In today’s Pharmaceutical and Medical device environment, computer systems are the backbone of operations managing everything from batch records to laboratory data to quality documentation. But when these systems are not validated, the consequences can escalate quickly.
Recently, a mid-size Biotechnology company faced an unexpected FDA inspection triggered by product quality complaints. During the inspection, the agency discovered that the company’s electronic batch record system had never been properly validated despite recent upgrades.
What happened next is a scenario every quality leader hopes to avoid:
🔍 The Real Issue
The system was auto-populating critical process parameters, but due to incorrect configuration after a software update, several values were inaccurate. Operators did not detect the issue because the system displayed the information as “approved.”
This led to:
- Incorrect batch disposition decisions
- Inconsistent data integrity controls
- Inability to reproduce data during the inspection
- A Form 483 observation citing lack of control over validated systems
The company faced production delays, extensive remediation costs, and reputational impact that could have been avoided with a robust Computer System Validation (CSV) program.
Why This Happens More Often Than You Think
Organizations frequently run into CSV issues because:
- System upgrades are implemented without revalidation
- Validation documentation is incomplete or outdated
- Vendor-supplied testing is assumed to be “good enough”
- User access and audit trails are not periodically reviewed
- Change controls do not consider downstream system impact
And during an FDA or EU inspection, these gaps become visible instantly.
The Question Every Quality Leader Should Ask
“If FDA walked in tomorrow, could we confidently defend the validation state of every GxP-relevant system?”
If the answer is anything but a confident yes, your organization may be exposed.
How BioBoston Consulting Helps
BioBoston Consulting supports organizations across the life sciences sector to build and maintain inspection-ready, compliant CSV programs aligned with the latest expectations, including 21 CFR Part 11, Annex 11, and GAMP 5.
Our team helps by:
- Assessing gaps in your current CSV framework
- Validating new systems and revalidating updated systems
- Creating risk-based validation strategies that reduce unnecessary testing
Ready to Ensure Your Systems Are FDA-Compliant and Audit-Ready?
BioBoston Consulting provides expert FDA compliant CSV services, internal audits, and regulatory support for life sciences companies.
Contact BioBoston Consulting today for a CSV Audit & Validation Assessment to ensure your systems are compliant, validated, and inspection ready.