Regulatory Compliance

Executive Summary

A healthcare product and service company improved product quality and consistency to meet stringent regulatory requirements.

Case Background

Industry: Life sciences/healthcare manufacturing and services
Company: A unit of a Fortune 250 organization with sales of more than $10B in 75 countries

Key Challenges and Goals

The client, a large healthcare product division with global market presence, faced Food and Drug Administration (FDA) compliance challenges triggered by a significant number of Medical Device Reports and product quality issues. These issues had significant revenue and reputation implications for the business unit.

Affinity's Approach and Solutions

Affinity worked with the client's Global IT leadership to identify key initiatives for the project. Due to the sensitive and time-dependent nature of the project, we also worked closely with client business, technical and compliance executives and staff.

The client's global development and delivery platform required a comprehensive, global approach with both development of measurement baselines and a long-term solution. As a result, the engagement team began with a single Subject Matter Expert and ultimately drew on the necessary expertise and resources to lead and manage a $3.5M prospective and retrospective remediation program. The program included development of a product quality qualification and management plan, a risk measurement and management process, validatoin and testing templates, and a defined validation process.

Results

The engagement team identified 25 high-priority action items. Ten of these were resolved in less than 90 days. Quality assessments and audits found an additional eight action items which were recategorized as low risk issues. We also developed an innovative new infrastructure quality assessment tool that identifies business and technical health and risk issues.

The ultimate business impact of the work is expected to be in excess of $25M.

Project Snapshot

Project snapshot
Affinity expertise applied:
- Regulatory compliance
- Business process management
- IT/technical strategy
- Change management
- Project management
- Training services

Project duration: Six to nine months

Cost range: $250K to $500K