A1 Audit App

A1 Audit helps auditors prepare, perform, document, and export structured GxP audit records on their own device. The app supports audit planning, checklist-based execution, evidence capture, findings, notes, document references, draft reports, final reports, and local audit history. It is designed for quality, compliance, supplier, pharmacy, manufacturing, distribution, and food-safety audit workflows where traceability and consistency matter. A1 Audit is not a government app and does not represent any government entity, regulator, authority, ministry, agency, or public body. A1 Audit is an independent audit documentation tool. Regulatory, professional, or public-source references are provided only as source-labelled checklist and reference material for professional audit preparation. Users must verify applicable requirements against the current official source. A1 Audit stores audit content locally on the user’s device unless the user chooses to export or share files. The app is not a medical, diagnostic, financial, banking, insurance, crypto, lending, or investment app. Free users can create one unique audit ID per year. Yearly plans unlock additional audit creation limits. Official sources for referenced public regulatory or professional information include: EU GMP Volume 4, including Part I, Part II and GMP Annexes: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en EU GDP Guidelines: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52013XC1123%2801%29 FDA Current Good Manufacturing Practice regulations, including 21 CFR Parts 210 and 211: https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations Brazil ANVISA GMP regulations, including RDC 658/2022: https://www.gov.br/anvisa/en/regulation-of-companies Japan PMDA GMP, QMS and GCTP inspection information: https://www.pmda.go.jp/english/review-services/gmp-qms-gctp/0001.html Codex Alimentarius General Principles of Food Hygiene, CXC 1-1969: https://www.fao.org/4/cc6125en/cc6125en.pdf EU Regulation 852/2004 on food hygiene: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32004R0852 KNMP pharmacy guidelines, including Practice Management, Preparation, Dispensing, Medication Surveillance and Individualised Dispensing Forms: https://www.knmp.nl/richtlijnen/samenvattingen-knmp-richtlijnen KNMP Practice Management guideline: https://www.knmp.nl/richtlijnen/praktijkvoering KNMP Preparation guideline: https://www.knmp.nl/richtlijnen/bereiden KNMP Dispensing guideline: https://www.knmp.nl/richtlijnen/ter-hand-stellen KNMP Medication Surveillance guideline: https://www.knmp.nl/richtlijnen/medicatiebewaking KNMP Individualised Dispensing Form guideline: https://www.knmp.nl/richtlijnen/geindividualiseerde-distributievorm-gdv KNMP Automated Medicine Distribution System standard, GDS: https://www.knmp.nl/richtlijnen/geautomatiseerd-geneesmiddelendistributiesysteem-gds IGJ information on GDS pharmacies and the KNMP GDS standard: https://www.igj.nl/zorgsectoren/eerstelijnszorg/apotheken/grensapotheken-en-gds-apotheken NVZA GMP-Z guideline for Dutch hospital pharmacy preparation: https://nvza.nl/gmp-z-richtlijn/ Dutch Government notice on GMP-Z guideline changes: https://zoek.officielebekendmakingen.nl/stcrt-2026-1775.html