Pharmaceutical & Biotech
AI for pharmaceutical and biotech quality
Batch review, deviation investigations, supplier quality and product quality review, automated across the batch records, analytical data and quality systems you already run. In production today at an FDA inspected, WHO-GMP certified API manufacturer.
The rulebook your site is inspected against
US cGMP
- 21 CFR Parts 210 and 211, current good manufacturing practice for finished pharmaceuticals
- 211.100 production and process controls, 211.188 batch production and control records
- 211.192 batch record review and investigation of discrepancies
- 211.180(e) annual product record review
- 211.84 testing and approval of components, containers and closures
Records and computerised systems
- 21 CFR Part 11, electronic records and signatures, audit trails and authority checks
- EU GMP Annex 11 for computerised systems
- Data integrity expectations expressed as ALCOA and ALCOA+
- Validation of the systems that create and hold the records
EU GMP
- EudraLex Volume 4 Part I chapters covering documentation and quality management
- Annex 15 qualification and validation
- Annex 16 Qualified Person certification and batch release
- Annex 1 for sterile products
ICH
- Q7 for active pharmaceutical ingredients
- Q9 quality risk management and Q10 pharmaceutical quality system
- Q3C residual solvents
- Q2 and Q14 for analytical procedures
The documents this actually touches
Master batch record and executed BPR. Analytical test records. HPLC and GC chromatograms and raw instrument data. Certificates of analysis. In-process check sheets. Equipment logs, calibration records, cleaning and changeover records, line clearance.
Environmental and utility monitoring. Deviation, OOS and OOT records. CAPA. Change control. Stability data. APQR and PQR. Training records. Validation protocols and reports.
Your workflow, mapped
What your team does today
Batch record review and disposition
What Litewave automates
Batch Review & Release
What your team does today
Deviation, OOS and discrepancy investigation, CAPA
What Litewave automates
Deviation Investigations
What your team does today
Component testing and supplier qualification under 211.84
What Litewave automates
Supplier Quality & CoA Review
What your team does today
APQR, PQR and continued process verification
What Litewave automates
Quality Analytics
Where Litewave is already running
Each of these maps to a real deployment or a customer we work with today.
APIs and intermediates
In productionWhere our flagship deployment runs: high-volume production lines on entirely paper-based records, in continuous production.
Contract manufacturers and CDMOs
In productionHigh product churn defeats eBPR templating, because each new product needs its own validated template. Litewave goes live the day the SOP does.
Sterile fill-finish
Where every day of documentation delay is inventory that cannot ship, and where deviation closure cycle time is the constraint.
Sponsors overseeing external manufacturing
One audit-grade view across CDMOs running different MES, LIMS and document platforms, without forcing partners onto one system.
Proven in production
At the world’s largest sulfamethoxazole producer: an FDA compliant, WHO-GMP certified API manufacturer with more than $600M in annual revenue, running 100 to 150 page paper batch records across its production lines.
How the World's Largest Sulfamethoxazole Producer Cut Batch Disposition Time by 85%
AI-driven QA acceleration with full audit readiness, cutting batch disposition time by 85% and hands-on review from days to hours across paper-based records, with no infrastructure changes.
Read the case study →How a Mid-Size Pharma CMO Automated 200+ Compliance Checks per Batch
Replacing reviewer-driven spot checks with 11 automated compliance checks across every operation, every flag backed by source-record evidence, across a constantly changing product mix.
Read the case study →Questions we get asked
Do we need an eBPR or MES before this is useful?
No. Our reference deployment operates as a digital layer directly over legacy paper batch records, with no structural infrastructure changes and no eBPR overhaul.
How does this hold up in an inspection?
Every extracted value and every flag links back to the source page it came from, so an inspector can drill from a finding to a scanned batch record page in the same session. Litewave supports Part 11 aligned electronic records and audit trails.
Who makes the release decision?
You do. Litewave performs the review and assembles the evidence. The disposition decision stays with your qualified person, in your own quality system.
Related
Built for validated environments
Your data stays where your auditors expect it
Deploy in your environment
Your cloud, your data center, on the plant floor, or fully air-gapped. The same agents run identically in all four.
Your data never trains our models
Documents are never sent to third-party AI providers and are never used to train any model, ours or anyone else’s.
21 CFR Part 11
Electronic records, electronic signatures and complete audit trails on every action, built to ALCOA+ data integrity principles.
EU GMP Annex 11
Meets European GMP expectations for computerised systems used in regulated manufacturing.
Evidence on every flag
Every extraction, check and recommendation links back to its source page. Nothing asserted is unverifiable.
Human in the loop by design
Agents propose, qualified people approve. Litewave never dispositions a batch on its own.
See it run on one of your own records
Bring something real. We will show you what Litewave finds in it and what it cites as evidence.