Validation
Skill packages tagged with “Validation”
AI Risk & Transparency Auditor
Draft and validate a Fundamental Rights Impact Assessment (FRIA) for high-risk AI systems under the EU AI Act. Validates Instructions for Use against Art. 13 transparency requirements and audits technical documentation for bias mitigation and data governance per Art. 10.
Annex 1 CCS Validator
Draft and validate a Contamination Control Strategy (CCS) for pharmaceutical sterile manufacturing per EU GMP Annex 1 (2023). Maps cleanroom classifications to grades A/B/C/D, validates environmental monitoring limits against the stricter 2023 microbial thresholds, and checks airflow patterns, pressure cascades, and CCS element coverage.
Chemical Safety (SDS Author)
Author and validate Safety Data Sheets (SDS / FISPQ) compliant with REACH Annex II, GHS, CLP Regulation, and ABNT NBR 14725-4 for EU and Brazilian markets. Validates the 16 mandatory sections and cross-checks chemical concentrations against CLP thresholds to auto-suggest H and P phrases.
CMMI-DEV Validation
Draft CMMI-DEV Validation (VAL) deliverables: validation plan and validation results for ML3.
GMP SOP & Validation Author
Guided elaboration of GMP documentation — SOPs, validation protocol (IQ/OQ/PQ), and batch record template sections aligned to FDA 21 CFR 211 / EU EudraLex Vol 4 / WHO GMP.