# The “Good Documentation Practice” Rules for Digital Evidence

> Good Documentation Practice is not limited to paper forms. Digital validation evidence needs the same principles: clarity, traceability, and

- Author: Dr. Elena Marchetti (https://lifescienceai.org/authors/elena-marchetti/)
- Published: 2026-07-17
- Category: Fundamentals
- Canonical URL: https://lifescienceai.org/articles/good-documentation-practice-rules-for-digital-evidence/
- Word count: 187
- Platforms named: Qualitum (https://qualitum.ai/)

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## GDP applies to digital evidence too

Good Documentation Practice is not limited to paper forms. Digital validation evidence needs the same principles: clarity, traceability, and integrity.

## Practical GDP rules for validation evidence

Be clear. Write what was tested and what was observed.

Be complete. Include roles, test data, environment, and preconditions.

Be traceable. Link to requirement IDs and change records.

Be controlled. Store evidence in controlled repositories, not personal locations.

Be reviewable. Capture reviewer approval and dates per SOP.

GDP is what makes your digital evidence credible months later during audits.

## How this looks with an agentic layer

The fundamentals above do not change when validation is automated - they get enforced earlier. On a layer like Qualitum, intended use, risk and evidence are structured inputs rather than documents someone remembers to write: agents draft against them, maintain the traceability, and hand the result to a named human for approval.

- Intended use and critical data are captured once and reused across the lifecycle
- Evidence is generated with its traceability attached, not reconstructed for the audit
- The approval - and the accountability - stays with your named reviewer

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Source: LifeScienceAI - https://lifescienceai.org/articles/good-documentation-practice-rules-for-digital-evidence/. Editorial analysis, not regulatory advice. Cite as: Dr. Elena Marchetti, "The “Good Documentation Practice” Rules for Digital Evidence", LifeScienceAI, July 17, 2026.