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, in its currently effective form
- The draft revised Annex 11 and the draft Annex 22 on artificial intelligence, tracked while they remain in consultation
- Data integrity expectations expressed as ALCOA and ALCOA+, and the MHRA data integrity guidance
- Validation of the systems that create and hold the records, following GAMP 5 second edition
EU and UK 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
- UK GMP as enforced by the MHRA post-Brexit, including the MHRA data integrity guidance
ICH and international
- Q7 for active pharmaceutical ingredients
- Q9(R1) quality risk management and Q10 pharmaceutical quality system
- Q3C residual solvents
- Q2 and Q14 for analytical procedures
- The PIC/S GMP Guide, where your site is inspected by a PIC/S participating authority, and WHO GMP for prequalified supply
AI in a GxP environment
- The EMA and FDA guiding principles of good AI practice in drug development, January 2026
- EMA reflection paper on the use of artificial intelligence in the medicinal product lifecycle
- The FDA draft guidance on considerations for the use of AI to support regulatory decision-making for drug and biological products, and its risk-based credibility framework
- The draft EU GMP Annex 22 on artificial intelligence, tracked while it remains in consultation
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
SOP and QMS document control, internal audit and regulatory gap assessment
What Litewave automates
QMS & Regulatory Compliance
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
Eleven automated compliance checks across every operation in every batch, every flag backed by source-record evidence, across a constantly changing product mix.
Read the case study →Qualifying Litewave in your quality system
Litewave is a computerised system in a GxP environment, so it is validated like one. Risk-based, against your intended use, under your own procedure.
- The validation documentation you need to qualify Litewave in your environment, scoped with you during procurement
- 21 CFR Part 11 and Annex 11 assessments covering audit trail, electronic signature and access control
- Model documentation: intended use, base model and version provenance, performance measured on your own records, and known limitations
- The intended use and the risk classification for each workflow
- Approval of the validation plan and the acceptance criteria, under your CSV or CSA procedure
- Execution or witnessing of PQ on your own records, alongside your reviewers
- Approval of the validation summary report and release of the system for GxP use
- Change control on every model, rule and configuration change, with regression evidence before release
- Ongoing performance monitoring against the agreed acceptance criteria, including drift
- Periodic review, with the performance evidence retained and available for inspection
- Requalification triggered by change and by review outcome, not by the calendar alone
Governing the AI itself, not just the software around it
A validated system is not the same as a governed model. Both are in scope, and we document both.
In January 2026 the EMA and the FDA jointly published Guiding principles of good AI practice in drug development, ten principles covering AI used across the drug product lifecycle including manufacturing. They are the clearest statement yet of what regulators on both sides of the Atlantic expect, and Litewave is built to them: a defined context of use for every agent, a risk-based and proportionate approach to validation, human-centric design where a qualified person makes the decision, documented data provenance, lifecycle management with scheduled monitoring for drift, and explanations a reviewer can actually read.
The same expectations run through the EMA reflection paper on artificial intelligence in the medicinal product lifecycle, the FDA draft guidance on AI to support regulatory decision-making with its risk-based credibility framework, and the draft EU GMP Annex 22. Annex 22 is not in force, and the revision of Annex 11 is still in consultation, so we hold Litewave to the Annex 11 that is currently effective and build against the drafts rather than claim compliance with them.
Questions we get asked
How is Litewave validated for GxP use?
As a computerised system, under your procedure. We supply the validation plan and risk assessment, requirement and design specifications with a traceability matrix, IQ, OQ and PQ protocols with executed evidence, a supplier assessment pack, and Part 11 and Annex 11 assessments. Your quality unit sets the intended use and risk classification, approves the acceptance criteria, and signs the validation summary report. Model and rule changes then run through change control with regression evidence, and performance is monitored against those criteria for as long as the system is in use.
Are you a US-only product?
No. The checks are configured to the standard your site is inspected against, whether that is US cGMP under 21 CFR 210 and 211, EudraLex Volume 4 and its annexes, UK GMP as enforced by the MHRA, the PIC/S GMP Guide or WHO GMP. Our published pharmaceutical deployments happen to be at an FDA inspected, WHO-GMP certified manufacturer, which is why FDA appears in the case study figures, but the rulebook is configuration rather than something baked into the product.
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, because the models are open-source and served inside your perimeter, so inference never leaves it.
Your data never trains our models
Documents are never sent to third-party AI providers, and they never train a model that any other customer touches. Where a model does adapt to your site, the handwriting engine learning your operators, that loop is closed inside your deployment and what it learns stays yours.
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, and building for what is next
Meets the currently effective Annex 11 expectations for computerised systems. We are building against the draft revised Annex 11 and the draft Annex 22 on AI while both remain in consultation, so nothing here is claimed as compliance with a standard that is not yet in force.
Validated like the computerised system it is
A risk-based validation package written to GAMP 5 second edition and Annex 15 expectations: specifications and traceability matrix, IQ, OQ and PQ protocols with executed evidence, and a supplier assessment pack, so your quality unit can qualify Litewave under its own CSV or CSA procedure.
AI governance you can inspect
Context of use, model versions, performance monitoring and change control are documented against the EMA and FDA guiding principles of good AI practice in drug development, so the model sits inside your quality system rather than beside it.
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.