Computer System Validation Program Modernization

The Challenge:

One of the top 10 largest US Medical Device companies had a corporate-wide computer system validation (CSV) program that had been developed during the days when company-sponsored custom software development projects were the norm. However, this legacy CSV methodology required over 20 deliverables for each IT project and was having a significant impact on IT deployment timelines and budgets for modern Cloud, Commercial-off-the-Shelf (COTS), and Digital Health applications.

A modernized software validation lifecycle process needed to be:

• Leaner and require fewer deliverables for less complex systems
• Fit for use with both agile and traditional software development methodologies
• Compliant with applicable FDA and global regulations
• Capable of producing safe, effective software applications

Our Solution:

Praxis led the client’s IT and QA personnel in a 4-week initiative to transform the legacy CSV program.

We designed renovated CSV program to maximize project team efficiency without compromising system quality and compliance.

Highlights of the new program include:

• A simple, streamlined Risk-Assessment process to evaluate system features for criticality (impact on patients, products, study outcomes) and likelihood of failure
• A risk-based CSV methodology to reduce the number of deliverables from 23 to 7 for a majority of IT projects.
• Risk-based development and testing practices to determine when to use quality assurance techniques, such as Design Reviews, and the appropriate degree of software testing.
• Restructured QA and IT roles to shift emphasis from reactive QC reviews of CSV deliverables to proactive, collaborative development of efficient, compliant validation approaches.

How We Did It:

Week 1

• Our validation experts facilitated a 3-day workshop to
  1. Review and assess current-state CSV procedures, roles and responsibilities
  2. Begin identifying improvement opportunities

Week 2

• We conducted targeted interviews with IT and QA process owners to collect additional information
• Our consultants prepared recommendations for changes to the current-state system risk assessment process, CSV process, and organization structure

Week 3

• We facilitated a 2-day onsite workshop with management and process owners to review the recommended:
  • Risk Assessment methodology to enable risk-based validation, development, and testing practices
  • Risk-Based Validation approach that identified the activities and documentation needed/not-needed based on Risk Assessment
  • Risk-Based Testing approach
  • Risk-Based vendor qualification approach for COTS and Cloud (SaaS, PaaS, IaaS) providers
  • Org structure, roles, and responsibilities to enable the updated practices.

Week 4

• Our team incorporated company feedback into recommendations
• We delivered a final Recommendation Report and an Implementation Plan

Praxis Can Help Your Project Succeed

Our validation experts can help you modernize your CSV program to eliminate excessive timelines and deliverables without compromising compliance and safety.