Compliance

Built for regulated maintenance

Last updated 15 June 2026

Vadom is designed around how food and pharma sites are actually inspected. This page explains which standards we are built for and exactly how the system supports each one.

A note on language. Standards like 21 CFR Part 11, EU GMP Annex 11 and BRCGS are not certifications a software vendor can hold. Compliance is a shared responsibility: Vadom provides the technical controls, and your site validates the system and adopts the procedures around it. We provide a validation support pack to help.

FDA 21 CFR Part 11 and EU GMP Annex 11

These cover electronic records and electronic signatures in regulated manufacturing. Vadom supports the core technical requirements:

Requirement	How Vadom supports it
Attributable records	Every action is tied to a named, authenticated user.
Audit trail	Append-only log of every significant action, timestamped and never edited or deleted.
Electronic signatures	Captured e-signature plus named sign-off at breakdown closure.
Access controls	Role-based permissions enforced on the server for each action.
Record retention	Records are retained and exportable as PDF for the quality file.
Data integrity	Records follow ALCOA principles: attributable, legible, contemporaneous, original and accurate.

BRCGS (food safety)

Vadom is built around the maintenance expectations a BRCGS audit looks for:

Documented maintenance with a planned schedule and visibility of overdue work.
Temporary repair control, flagged with a required permanent-fix deadline so nothing is quietly forgotten.
Post-maintenance hygiene clearance, a mandatory checklist (tools accounted for, area clean, no foreign bodies, guards refitted) before a line restarts.
Traceable evidence, a timestamped, attributable record of what happened and who signed it off.

GDPR

Vadom is hosted in the EU (Dublin), keeps personal data within the EU, and supports data subject rights. Full detail is in our Privacy Policy, and a Data Processing Agreement is available to customers on request.

Validation support

For regulated customers, we provide a validation support pack covering a Part 11 / Annex 11 feature assessment, the audit-trail specification, and installation and operational qualification templates (IQ / OQ). Email hello@vadom.ie to request it.

Vadom gives you the controls and the evidence. Formal computer system validation and the standard operating procedures around use remain the responsibility of your site's quality function. We are here to make that as straightforward as possible.