AI that drafts, checks and routes regulated documents against the standards that govern them.
Engagement
Fixed-scope project · 8–14 weeks
What it is
We build document systems for regulated work. AI generates documents from approved templates, checks them against standards such as FDA, EMA, WHO-GMP, CDSCO and ISO requirements, routes them for e-signature, and keeps a full audit trail.
Who it's for
Pharma, life sciences, BFSI and any industry with heavy documentation requirements.
The outcome
Faster submissions and fewer audit findings.
Step 1
Document inventory
Map document types, standards and approval chains.
Step 2
Rules and templates
Encode the checks and templates with your quality team.
Step 3
Build and validate
Build the workflow and validate it to your quality system.
Step 4
Go live
Train users and monitor first submissions.
Yes. We design for computerised-system validation and provide the documentation your quality team needs, including for 21 CFR Part 11 and EU Annex 11 controls.
No. AI drafts and checks; qualified people approve and sign.
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