Deviation Investigations
Investigations that start with everything you already know
Litewave builds the timeline from the source records, retrieves every prior event that resembles this one, and proposes root cause and CAPA candidates with the evidence for and against each. Your investigator decides.
Investigations stall for two reasons, and neither is judgement
The clock on a deviation is a disposition clock. Every day an investigation stays open is a day of inventory that cannot ship.
The first reason is assembly. Pulling the batch record, equipment logs, calibration history, environmental monitoring, training records, change controls and prior lots by hand across five systems, then writing a chronology from them, is days of work before anyone has thought about cause.
The second is memory. Knowing that this same excursion happened on the same vessel eleven months ago, and what actually fixed it, tends to live in one senior investigator’s head, and it leaves when they do. So sites reinvestigate recurring events from scratch, CAPAs get written to the symptom, effectiveness checks quietly fail, and the same deviation returns next quarter with a new number on it.
How it works
- The event record from your eQMS
- Executed batch record and in-process data
- Equipment logs, calibration and maintenance history
- Cleaning and changeover records
- Environmental and utility monitoring
- Analytical data and OOS records
- The site historical deviation and CAPA ledger
- Assembles a fact-checked chronology from the source documents, every entry cited
- Retrieves similar prior events by equipment, product, process step, symptom, material lot and shift
- Drafts hypotheses with supporting and contradicting evidence
- Flags where the record is silent, which is frequently the real finding
- A pre-populated investigation record with scope and impact assessment
- Similar-event history with the outcomes of each
- Candidate root causes with the evidence behind them
- A proposed CAPA and a draft effectiveness check
What it does
Assembling the facts
- Builds a minute-level chronology from batch records, equipment logs and system data, each entry cited to its source
- Runs scope and impact assessment across other batches on the same equipment, material lot or time window
- Identifies other lots requiring extension of the investigation
- Flags gaps where the record does not say what happened
Using the history
- Retrieves prior similar deviations with their root causes, CAPAs and effectiveness outcomes
- Separates recurrence from coincidence by trending frequency across equipment, product, step, shift and operator group
- Surfaces CAPAs that were written to a symptom and did not hold
Reaching a cause
- Drafts hypotheses in your methodology of choice, whether 5 Whys, fishbone or fault tree
- Presents evidence for and against each hypothesis, and states plainly where evidence is absent
- Proposes CAPA candidates linked to the root cause rather than the symptom
- Drafts an effectiveness check with a measurable criterion
Standing up to inspection
- Audits the closed investigation for whether the root cause is supported by the record
- Checks that the CAPA addresses the stated cause and that scope and impact are justified
- Tracks investigation aging and surfaces the ones that will breach your closure target before they do
Where the evidence comes from
At the world’s largest sulfamethoxazole producer, reviewers previously lacked immediate access to historical resolution data, forcing quality teams to investigate recurring anomalies entirely from scratch. The deployment now leverages historical deviation intelligence to compress future investigation cycles. That is the published finding, and we have deliberately not attached a cycle-time percentage to it: the 85% figure on our case study is a batch disposition number, not a deviation number.
Questions we get asked
Does Litewave decide the root cause?
No. It proposes candidates with the evidence behind each, including the evidence against. An investigator accepts, edits or rejects, and their reasoning is what goes into the record.
Do we have to move off our eQMS?
No. Litewave reads from and writes back to the system you already run. The investigation record stays in your system of record.
Our historical deviations are PDFs and Word files. Does that break it?
That is the normal starting state. Structuring the historical ledger is part of onboarding, and it is what makes similar-event retrieval useful from day one rather than after a year of new data.
What happens when there is no clear cause?
It says so. Litewave marks hypotheses as unsupported and lists what evidence would be needed to test them. An investigation that concludes "cause not determined, here is the containment and here is the monitoring" is defensible. One that asserts a cause the record does not support is not.
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.