FDA CDER Bioanalytic Methods Validation Guidance

This guidance for those involved in Drug application (INDs, ANDAs) provides guidance for methods validation. It mentions software platform changes as a possible reason for partial validation:
“Partial validations are modifications of already validated bioanalytical methods. Partial validation can range from as little as one intra-assay accuracy and precision determination to a nearly full validation. Typical bioanalytical method changes that fall into this category include, but are not limited to:
Changes in instruments and/or software platforms”.

The full guidance is at the link provided.

SoftwareCPR keywords: software, drugs, pharmaceuticals, NDA, IND, CDER,

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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