How a Mid-Size Pharma CMO Automated 200+ Compliance Checks per Batch

200+Operations verified per batch

11Automated compliance checks

100%Line-item coverage

3Verification tiers

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 to shift from reviewer-driven sampling to systematic verification across a constantly changing product mix, without growing headcount.

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: Sampling Is Not Verification

Pharmaceutical batch review is, in practice, sampling. A reviewer working through a 100–150 page paper batch record cannot realistically check every temperature reading, every duration calculation, every signature, every raw-material entry, let alone reconcile each against secondary specifications, analytical limits, and chromatogram data.

Yet that's precisely what GMP requires. A missing signature is a data integrity finding. A duration off by ten minutes is a process deviation. A residual solvent above the ICH Q3C limit is a patient-safety risk. Sampling-based review puts the burden of catching all of this on a small number of senior reviewers working under release-pressure.

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.

Temperature Check

Verifies the temperature recorded in the Operations Log matches the mandated range defined in the Operational Specification, ensuring compliance with established protocols.

Duration Calculation Check

Confirms the reported duration of an operation matches the actual elapsed time between its recorded start and end timestamps.

Date Range Check

Verifies that all operation dates fall within the batch processing period defined in the Batch Process document, a critical GMP requirement for executing every manufacturing step within the approved timeframe.

Signature Presence Check

Confirms every process operation record has non-empty "performed by" and "checked by" fields, establishing accountability that the process was executed according to procedure.

Raw Material Check

Cross-verifies charged material quantities between the process operations log and raw-material records, ensuring traceability, inventory accuracy, and production conformity from receipt through charging.

QC Data Verification

Reconciles actual in-process performance metrics from the main BPR operations log against the validated specifications in the secondary document appendix.

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.

Methanol Content

Verifies residual methanol against ICH Q3C limits. As a Class 2 residual solvent widely used in drug synthesis and purification, methanol is highly toxic, accurate calculation is critical to patient safety, regulatory compliance, and final product quality.

Loss on Drying (LOD)

Confirms moisture content meets product-monograph limits from USP, Ph. Eur., and other pharmacopoeias, typically below 1% for many APIs, ensuring stability and finished product quality.

Result Traceability

Verifies that the final results reported in the Batch Release Record match the original raw data generated by the analyst, eliminating transcription gaps as a source of audit findings.

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.

HPLC Integrity Audit

Performs a data integrity audit comparing recorded impurity percentages against the raw HPLC chromatogram data within specified tolerance, catching transcription and calculation errors before release.

Material Balance Check

Cross-checks assay (potency) and non-assay related substances (impurities and degradation products) to verify total material balance, confirming Assay + Total Impurities ≈ 100% as a release sanity check.

Value Realized

•Every batch is verified line-by-line, every operation, every record, replacing sampling-based review with comprehensive coverage.
•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.

Director of Operations, Mid-Size Pharma