The parameters you already measure become your evidence.
Process temperature, pressure, cycle times: your sensors have been reading them for years. Meddle records them automatically against the batch, checks them against limits while the process runs, and keeps the whole set in a form that still holds up to an inspection three years from now.
- Automaticthe record no longer depends on who fills the form
- Per batchparameters tied to the batch, not just to a time of day
- Immutablean audit trail on every read and every write
Why compliance costs more than it should
The record is manual
An operator reads the value and transcribes it onto a form. The data already exists digitally in the PLC, but the evidence that reaches the file is a hand-copied signature on paper.
Deviations surface at end of shift
If the check happens against a completed log, the excursion emerges once the batch is already closed. At that point the options are downgrade or recall, not correction.
The audit becomes a project
Reconstructing a batch from two years ago means cross-referencing paper files, SCADA exports and the memory of whoever was there. Those weeks are the real cost of not having traceability.
Three steps, from sensor to batch file
Tie the parameter to the batch
Critical values come from the PLC and receive the context that makes them evidence: batch, recipe, line, shift, operator, moment of reading.
Check while the process runs
Every parameter is validated against its limits in real time. A deviation is notified within minutes, while there is still room to act on the batch.
Keep it in verifiable form
Timestamped records with an audit trail on every access and change, exportable at any time in whatever format the file requires.
Plain-language questions, answers from your own plants
- Show me every critical parameter for batch 2026-0418.The batch's complete record: values, limits applied, deviations and reading times, in a form you attach to the file without transcribing anything.
- Which batches had a deviation this month, and on which parameter?A per-batch list with the out-of-limit parameter, how long the excursion lasted and its outcome. The periodic review, already assembled.
- Does line 3 hold temperature limits consistently?The distribution of values across the period with the limits overlaid: you can see whether the process is centred or running permanently close to the edge.
- What happened in the fifteen minutes around yesterday's deviation?The window with every parameter on that line overlaid, so the cause is looked for in the data rather than in the memory of whoever was on shift.
What an inspector actually asks for
- An audit trail on reads and writes. Every access and change leaves a trace with user, timestamp and previous value. That property is what separates a record from a spreadsheet.
- History that stays readable. Data stays at original granularity and exportable, so a batch from three years ago reconstructs in minutes and does not depend on the platform still being in use.
- Meddle records, it does not certify. The platform supplies the measurement, the context and the trail; process qualification and validation stay with whoever is accountable for them. Anyone promising otherwise is selling you a risk.
Let's start with one regulated line.
A guided pilot on the line with the tightest constraints: critical parameters move to automatic recording, and the time freed from transcription work is visible straight away.
Frequently asked questions
Is Meddle a validated GxP system?
No, and the distinction matters. Meddle collects, records and retains data with an audit trail and timestamps; validating the system in your context and qualifying the process remain with you and your consultant. The platform supplies the evidence, not the attestation.
Does it replace our quality system?
No. It replaces the manual transcription of process parameters your sensors already measure, and feeds the quality system with data that was never hand-copied. The rest of the quality system stays where it is.
How does a parameter get tied to the right batch?
From context the line already exposes: production order, loaded recipe, batch start and end signals. Where that link is not available automatically it is taken from the MES or ERP as an additional source.
Can the data be altered?
Records are not overwritten: any change creates a new version and the previous one stays inspectable, with the user and time of the change. That is precisely the property an inspection checks first.
Is it useful for HACCP and IATF 16949?
The kind of evidence those schemes require — critical parameters measured, limits applied, deviations tracked and retention verifiable — is what the platform produces. How that evidence fits into your plan remains your decision.
Let's see how much of your batch file fills itself in.
In a guided demo we start from your critical parameters and your own limits, not from an example.
Book a demo