Falsification vs Error
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The regulatory distinction between an honest, unintentional mistake in a GxP record — an error, correctable under good documentation practice — and a deliberate act to misrepresent, alter, omit, or fabricate data, known as falsification, which is treated as a data integrity breach with materially more serious regulatory and, in some jurisdictions, criminal consequences.
Not every incorrect entry is falsification. An operator who transposes two digits, misreads a scale, or forgets to initial a step has made an error — a normal, expected human failure that good documentation practice handles through a visible, dated, explained correction, not concealment.
Falsification is different in kind, not just degree: it is an intentional act — backdating an entry, copying a passing result onto a different sample, deleting an unfavourable injection, pre-signing blank forms — done to make a record appear compliant when the underlying activity either did not happen as recorded or did not happen at all.
The investigation response to the two differs accordingly. An error typically triggers root cause analysis and a CAPA aimed at the system or training gap that allowed it. Suspected falsification triggers a for-cause data integrity investigation, assessment of the scope and impact across other records the same individual or process touched, and, where confirmed, disciplinary and often reportable regulatory action.
- —Error is unintentional and correctable under good documentation practice, with the change visible and explained
- —Falsification is a deliberate act to misrepresent what actually happened
- —The two trigger different investigation paths — routine CAPA versus a for-cause data integrity investigation
- —Confirmed falsification typically carries far more serious regulatory and legal consequences than an error
FDA Data Integrity and Compliance With Drug CGMP Guidance for Industry (2018); MHRA GXP Data Integrity Guidance (2018)
Frequently asked questions
What is Falsification vs Error?
The regulatory distinction between an honest, unintentional mistake in a GxP record — an error, correctable under good documentation practice — and a deliberate act to misrepresent, alter, omit, or fabricate data, known as falsification, which is treated as a data integrity breach with materially more serious regulatory and, in some jurisdictions, criminal consequences.
Which regulations cover Falsification vs Error?
FDA Data Integrity and Compliance With Drug CGMP Guidance for Industry (2018); MHRA GXP Data Integrity Guidance (2018)