A global medical technology company with over 8,000 employees sought to customize its validation process to comply with FDA regulations. Consultants analyzed the company's paper approval flows, designed electronic workflows for HP Quality Center, and implemented an eSignature solution. This standardized testing and quality approval processes in a consistent, repeatable manner in HP QC. It reduced costs and time by migrating pen-and-paper approvals to an electronic validation process using HP QC and eSignature. End users received training to properly use the new tools.

1. Case Study Healthcare & Life Sciences
Leading Global Medical Technology Company benefited through Electronic Validation Process
Client Overview
A global medical technology company that develops, manufactures and sells medical supplies, devices, laboratory instruments, antibodies, reagents and
diagnostic products.
Headquarters: New Jersey
Industry: Healthcare Objectives
Products/Services: Medical Services
Employees: > 8,000 Provide consulting to customize
Duration: 4 weeks validation process to support FDA
Solutions/Products: 21CFR Part 11 guidelines for
HP Quality Center 9.2 compliance
eSignature for HPQC 9.2 Implement the eSignature for HP Quality
Center 9.2 solution
Approach Provide training to end-users
Consulting Support to QA team to analyze existing paper approval flow
Design the electronic interpretation of the approval flow for HP Quality Center Results
Implement eSignature Solution to migrate pen/paper workflow to electronic equivalent Standardized testing and quality
approval processes by providing
consistent and repeatable workflows and
alerts in HP QC
Reduced cost/time associated with
pen/paper approval through the use of
HP QC and eSignature to perform an
auditable electronic validation process
Provided end-user training to ensure
proper use of tools
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