Computer Systems Validation (CSV) is meant to give you confidence that a system does what it’s supposed to do, reliably and consistently. If done well, it will protect product quality, patient safety, and data integrity. If it’s done badly, it becomes a paperwork exercise that slows teams down without reducing any risk at all.
In this blog, we will discuss the most common mistakes that we see most often, and how you can avoid them.
Treating Validation as a Documentation Exercise, Not Using a Risk-Based Approach
The most common mistake in CSV is writing test scripts to satisfy a template rather than to meaningfully evidence that a system is compliant and fit for purpose.
You should therefore start every validation with a comprehensive risk assessment, letting the risk level of each function drive the depth of testing it gets. High-risk functions such as those affecting product release decisions or patient safety require rigorous testing, whereas low-risk functions don’t need the same amount of scrutiny. Employing a Risk Based approach also ensures compliance with FDA CSA guidance, EU Annex 11 and EMA ICHQ9.
Validating in Isolation from the Business Process
Systems are often validated as if they exist in a vacuum, separate from the process they support. This leads to scripts that prove the software ‘works’ but miss how it’s actually used every day.
Validation is more effective when it’s grounded in how the process actually works, and tested against real users and workflows.
Copy and Pasting Requirements and Test Scripts from Other Projects
Although it’s tempting to reuse a validation package from a similar system, the tests don’t reflect the actual configuration, interfaces, or intended use of your system, which creates false assurance and gaps that will only surface during an audit or failure.
Instead, use templates for structure and consistency, but tailor the requirements and tests to the specific system.
Weak or Missing Traceability
Without a clear line from user requirement > functional specification > test case > result, it’s difficult to demonstrate to auditors that everything that matters was actually tested.
To fix this, maintain a traceability matrix from day one. Every requirement should trace back to at least one test, and every test should trace back to a requirement.
Under-Validating Configuration and Over-Validating Out-of-the-Box Functionality
Many commercial systems such as LIMS, MES, and ERP come with vendor-tested core functionality but heavily customised configuration. Teams sometimes spend excessive effort retesting these features while barely touching the configured, business-critical parts of the system.
You should use vendor documentation, risk assessments, and audits where appropriate and focus your own testing effort on anything unique to your environment.
Insufficient User Training and Unclear Roles
Even a perfectly validated system fails in practice if the people using it don’t understand it, or if it’s unclear who owns which part of the validation cycle.
This is why clear roles and proper training are crucial for successful validation testing.
Looking for Validation Support?
Most CSV mistakes come from the same root cause: letting process replace judgement. By having a risk-based, well-documented approach to validation, it is not only more defensible than an audit, but it’s also faster and cheaper than the alternative.
If you’d like support reviewing your current validation approach or planning a new system implementation, BPV Ltd can help. Contact us today for more information.