⚡AgentSkills
🧬 Biotech & Pharma · Regulatory & Clinical Data

Practice GxP-grade documentation habits

ALCOA+ principles applied daily: attributable, legible, contemporaneous, original, accurate.

intermediate~30 minBioinformaticiansLab ScientistsRegulatory Affairs

Steps

  1. 1Record observations contemporaneously; backfilling is a finding
  2. 2Sign/date entries; corrections use single-strike-through with reason
  3. 3Keep raw data untouched; analysis works on labeled copies
  4. 4Timestamps from controlled sources, not local clocks
  5. 5Audit-trail reviews scheduled per system risk tier
  6. 6Train every new team member on ALCOA+ with examples

Common Pitfalls

  • ▲Shared logins destroying attributability
  • ▲'Cleanup' edits deleting raw anomalies

Commands

Install with skills CLI
$ npx skills add aniruddhaadak80/skills --skill regulatory-clinical-gxp-documentation
Install globally
$ npx skills add aniruddhaadak80/skills --skill regulatory-clinical-gxp-documentation -g

Tags

#gxp#alcoa#documentation#biotech-pharma#regulatory-clinical

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