Challenges in Computer Software Validation

 

Data Integrity App

Challenges in Computer Software Validation:
Encouraging investment in technology is a priority for the FDA as it acknowledges digital transformation as a catalyst for reducing quality issues and patient risk.
 
Conversely, the agency’s Case for Quality initiative to identify the practices of high performers in the medical device industry, identified software validation as a leading roadblock to technology adoption.
 
Unfortunately, the industry misinterpreted 21 CFR Part 820.75 process validation and applied those requirements to software used in a life science company.
 
Manufacturers in turn subjected all software used in their processes—from software as a medical device (SaMD) to document management software—to extensive validation testing.
 
The unintended consequence was steep computer software validation implementation and change management costs. The prohibitive costs often meant life sciences companies avoided technology investments altogether—the exact opposite of what the FDA is trying to promote.


“Trust but Verify “ Ronald Reagan

 

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