Better documents. Better outcomes.
Andrei drafts and reviews regulated documents against your own SOPs, templates, and approved examples.
The root cause was determined to be operator error during the transfer step. Retraining was completed and the batch was released following quality review.
The chain stops at the person. SOP-QA-008 asks for the procedural gap that let the error reach product.
Release is asserted with no product impact assessment, and the two earlier deviations on this line are never reassessed.
Writing one means pulling facts out of several systems, going back to the teams who did the work to establish what actually happened, then assembling it so a manager can review it against the governing SOP, your own acceptance criteria, and what an FDA investigator will look for. Every round of that takes days.
The report cites a sampling plan but doesn't state AQL. SOP-QA-014 §5.2 requires the sampling level and acceptance number.
Sources: McKinsey, Capturing the value of good quality in medical devices; HFS Research, Pharma manufacturers must turn quality into a revenue accelerator; FDA device warning-letter statistics, FY2025; Pharmaceutical Online, What 2025 FDA warning letters tell us about GMP compliance.
On every document your teams write, against the procedure that governs it.
A test method has to support the TMV that qualifies it. A DFMEA has to agree with the risk file it feeds. Design transfer depends on documents released across process development, packaging, supply chain, and manufacturing. Andrei reads the related documents together and flags what is missing or contradictory between them, before the package reaches review.
A deviation cites a batch record. The batch record assumes a qualified line and a validated method. The annual product review pulls a year of deviations, OOS results, change controls, and stability data into one argument about one product. Andrei reads the related documents together and flags what is missing or contradictory between them, before QA sees it.
Medical device and pharmaceutical teams write different documents. Underneath, the problem is identical: a claim that isn't supported, a required fact that isn't there, a conclusion that contradicts the protocol behind it.
Design controls, verification and validation, process development, and a transfer package that has to hold together at the end. Andrei checks each document against the procedure that governs it — and against the documents it depends on.
Andrei for device teamsGMP investigations, qualification and validation, risk assessment, and the annual review that has to reconcile a year of all three. Andrei drafts in your SOP's structure and checks that every fact the SOP asks for is actually on the page.
Andrei for pharma teamsFor complex decisions like risk classification, process controls, root cause analysis, validation strategy, and design transfer readiness, Andrei keeps the human expert in control.
It highlights gaps, asks guiding questions, suggests improvements, and prepares structured drafts for review. Your team owns the final decision. Andrei helps make that decision better supported, better documented, and faster to reach.
In regulated industries, documentation isn't paperwork. It's how companies prove they designed the product correctly, controlled the process, understood the risks, and justified the decision.
Create structured, review-ready drafts from scattered inputs.
Apply SOPs, templates, and acceptance criteria more reliably.
Find missing information before formal review or release.
Lower document churn during approval cycles.
Support attributable, legible, contemporaneous, and complete records.
Free engineers and quality leaders to focus on technical decisions.
Improve completeness and clarity across regulated documentation.
Keep expert judgment central while AI supports review and drafting.
Three of the questions it asks, and the documents it asks them of.
The results demonstrate that the device meets the acceptance criteria defined in the plan.
Which criteria? They are not restated here, and §4.2 is never referenced. A reviewer cannot verify this without opening another document.
The root cause was determined to be operator error during the transfer step.
The chain stops at the person. SOP-QA-008 asks for the procedural gap that let the error reach product.
All batches met specification and the process is considered validated.
Three runs in §6 sit outside the action limit set in the protocol. The conclusion does not account for them.
Don’t see your workflow? Reach out to us.
We have written and defended the records an investigator eventually reads, and built AI into safety-critical products. Andrei is the tool we wanted on both of those jobs.
Eight years across Boston Scientific and Medtronic, moving between R&D, quality, product, and operations strategy — the four functions that end up arguing over the same document. At Medtronic he led the scale-up of the $975M Affera acquisition, where bringing a new cardiac ablation platform into the business meant reconciling two companies' procedures, templates, and quality systems.
Andrei starts from what he already knew: the week lost chasing one fact across three systems, the reviewer comment that sends a report back to its author for the third time, the SOP that governs a document sitting somewhere its author never looks.
Sachin has been programming since he was 14: simple things through school, full-stack apps in college, then data science — time series forecasting and machine learning. By 2018–19 he was working on attention models, before they were a product category. Seven years at Mercedes-Benz followed, building machine learning and AI systems across ADAS, UI/UX, finance, and marketing and sales.
Different domains, one discipline: build systems that do the mechanical part of an expert's work reliably, and leave the judgment where it belongs. In regulated documentation, reliable means every claim traceable to the procedure behind it.
Andrei is an AI reviewer and drafting engineer for regulated medical device and pharmaceutical teams. It is not a system of record and does not replace the systems you already run. You bring the document types your teams already write — investigations, protocols, reports, assessments, periodic reviews — and Andrei drafts and checks each one against your own SOPs, templates, and approved examples, while your experts stay in control.
Medical device and pharmaceutical teams, including biologics and CDMOs. Device teams work across design controls, verification and validation, process development, CAPA, and design transfer. Pharmaceutical teams work across deviation and out-of-specification investigations, CAPA, change control, qualification and process validation, quality risk assessment, and annual product quality review. See the medical device page or the pharma page for the full list.
No. Andrei keeps human experts in control. It drafts stronger first versions, checks documents against your procedures, and surfaces gaps and inconsistencies, but your quality and regulatory experts make every decision.
There is no fixed list — Andrei works from the document type and the procedure you give it. Teams typically start with deviation and OOS investigations, CAPA plans and effectiveness checks, design verification and validation plans and reports, test method and analytical method validation, equipment and facility qualification, process and cleaning validation, quality risk assessments, change control impact assessments, annual product quality reviews, and design or technology transfer packages.
It drafts and reviews GMP documentation against your own SOPs: deviation and out-of-specification investigations with structured root cause analysis, CAPA plans and effectiveness checks, change control impact assessments, qualification and process validation protocols and reports, quality risk assessments, and annual product quality reviews. It checks whether a conclusion is supported by the evidence cited, whether a root cause chain stops at human error instead of the system gap behind it, and whether every fact the SOP asks for is on the page. The pharma page walks through a deviation end to end.
Yes. Andrei checks documents for completeness, consistency, and traceability against your own SOPs and templates, helping teams keep records attributable, legible, contemporaneous, original and accurate (ALCOA+) and audit-ready.
Send us a document type your team writes often, plus the procedure that governs it. We'll show you Andrei drafting and reviewing against it, and reply within one business day.
aditya@andreihealth.com