Batch & Lot Records
Your real procedure, step by step, recorded while the work happens.
Batch & Lot Records builds electronic batch records, lot genealogy, and CoA drafts around the procedure your plant actually runs. Operators record each step as they do it, and your QA team approves every record and releases every lot.
What it does
Most batch records are written twice. Operators fill in a paper record or a spreadsheet on the floor, and someone types it into a system or a CoA template later. Then the QA reviewer pages through the finished record, finds a blank on step 22, and walks back to the floor to ask an operator who has already moved on to the next batch.
We build electronic batch records around the master procedure your plant runs, including the steps that only live in someone's head. Raw-material lots are captured at receipt, and each production step records the operator, the time, the equipment, and the lot. The system checks every completed step against the procedure, flags missing entries and out-of-range values while the batch is still in the vessel, and assembles a CoA draft from the test results and the live spec.
Your QA team approves batch records, dispositions deviations, and releases product. The system records, checks, flags, and drafts, and it never releases a lot. Where your products enter FDA-regulated supply chains, a domain expert joins the work before we promise a production system. We're building Batch & Lot Records with a pilot plant, and we scope each new plant case by case.
What it handles
Electronic batch records
Each step of your master procedure becomes a screen the operator completes, in the order your SOP sets out. Quantities, equipment, times, readings, and sign-offs are entered as the work happens. Each value is entered once, as the work happens.
Raw-material receipt
Supplier lot numbers and supplier CoAs are captured at receiving and tied to every batch that consumes them. If a supplier CoA is missing, the receiving record is flagged for your QA reviewer before the material reaches production.
Lot genealogy
Every finished lot links back to the raw-material lots that went into it and forward to the shipments that carried it out. One record answers what went into a lot and where it went. Each link shows the source entry behind it, so your team can check the answer.
Deviations and nonconformances
When a value falls outside its limit, the record opens a deviation with the batch, the step, and the reading already attached. Your quality team investigates, decides, and closes it. The system never decides a disposition, and any CAPA work stays with your quality team.
CoA drafts
Certificates of analysis are drafted from in-process and final test results against the spec revision that is live today. Numbers go from the test results into the draft, and the system checks the limits. QA checks each draft and approves it before it goes to the customer.
Checks at every step
The system checks each completed step against the master procedure as it closes. Missing entries, out-of-range values, and skipped sign-offs are flagged while the operator is still at the vessel. Your QA reviewer sees only the items that need a decision.
Who it's for
FAQ
Batch & Lot Records questions
Does it release lots?
No. The system records, checks, flags, and drafts, and it never releases a lot. Your QA team approves batch records, dispositions deviations, and releases product. Your quality and regulatory team decides how the system is used in your plant.
What is an electronic batch record?
An electronic batch record is a batch record completed step by step on screen while the work happens. In the batch records we build, each step of your master procedure becomes a screen the operator completes, with quantities, equipment, times, readings, and sign-offs in the order your SOP sets out. Your QA team still reviews and approves every record.
Can it show which raw-material lots went into a finished lot?
Yes. Supplier lot numbers and supplier CoAs can be captured at receiving and tied to every batch that consumes them. Each finished lot can then link back to its raw-material lots and forward to its shipments, so what went into a lot and where it went become one lookup, with the source entry behind each link.
What happens when a value is out of range during a batch?
The value is flagged when the step closes, while the operator is still at the vessel. The record opens a deviation with the context already attached. Your quality team investigates, decides, and closes it, and your QA reviewer sees only the items that need a decision.
Can it draft certificates of analysis?
Yes. A CoA draft is assembled from in-process and final test results against the current spec, whichever revision is live. Numbers go from the test results into the draft, and the system checks the limits. QA checks the results against the limits and approves the draft before it goes to the customer. The draft pulls from your LIMS or from your test-result exports.
How is the batch record built?
We watch your team run a batch and read the master procedure alongside them, including the steps that only live in someone's head. We turn it into a prototype batch record on sample data, and your QA and production leads mark it up before anything is connected. Once they approve it, operators start recording real batches. We set the timeline once we've walked through your first batch together.
Who made each entry, and how are corrections handled?
Every entry records the operator who made it and the time it was made. A correction is added as a new entry, so the original stays visible in the batch history. That history shows who did what, to which lot, and when, and your batch records are kept in your environment. Your QA reviewer sees it alongside the record during review.
You know AI could help. Let’s build it.
Bring us a task you have in mind, or just a hunch. We’ll help you find the right place to start and build it around the way your business works.