Biotech and life sciences companies
AI for Biotech
Literature review, regulatory drafting and lab documentation under Part 11, GxP and data integrity rules.
Life sciences companies generate more written material per employee than almost any other business: protocols, reports, submissions, deviations. AI reads and drafts that material well. The regulated parts are validated before AI touches them, and the unregulated parts are where an engagement starts.
Where the hours go
Work that AI can carry.
- 01 Literature review
A question across published papers, patents and internal reports answered with citations for a scientist to verify.
- 02 Regulatory submission drafting support
Sections of a submission drafted from the study reports and the template, for regulatory affairs to edit.
- 03 Lab notebook and protocol search
The protocol, the result or the deviation found by the question rather than the notebook page.
- 04 Deviation and CAPA documentation
Investigation reports and corrective actions drafted from the quality record for QA to review.
- 05 CRO and vendor coordination
Status updates, data transfer requests and queries drafted and tracked across vendors.
What has to hold
The rules an engagement respects.
- 21 CFR Part 11
Electronic records and signatures have requirements, and an AI tool that writes into a regulated record falls under them.
- GxP software validation
A tool used in a GxP process is validated for its intended use, which shapes what the first pilot can be.
- Data integrity (ALCOA+)
Every record stays attributable, legible, contemporaneous, original and accurate, and AI drafts have to preserve that.
- IP protection
Unpublished results and sequences cannot enter a tool whose terms permit retention or training.
- Clinical data privacy
Subject data has consent and jurisdiction rules of its own on top of the rest.
How an engagement runs here
The four steps, as they run in biotech.
- 01 Assess
The assessment separates GxP from non-GxP work, reviews vendor terms against IP exposure, and finds where scientists already use public tools.
AI Readiness Assessment - 02 Plan
The roadmap starts with non-GxP work such as literature review, where the measure is hours and no validation cycle is triggered.
Strategy and Roadmap - 03 Build
The build runs on the company's own documents with retrieval scoped by project, and any step toward a regulated record is validated first.
Implementation - 04 Train
Training covers scientists, regulatory affairs and QA, and the policy states what may and may not enter a tool outside the firewall.
Training and Change Management
Start with the assessment.
An inventory of your systems, data and rules, interviews with your department leads, and a report that says what to do first in biotech.