Reference Tools

Tools

Interactive reference tools and self-audit checklists for GxP quality work. Everything on this page runs in your browser. No login, no data sent anywhere.

Audit Guides

Self-Audit Checklists

Detailed structured checklists to evaluate compliance programs, designed to find what FDA and EMA inspectors find.

DI
Data Integrity Self-Audit
5-layer DI compliance audit: infrastructure controls, system configuration, procedural controls, work practice forensics, and culture indicators. Structured around FDA, MHRA, WHO, and PIC/S DI expectations.
Advanced · Data Integrity
CSV
CSV / CSA Program Self-Audit
Evaluate your computer system validation program: system inventory, GAMP category assignments, validation documentation quality, traceability, supplier assessment, change control, and periodic review. Aligned with GAMP 5 Second Edition and FDA CSA final guidance (Feb 2026).
Advanced · CSV & CSA
EQ
Equipment Qualification Audit
Full lifecycle qualification audit for analytical instruments and manufacturing equipment: DQ, IQ, OQ, PQ, calibration, maintenance, periodic review, and change control. References USP <1058>, EU Annex 15, and ISPE C&Q Baseline Guide.
Intermediate · Equipment Qualification
QMS
QMS Self-Audit
Complete quality management system audit: document control, deviation management, CAPA quality and effectiveness, change control, training, supplier qualification, internal audits, and quality metrics. Aligned with ICH Q10 and FDA/EMA inspection expectations.
Intermediate · Quality Assurance
Reference Tools

Interactive Quick-Reference

Client-side reference tools for common GxP assessments. Nothing is sent anywhere, these run in your browser.

ALCOA+ Self-Assessment

0 / 9

Evaluate a GxP record or system against all nine ALCOA+ principles. Check each principle only if your current controls fully satisfy it.

Not assessed

GAMP 5 Category Decision Aid

Answer questions to determine the GAMP 5 software category for a system under evaluation. Based on GAMP 5 Second Edition (2022).

Is this infrastructure software (OS, middleware, database engine, network services) that is not GxP-specific?

483 Response Completeness Check

0 / 10

Before submitting a 483 response, verify each element is present and substantive. Check only items that are genuinely complete, not just drafts.

Not assessed

Validation Deliverable Selector

Select validation type to see required and recommended deliverables. Based on GAMP 5 Second Edition and FDA/EMA expectations.