmaceutical Retail & Distribution
Leading Pharmaceutical Company Reduces Costs to Meet CFR Compliance
through Digital Signature Implementation
Client Overview
A leading international pharmacy-led health and beauty group with two core business activities, one being pharmacy-led health and beauty retailing the
other pharmaceutical wholesaling and distribution.
Hexaware Approach
A leading pharmaceutical retailer required an effective way of managing a record keeping and
audit process for their test activities that would provide compliance with Code 21 of the Federal The Challenge
Regulations (CFR) Part 11, involving sign-off at various stages within the testing process for
many projects, thousands of test assets and multiple test teams. Current approval process is labour and
paper intensive. Retention of records for
Hexaware provided its eSignature solution to assist the client by implementing a method of the required 7 years entails significant
capturing electronic signatures at appropriate points in the workflows, storing relevant physical storage to cope with the number
information and enabling an audit trail to be retrieved for each applicable asset. of records and their supporting material.
Solution Framework Value Delivered
Hexaware’s comprehensive eSignature Solution was implemented through following phases: Hexaware helped the organization
• Define formal process of approval
Planning
• Definition of current Quality Center (QC) configuration within the testing lifecycle
• Gathering information to define approval workflows for each QC module • Capture of electronic signatures
• Store all approval records in database
Preparation of Functional Specification
• Workflows defined along with state transitions for approval by client QA • Provide audit trail, with all relevant
• Review of client QC customization compliance data
• Definition of modules and projects to be covered
• Defined user approval groups
Implementation
• Installation of Admin console and API Technology Environment
• Creation of Rules and Transistions • HP QC : 10.0 (patch 16)
• Seamless integration of eSignature in client QC modules • Database Server : SQLServer 2005 SP3
• Training and knowledge transfer for administrators and users
• Version Control : QC enabled
• Customization of tool reflecting client ownership
• Modules : Requirements, Test Plan,
Test Lab, Defects
Post Implementation
• Acceptance and sign-off for Workflows, Rules and State Transitions by client
• Documented installation specification
• Training materials and eSignature documentation
© Hexaware Technologies. All rights reserved. www.hexaware.com