Regulatory Services

Part 11 Assessments

The FDA’s requirements for computer system security and data integrity are spelled out in 21 CFR Part 11, but understanding & implementing these requirements can be challenging. Doing too little can result in an FDA finding and costly remediation. Doing too much is expensive and a waste of resources.

However, the FDA now endorses a risk-based approach to computer system validation that allows the level of validation for each function to be established in accordance with the level of potential harm resulting from a failure. QSP can help you assess your validation program requirements through expert gap assessments that objectively consider your unique situation.

We help small companies prepare for managed growth and large companies maintain compliance across the operational enterprise. Our experts are experienced with Part 11 requirements and mitigations