Need
A rapidly-growing medical device manufacturer asked Dashe & Thomson to help it comply with FDA regulations regarding software validation. The company had one ERP system and numerous clinical databases, which all needed to be validated according to guidance published by the FDA.

Solution
Dashe & Thomson helped the manufacturer put in a company-specific validation methodology so it could validate all current and future software systems according to a consistent, uncomplicated approach.

We worked with a cross-functional team to develop company policies, specific procedures, and templates to help in the validation process. Deliverables included:

• Software validation policy
• Software change control procedure
• Risk assessment procedure and template
• Validation plan procedure and template, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Templates for requirements documentation, test scripts, traceability matrix
• 21 CFR Part 11 assessment and compliance procedure
• Validation letter of certification

Dashe & Thomson’s unique approach to validation helped the company accomplish multiple business objectives through the validation effort. For example, process requirements and descriptions, essential validation deliverables, were written so the company could use the documentation as a job training aids, similar to work instructions.

Result
The team validated the entire ERP system, six clinical databases, set up all validation policies and procedures, and trained employees on the new methodology, in less than four months. In the month following the validations, the company passed an audit where software validation was a key area of scrutiny. The auditor commended the company for its logical, practical, and effective validation approach.