The Cost of Validation
Initial Analysis $100,000
Development and Execution $500,000
It is amazing, a client pays 100K to 2M or more to develop a system and $0 to make sure the system works. How do we ensure the system meets our needs?
Solution Assessment and Validation
Solution Assessment and Validation is one of six knowledge areas defined in the BABOK (Business Analysis Book of Knowledge). I recently helped a government client document and execute validation under FDA 21 CFR Part 11 rules.
FDA 21 CFR Part 11 Computer Systems Validation outlines validation methods to ensure the system works as expected and meets the business need. All systems must have a Validation Plan, User Requirements, Functional Requirements, and Test Scripts.
User Requirements are general requirements concerning the use of a system.
Functional Requirements break down User Requirements into how users will specifically interact with the chosen system.
Test Scripts are written for each Functional Requirement.
Test scripts are executed, witnessed, and counter-signed. After execution the organization has a fully documented and auditable trail to show the system was properly installed and qualified to meet the business need and technical requirements.
In addition, a validated client documents Standard Operating Procedures for use of the system. This step forces the organization to take a close look at how the system will be used and why it is being implemented. Any time people spend to think through how and why they use a system is a good thing!
The downside is less flexibility in making system changes. A COTS system that is highly configurable and easily changed is now subject to a multi-level change control process. A simple configuration change may take days or weeks to propose, authorize, document, and implement.
21 CFR Part 11 Validation is worthwhile where the cost of deviation from process greatly exceeds the cost of change. In the case of manufacturing pharmaceutical drugs or vaccines, minor deviations in process can impact the lives of millions of people with drastic consequences. It’s in these very cases that validation is indeed worthwhile to ensure systems meet the safety and security concerns of all.
Jonathan Malkin is a Business Analyst at Plateau Systems. Jonathan provides configuration, integration, documentation, and deployment support services for a leader in Talent Management Systems. Jonathan’s areas of support include 21 CFR Part 11 Validation and customizations to COTS software for which he has won multiple awards. His experience includes work in the federal government, telecommunications, mortgage and banking, and custom software development industries. Plateau Systems is a leading global provider of adaptable, unified web-based talent management software, content and services to onboard, develop, manage and reward talent.