ARAISBe ready for every audit, every day.
ARAIS keeps your procedures, records and audits in one place, checks them against the standards you're audited on, and shows how ready you are right now, before any auditor walks in.
One cycle, the same one every auditor follows
The four colours of the ARAIS logo are the four steps of Plan, Do, Check, Act. ARAIS supports each step, then starts the next round with what you learned.
Know what's coming
Set up your audit types and plan every audit on a shared calendar.
- Audit register and calendar
- Reminders and calendar feeds
- Readiness score for each audit
Keep records right
Hold every procedure in one library, with versions and signatures.
- Upload by drag and drop or phone camera
- Scans read automatically
- Electronic signatures on approval
Find gaps first
Let AI compare your procedures with the rules, then practise.
- AI gap analysis with citations
- Mock audits with scored answers
- Regulator alerts matched to you
Close the loop
Turn findings into actions with owners and due dates.
- Findings with risk ratings
- Observations and CAPA
- Word and Excel reports
Everything your team needs before, during and after an audit
ARAIS uses your industry's own words. Pick your industry and the standards you're audited against, and the screens, examples and audit types follow.
Procedure library
Every SOP and policy with its full version history, department permissions and signed approvals. Combine several libraries into one view.
AI gap analysis
Compares a procedure with the regulation or standard, and lists each gap with the exact clause it came from and a risk rating.
Ask ARAIS
Ask questions about your own procedures and the rules in plain language. Every answer points to its source.
Mock audits
Practise with inspector-style questions from a regulator, certification body or customer, and get scored feedback on each answer.
Readiness dashboard
A live score for the whole organisation and for each department and audit, plus what needs whose attention today.
Audit calendar
Month, week and list views, clash warnings, reminders and preparation checklists, with feeds for Outlook and Google Calendar.
Regulator watch
A weekly check of new FDA Warning Letters, matched to your own procedures, for industries the FDA regulates.
Reports
Standard Word and Excel reports of approved findings, ready to share with management or the auditor.
Works on your phone
A mobile-first app you can add to your home screen. Photograph a paper record and ARAIS reads the text for you.
Coming next: email and push alerts, filling in your own report templates, a yearly audit programme, and FDA Form 483 data.
AI that shows its work, and a person who signs it off
In a regulated business, an answer you can't trace back to a source is a risk. ARAIS is built so every AI result can be checked.
- Every finding cites its clauseA citation checker confirms the quoted rule really exists before you see it.
- People stay in chargeAI suggests; a qualified reviewer accepts or rejects each finding, and that decision is recorded.
- Tested before it's trustedQuality is measured against a test set your QA team approves, and every AI run is kept on record.
- You control itAI is off until an administrator switches it on, with a monthly spending limit you set.
Built to stand up in front of an auditor itself
ARAIS follows the record-keeping and privacy rules it helps you meet: 21 CFR Part 11, EU GMP Annex 11 and the ALCOA++ principles for trustworthy data, with privacy controls that support GDPR, HIPAA and India's DPDP Act.
Tamper-evident audit trail
Every change records who, what, when, the old and new value, and why. Each entry is linked to the one before, so any later edit breaks the chain and is caught by a daily check.
#1041 3fa9…→#1042 c27e…→#1043 81d0…Electronic signatures
Signing asks for the meaning of the signature and a password or second-factor check, and is tied to the exact content signed.
Your data stays yours
Each organisation's data is separated inside the database itself, so one customer can never see another's, even by mistake.
Company sign-in
Sign in with Microsoft, with multi-factor sign-in, passkeys and lockout after failed attempts. Seven ready-made roles decide who can do what.
Safe uploads
Every uploaded file is scanned for malware, and approved originals are stored so they can't be overwritten.
Hosted on Microsoft Azure
Runs on Microsoft's cloud, which is independently certified to ISO/IEC 27001 and audited for SOC 2, with secrets kept in Azure Key Vault and automated checks on every software change.
Personal data kept out
Uploads that look like patient or personal data, such as dates of birth, patient numbers or national ID numbers, are blocked before they are stored or sent to AI.
Recording only with consent
Audit meetings are recorded only when everyone present has agreed. Recordings are encrypted, kept only as long as you set, then erased automatically.
Encrypted end to end
Data is encrypted in transit and at rest. Recordings and the AI keys you add are encrypted again with AES-256, with the key held outside the database.
Rules ARAIS is built to support
ARAIS gives you the controls these rules ask for, such as audit trails, signatures, consent, retention limits and access control. Compliance and certification belong to your organisation; ARAIS helps you show the evidence.
Standards you can prepare for
Choose the standards you're audited against, and ARAIS uses their language, examples and audit types. About 70 are built in, including:
Blogs, articles and videos
Practical ideas for staying audit-ready, from the ARAIS team.
See ARAIS with your own procedures
Tell us a little about your organisation. We'll show you ARAIS set up for your industry and the standards you're audited on.
rajendra.sadare@gmail.com