GMP · Data integrity · Computerised systems · Validation

Understand what GMP needs — for your actual systems.

You don't need to already be a regulatory expert to know what to consider, why it matters, and what documentation to prepare. Describe your environment, answer a guided assessment, and get a tailored view of the requirements that apply, the gaps to close, and the documents you should prepare — every conclusion traceable to its source.

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How it works

From your environment to review-ready documentation

STEP 1
Describe environment
STEP 2
Guided assessment
STEP 3
Applicable requirements
STEP 4
Identify gaps
STEP 5
Documentation needs
STEP 6
Assist with drafts
STEP 7
Human review & approval

Plain-language, not generic

Different labs, systems, users, integrations and risks need different answers. The assessment adapts — around 40 questions that skip what's irrelevant and dig deeper where risk appears — so the result reflects your environment, not a one-size template.

Traceable to the source

Every requirement links back to authoritative sources — EU GMP (Chapter 4, Annex 11, Annex 15), EMA, PIC/S, MHRA, FDA and WHO. Conclusions show which of your answers led to them, so nothing is a black box.

Documentation you can act on

See what documents are appropriate, what to include, what's still missing, what to test and what needs human review — with tailored draft scaffolds to start from. Always a draft for your quality unit to approve.

Clarity you can trust

We always tell you what kind of statement you're reading

Regulatory expectations aren't all the same weight. Alcoa.online clearly distinguishes:

Requirement legally-referenced GMP requirement Regulatory guidance from an authority Draft / upcoming not yet in force Industry guidance widely used practice Alcoa.online view our practical recommendation

Commercial frameworks such as GAMP 5 are referenced only as publicly described concepts — their copyrighted content is never reproduced.

Free and genuinely useful. The guided assessment, plain-language explanations, source references, gap identification and documentation checklists are free. AI-assisted document drafting and professional review are planned as later, optional services. Alcoa.online supports your process — it does not replace GMP expertise, and anything it produces is a draft requiring appropriate human review and approval before use in a regulated quality system.
Start your assessment — it's free