If documentation does not match reality, it defeats the entire purpose of GMP. This principle becomes extremely important when auditors investigate cases of documented but not performed in pharma operations.
In the pharma industry documentation, it is usually said that “if it is not documented, it is not done. Then, one question arises. Is it okay to document the activity without performing it?
No, it is not acceptable. The statement “If an activity is not documented, it is considered not done” does not mean the opposite is acceptable.
Documentation must always be a true and accurate record of what actually happened.
Documenting an activity that was not performed is called false documentation or data falsification. This is considered a serious GMP violation and can have severe consequences.
In the pharmaceutical industry, documentation serves two purposes:
- To prove that the activity was performed.
- To reflect the reality of the activity exactly as it occurred.
Disclaimer: This article is written purely for educational and awareness purposes. It does not suggest that pharmaceutical companies intentionally promote false documentation practices. Most organizations operate with strong GMP systems and ethical standards. This article intends to help operators, analysts, and supervisors understand how auditors evaluate documentation and why truthful, real-time recording of activities is critical.
Auditors Do Not Rely Only on Written Records
Many operators believe that neatly filled documents are enough to satisfy auditors. In reality, auditors are trained to verify whether documentation truly reflects what happened on the shop floor or in the laboratory. Documents are only the starting point of an audit, not the final proof.
Auditors continuously ask one basic question: Does this record match reality?
Physical Conditions Must Support Documentation
One of the most common audit techniques is comparing records with physical evidence. For example, equipment cleaning may be documented, but if residues, stains, or powder are still visible, auditors immediately question whether the activity was actually performed. Similarly, calibration records may exist, but instrument labels or due dates may not support them.
When physical conditions do not align with records, auditors strongly suspect documented but not performed in pharma practices.
Time and Sequence Tell the Real Story
Auditors carefully review dates, times, and activity sequences. They know how long real activities take. If records show multiple critical activities completed in an unrealistically short time, it raises doubts.
Backdated entries, overlapping tasks, or illogical sequences clearly indicate that documentation may have been completed without performing the actual work.
Raw Data and System Evidence Cannot Lie
In laboratories and computerized systems, auditors look beyond summary reports. They check raw data, audit trails, system logs, and instrument memory. If results are recorded but no supporting raw data exists, or if audit trails show manipulation, it becomes clear that the activity was not performed as documented.
Operator Interviews Reveal the Truth
Auditors often ask operators or analysts to explain how an activity was performed. These questions are usually simple and practical. If the person cannot clearly explain the steps, gives inconsistent answers, or describes a method that differs from the SOP, auditors question whether the task was actually performed.
Lack of understanding often exposes paper compliance instead of real GMP compliance.
Consistency Across Records Is Critical
Auditors never review documents in isolation. They compare batch records with environmental monitoring data, deviation reports, maintenance logs, and alarm records. If one document shows everything is normal while another indicates problems, the credibility of documentation is lost.
True GMP compliance requires consistency across all related records.
“Perfect” Documentation Is a Red Flag
Surprisingly, records that look too perfect can attract attention. No corrections, identical handwriting, repeated values, and zero deviations over long periods appear unrealistic. Real processes involve variation and occasional errors.
Auditors are trained to recognize documentation that looks artificially clean and question its authenticity.
Key Message for Operators
Documentation is not a substitute for performing the activity. It is evidence that the activity was genuinely carried out. If something is missed, delayed, or performed incorrectly, it must be recorded honestly and handled through the deviation system.
False documentation is considered far more serious than missing documentation because it destroys trust in the quality system.
Auditors identify these practices by comparing records with physical conditions, reviewing time logic, verifying raw data, interviewing operators, and checking consistency across documents. For operators, the rule is simple: perform the activity first, document it truthfully, and never use records to hide reality.
In pharma, documentation must always reflect the truth—nothing more and nothing less.
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