gxp-validator

gxp-validator is an agent for coding agents from pjt222/agent-almanac. It costs 53 tokens per session (1,904 once invoked), scanned A, original, MIT.

A guide to validating computer systems used in regulated industries such as medicines, clinical research, and laboratory work. It covers rules including 21 CFR Part 11, EU Annex 11, and GAMP 5, which govern electronic records, signatures, and software validation.

In plain words
What is it for?
Use it to plan validation, assess software risk, write user requirements and procedures, create testing protocols, maintain traceability, manage changes, monitor data integrity, and decommission systems.
Why use it?
It helps teams turn regulatory requirements into documented system checks and controls throughout a system’s life. This reduces uncertainty around approvals, changes, data integrity, training, and retirement.

Agent

Part of the agent-almanac plugin — 122 skills, 76 agents shipped together

Install

Getting it into your agent

One page per mod, every tool's command on it. A separate URL per tool would split the same page into five that compete with each other.

agentmods
npx agentmods add agents/pjt222/agent-almanac/gxp-validator
Clone the repo
git clone --depth 1 https://github.com/pjt222/agent-almanac

Or install agent-almanac, the plugin that ships this one along with the rest of its 122 skills, 76 agents.

Wrote this? Show the measurements

A badge with what this costs and how it scanned, read live from this page, so it follows the numbers instead of freezing them. Markdown for a README, HTML for a documentation site or a project page.

agentmods badge for gxp-validator

README.md
[![agentmods](https://agentmods.dev/badge/agents/pjt222/agent-almanac/gxp-validator.svg)](https://agentmods.dev/agents/pjt222/agent-almanac/gxp-validator)
Your own site
<a href="https://agentmods.dev/agents/pjt222/agent-almanac/gxp-validator"><img src="https://agentmods.dev/badge/agents/pjt222/agent-almanac/gxp-validator.svg" alt="Measured on agentmods" height="20"></a>
Per session 53 Only the description is in the session, so the agent can decide to use it. The body loads when it is invoked.
When invoked 1,904 The whole file, excluding the scripts and references it only reads on demand.
Security scan A 0 findings. Scan, not verified.
Origin original No closer match found in the catalogue.
Token cost

What it costs to keep this loaded

Counted locally with the o200k_base tokenizer, which is exact for GPT models; Claude uses its own tokenizer and its counts differ. Treat this as one consistent yardstick across the catalogue rather than a bill. Prices are per million input tokens.

ModelPer sessionOnce invoked
Fable 5 $0.00053 $0.01904
Opus 5 $0.00026 $0.00952
Sonnet 5 $0.00011 $0.00381
Haiku 4.5 $0.00005 $0.00190

Measured 5d ago against content hash 66dab3a40fcc, method: parsed. Prices are Anthropic first-party input rates as of 2026-08-30, from the pricing page.

Security

Grade A, and why

gxp-validator scanned grade A with 0 findings against 26 rules in 11 categories — prompt injection, anti-refusal, data exfiltration, privilege escalation, supply chain, agent snooping, system-prompt leakage, SSRF and excessive agency — measured 5d ago.

A static scan of the body, not an audit. Every finding is printed with the line that produced it so you can judge whether it matters here. A mod is markdown that instructs an agent; that is exactly why what it instructs is worth reading.

Nothing flagged

None of the 26 patterns this scan looks for appear in this file: no shell pipes, no recursive deletes, no credential paths, no hidden text, no instruction-override or anti-refusal phrasing, no agent-config snooping. That is not a guarantee, it is the absence of the things that are checkable.

agents/gxp-validator.md · 158 lines

How it starts

The opening of the file, as written. The whole thing — 158 lines — stays where its author put it; the contents beside it link to each section on GitHub.

GxP Validator Agent

A Computer Systems Validation and regulatory compliance lifecycle specialist that guides organisations from initial compliance architecture through validation, operational sustainment, and system decommissioning.

Purpose

This agent assists with the full regulatory compliance lifecycle for computerized systems in GxP-regulated environments. It covers compliance architecture design, Computer Systems Validation (CSV) per GAMP 5, electronic signature implementation, change control, SOP development, data integrity monitoring, training programme design, and system decommissioning — all in compliance with 21 CFR Part 11, EU Annex 11, and applicable GxP regulations (GMP, GLP, GCP).

Capabilities

  • Compliance Architecture: Map regulations to systems, classify criticality, define validation strategies and governance
  • GAMP 5 Risk Assessment: Classify systems by software category (1-5) and perform risk-based validation planning
  • Validation Lifecycle: Guide URS creation, validation planning, IQ/OQ/PQ protocol development, execution, and summary reporting
  • Traceability: Build and verify Requirements Traceability Matrices (RTM) linking requirements through risk to test results
  • Electronic Signatures: Implement 21 CFR 11 Subpart C compliant signatures with manifestation, binding, and policy
  • Data Integrity: Design ALCOA+ monitoring programmes with anomaly detection and metrics dashboards
  • Change Control: Evaluate change impact on validated state, determine revalidation scope, and track through closure
  • SOPs and Training: Write GxP-compliant SOPs and design role-based training programmes with competency assessments
  • Pharma Serialisation: Guide implementation of EU FMD, DSCSA, and EPCIS-based track-and-trace systems
  • System Decommissioning: Plan controlled retirement with data retention, migration validation, and archival

Available Skills

Core skills (loaded automatically when spawned as subagent) are marked with [core].

Read the full file on GitHub · 158 lines

Changes

What this file has done since we first saw it

Hashed on every crawl. A supply-chain change to an agent config is a question of when, not whether, so the history is kept rather than the latest state alone.

  1. 5d ago First seen · 158 lines · 53 tokens per session scan A 66dab3a40fcc

Subscribe to this mod's changes

gxp-validator is an agent published in the GitHub repository pjt222/agent-almanac (32 stars, last pushed yesterday), licensed MIT. It adds 53 tokens to every session and 1,904 once invoked, about $0.0003 per session on Opus 5. A static security scan graded it A with 0 findings. No closer match exists in the catalogue, so it is treated as the original; first seen 2026-08-30.

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