Pharma Manufacturing — MHRA GMP

GMP compliance, continuously assured.

OLEA keeps licence holders inspection-ready across GMP, GDP and data integrity — quality-system self-assessment with grounded answers, while batch decisions stay exactly where they belong: with your QP.

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Why OLEA

Built for the people who carry compliance — not for the filing cabinet.

The PQS, continuously assessed

Chapters 1-9 evidenced as living practice — deviations, CAPA, training, validation — not a pre-inspection scramble.

Ask OLEA anything

Grounded, cited answers from GMP, GDP and the MHRA data-integrity guidance — never batch-release advice.

Data integrity you can demonstrate

ALCOA+ expectations mapped to your systems with the audit-trail evidence MHRA inspectors ask for first.

How it works

Create your organisation

Sign in with your email, name your organisation, and you're in — no sales call, no setup project.

Assess & ask

Work through the frameworks that regulate you; ask OLEA anything along the way and get cited, grounded answers.

Assure with evidence

Every answer builds your evidence base — export packs, track actions, hand off to a human advisor when judgement is needed.

Built for regulated environments

AI-assisted, human-assured — and honest about the difference.

Evidence-first AI

Answers cite only retrieved regulatory content — ungrounded references are stripped automatically before you ever see them.

You stay in control

Nothing is written to your assessment without your explicit confirmation. AI assistance is disclosed on every interaction.

Humans in the loop

An Intisaa advisor is one click away — the assistant hands off, it never pretends.

Start your first self-assessment today

OLEA is free to explore — your first framework walkthrough takes about twenty minutes.

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