Multi-batch cosmetic PIF: the dossier ready when the authority calls, not weeks later.

The problem

The PIF changes with every batch — and almost nobody keeps it up to date.

EU Regulation 1223/2009 requires the PIF to be available to the competent authority at the address of the responsible person and in a readily accessible form. That is what the letter of the law says; the practice in many plants is different: the dossier is rebuilt when the authority calls. The sources are scattered:

1. Recipe and supplier for the batch — in the ERP, with the supplier contract in a folder belonging to the purchasing manager.
2. Manufacturing parameters — in SCADA or the MES, sometimes only on the machine screen that nobody integrates.
3. Analytical testing from the internal and external lab — in PDFs and emails, with the technical director's signature.
4. ISO 22716 GMP traceability — intermediate cleaning, operator training, incident log.
5. CPSR — signed by the assessor, but tied to the product, not to the batch, unless somebody updates it manually.

The safety manager knows this. But between launching the new color of the season and signing the dossier for batch 1,847 made four months ago, the dossier almost always loses. The day the inspection asks “show me the PIF for batch X”, the regulatory team spends a week rebuilding it from emails, spreadsheets and SCADA — with the uncertainty of not finding everything.

How it fits the IRIS system

iLEAN does not add a fourth system — it seals the cracks between the ERP, the MES and the lab.

The PIF does not fail for lack of data: it fails because the data lives on islands that only come together when somebody spends a week cross-referencing them by hand. iLEAN acts as the putty that fills the gaps between the ERP, the MES, SCADA, the lab and supplier emails — without asking you to change any of them.

Close a batch in SCADA: at second zero, the iLEAN agent is already packaging the complete batch dossier, with a citation to every source document. The safety manager signs; the PIF is archived, ready for inspection.

The specific piece:

• iLEAN Agents — one dossier agent per product family, living in Central. It collects the recipe, parameters, analytics, traceability and CPSR for the batch, cross-references them, checks consistency (could this supplier have supplied this batch? is this cleaning on record?) and delivers the PIF packaged with every document cited back to its source.
• Connect — captures what arrives from outside (the external lab's email with the certificate of analysis, the supplier's updated technical data sheet) at second zero, without anyone forwarding it or calling a meeting.
• Three safety rings — the final dossier is signed with the responsible person's key; whatever is handed to the authority carries the human signature — the Agents propose, the person signs.

See the full IRIS architecture →

Before and after

PIF rebuilt after the fact vs. PIF compiled at batch close

Aspect	PIF rebuilt by hand	With iLEAN Agents + Connect
When it is compiled	When the authority asks	At batch close, automatically
Searching through archives	Days per batch audited	Zero — the dossier is already there
Recipe/supplier consistency	Manual cross-check; frequent errors	Automatic verification batch by batch
Update after a supplier change	The manager finds out when they can	Connect captures the email; the agent flags affected batches
Document ↔ source traceability	Trusting the memory of whoever assembled it	Every data point cited to the original document
Dossier ready for inspection	“Rebuildable in a week”	Access in minutes to the PIF of the batch named

Impact estimate

Impact estimate for your plant — to be validated with your numbers.

The block below is an estimate to be validated with the specific data of your plant. We put it forward so the committee has an order of magnitude; we refine it during the diagnostic.

• Contract manufacturer or brand with a catalog of several dozen to several hundred active SKUs in the EU, several thousand batches a year, across different families (skincare, color, hair care).
• Agents pilot on the family with the highest turnover and the most audits (the low-hanging fruit). First dossier compiled automatically within a few weeks.
• Indicative payback between 4 and 9 months, depending on inspection frequency, the hourly cost of the regulatory team and the hours spent today rebuilding dossiers.
• Expected reduction in response time to a PIF request of ≥ 30% — because the dossier is not rebuilt, it is already there. That is a defensible floor; we refine the ceiling once we have your SKU Pareto.

And the safety manager's reasonable doubt

“What if the agent cites a document wrongly or assigns it to the wrong batch?” — the agent does not invent anything: it recontextualizes data that already exists in your systems, with the citation to the original document visible. The reliability of AI on tasks anchored to a source is below 1.5% error in the best models ^[1]. And the final file is never closed without a human signature — the three rings exist precisely for this.

^[1] OpenAI paper “Why Language Models Hallucinate”, 2025 — on the reliability of AI in anchored tasks.