About the Customer
A mid-size pharmaceutical CMO producing regulated APIs and finished dosage forms for client brands across domestic and export markets, with a high cadence of products being onboarded and deboarded as contracts evolve.
GMP-certified with active regulatory exposure, the customer needed repeatable, systematic verification across a constantly changing product mix, and needed it without adding reviewers every time a new contract landed.
Deployment Overview
Litewave was deployed as a verification layer on top of the customer's existing Batch Process Records, Operations Logs, raw-material data, and analytical outputs, including HPLC chromatograms.
The platform operates with no changes to SOPs or production systems, and every flag it raises is cited back to the underlying source record.
The Challenge: The Cost of Doing All of It by Hand
A reviewer working through a 100–150 page paper batch record is checking thousands of entries: every temperature reading, every duration calculation, every signature, every raw-material entry, each one reconciled against secondary specifications, analytical limits, and chromatogram data held in other documents and other systems. It is done, and it is done by the most experienced people on site. What it costs is hours of sustained concentration per batch, under release pressure.
Sustained cross-document comparison is exactly the task where attention degrades, and what slips through is rarely dramatic: a signature field left blank on page 94, a duration off by ten minutes, a residual solvent result that is in limit on its own but drifting against the last twelve lots. Each carries real weight, a data integrity finding, a process deviation, an ICH Q3C patient-safety question, and each is caught by reading rather than by judgement. The constraint is reviewer hours and fragmented source data, not competence.
Why eBPR Wasn't the Answer
Electronic batch record (eBPR) systems are built on the assumption that you template once and run thousands of batches against that template. For a pure CMO, that math inverts. Each new client product needs its own validated digital template (typically 8 to 16 weeks of engineering and qualification work), and many of those products will only run a handful of batches before the contract winds down. The templating backlog grows faster than throughput, and every deboarded product strands the investment that went into it.
Litewave runs on top of the paper batch records the floor already produces, so a new product is live the day the SOP is, with no validation cycle in the middle.
The Solution: A Three-Tier Verification Engine
Litewave runs three layered verification tiers across every batch, each producing a structured report with evidence linked back to the source record.
Tier 1: Batch Review
- Six GMP compliance checks
- Runs across all 200+ operations
- Pass/fail with source-record evidence
Tier 2: Quality Verification
- Drug substance specification checks
- Residual solvent & moisture limits
- Raw analyst data vs. release record
Tier 3: In-Process Quality
- HPLC chromatogram integrity audit
- Assay + impurity material balance
- Tolerance-based outlier detection
Tier 1: Batch Review Report
Six compliance checks run across every operation in the batch process. Each check produces a pass/fail flag with the underlying records cited inline.
Tier 2: Batch Quality Verification Report
Where Tier 1 verifies the process, Tier 2 verifies the product, checking analytical results against regulatory limits and reconciling release data back to original analyst records.
Tier 3: In-Process Quality Checks
Two analytical integrity checks ensure the data driving release decisions is internally consistent and reconciles back to instrument output.
Value Realized
- •Every batch gets an independent line-by-line check across every operation and every record, so the reviewer starts from a complete picture instead of building one.
- •Every flag carries the underlying evidence with it, making review-by-exception faster and audit response self-documenting.
- •Regulatory anchors (GMP, ICH Q3C, USP, Ph. Eur.) are encoded directly in the verification engine, no separate compliance interpretation step.
Our product mix is constantly changing as new client contracts come in and others wind down, so we weren't sure any AI platform could really keep up with a CMO like ours. Litewave has. It enhances both compliance and productivity in ways our existing systems simply can't, and the depth of pharma-specific knowledge baked into the platform is rare. From day one, the options for review and tracking have significantly improved our workflow and efficiency.