Draft faster with confidence
Andrei turns scattered technical inputs into structured, review-ready drafts using your approved examples, templates, procedures, and prior project documentation.
AI for regulated documentation
AI document review and drafting
AI document review and drafting
for regulated teams.
Better documents. Better outcomes.
Andrei drafts and reviews quality documents against your own QMS, SOPs, and templates, so your experts catch gaps earlier and turn scattered inputs into review-ready work.
Built for FDA-regulated teams
ALCOA+
Human-in-the-loop
Your QMS · Your SOPs
One platform for the document lifecycle
Quality documents connect to each other. Andrei reviews them that way.
Design
Process Flow Diagram
Risk
PFMEA & Controls
Method
Test Method & TMV
Validate
Validation Planning
Transfer
Design Transfer
A test method supports a TMV. A PFMEA connects to process controls. A design transfer depends on released documents across process development, supply chain, packaging, and manufacturing. Andrei surfaces missing inputs and inconsistencies across related documents, so the package is complete before review.
The documentation burden
Regulated teams spend thousands of hours proving the work was done right.
Regulated teams create documentation across product design, process development, manufacturing, quality, validation, supply chain, CAPA, deviations, and change control. The work matters, but it repeats across systems, fragments across teams, and gets hard to review consistently.
Process Validation Report · PVR-0472
Reviewing
Acceptance criteria traceable to protocol PV-0472
Gap · SOP-QA-014
The report cites a sampling plan but doesn't state AQL. SOP-QA-014 §5.2 requires the sampling level and acceptance number.
Results in §6 support the conclusion
CHECKED AGAINST12 SOPs · 4 templates
READY FOR REVIEWDraft ready in 40s
9.4%
Of medical device sales is spent on the cost of quality.
$36B
Estimated annual cost of quality across the medtech industry.
57%
Of FY2025 FDA device warning letters cite design-control gaps.
59%
Of FY2025 FDA device warning letters cite CAPA deficiencies, the single most common finding.
Sources: McKinsey, Capturing the value of good quality in medical devices; FDA device warning-letter statistics, fiscal year 2025.
What Andrei does
A tireless quality engineer and drafting partner.
Andrei helps teams create stronger first drafts, find missing information, check documents against internal procedures, and flag inconsistencies before formal review.
Review against your QMS
Andrei reviews documents against your company's own procedures, acceptance criteria, templates, and quality expectations, so issues surface while they're still easy to fix.
Find gaps before delays
Andrei identifies missing inputs and surfaces inconsistencies across related documents, so the final package is complete before review, release, audit, or submission.
Built for regulated workflows
Draft and review the documents your teams rely on every day.
Andrei supports the workflows medical device and biopharma companies depend on, from quality operations through product design and development.
A
Quality management
- CAPA & non-conformancesStructured investigation narratives, root cause analysis support, and effectiveness checks.
- Change controlChange impact assessments drafted and checked against procedure, keeping records ALCOA+ and 21 CFR Part 11 ready.
- Procedures (SOPs)SOP-driven documentation packages that stay consistent with your quality system.
- Customer complaintsConsistent intake, evaluation, and documentation aligned to your complaint-handling SOP.
B
Product design and development
- Design phaseUser requirements, design specifications, DFMEA, design test methods, TMV, design verification & validation.
- Process developmentProcess flow diagrams, equipment qualification, operator instructions, characterization, PFMEA, process validation.
- Launch & regulatory approvalMaster validation plans, design transfer, and package completeness ahead of submission.
- Supply chain & supplier qualityVendor analysis and management, supplier warnings, and production planning documentation.
Human-in-the-loop by design
Andrei helps experts apply judgment. It doesn't replace them.
For 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.
Andrei drafts & flags gaps
↓
Expert reviews & decides
↓
Documented & audit-ready
Why Andrei
Move faster without lowering the bar.
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.
01
Faster drafting
Create structured, review-ready drafts from scattered inputs.
02
Consistent reviews
Apply SOPs, templates, and acceptance criteria more reliably.
03
Earlier gap detection
Find missing information before formal review or release.
04
Reduced rework
Lower document churn during approval cycles.
05
ALCOA+ mindset
Support attributable, legible, contemporaneous, and complete records.
06
Higher-value work
Free engineers and quality leaders to focus on technical decisions.
07
Audit readiness
Improve completeness and clarity across regulated documentation.
08
Human control
Keep expert judgment central while AI supports review and drafting.
In practice
Review questions Andrei helps answer and documents it helps draft.
Review questions
Andrei can help answer
- QAre design requirements measurable, testable, and traceable?
- QWere sampling plans selected according to the correct SOP?
- QAre acceptance criteria clearly defined?
- QDoes a TMV or validation report meet the approved plan?
- QAre process risks, controls, and mitigations properly documented?
- QAre required sections missing from a CAPA, deviation, or change control?
- QAre conclusions supported by the evidence in the document?
Drafting support
Documents Andrei can draft
- Design verification plans and reports
- Test method validation plans and reports
- Equipment qualification reports
- Process characterization summaries
- Process validation & master validation plans
- PFMEAs and risk documentation
- CAPA & deviation narratives
- Change control impact assessments
- SOP-driven documentation packages
FAQ
Answers for regulated teams.
What is Andrei?
Andrei is an AI quality reviewer and drafting engineer for regulated medical device, biotech, and pharmaceutical teams. It helps you draft and review critical quality documents against your own QMS, SOPs, and templates, while your experts stay in control.
Which industries and workflows does Andrei support?
Andrei supports medical device and biopharma teams. It helps with quality management documentation, including CAPAs, non-conformances, deviations, and customer complaints, plus product design and development documentation across design, process development, and launch.
Does Andrei replace human reviewers?
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.
What documents can Andrei draft?
Andrei can draft design verification plans and reports, test method validation plans and reports, equipment qualification reports, process characterization summaries, process and master validation plans, PFMEAs and risk documentation, CAPA and deviation narratives, change control impact assessments, and SOP-driven documentation packages.
Does Andrei help with ALCOA+ and audit readiness?
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.
Andrei
- Create better drafts.
- Review against your procedures.
- Find gaps before they become delays.
- Move faster without lowering the bar.
Get in touch
See Andrei on your own documents.
Tell us about your quality workflows and we'll show you how Andrei drafts and reviews against your QMS. We'll reply within one business day.
aditya@andreihealth.comReviews against your own SOPs, templates & acceptance criteria
Human-in-the-loop, your team keeps final control
Built for FDA-regulated medical device & biopharma teams