Compliance requirements
We review which rules apply (21 CFR Part 11, Annex 11, ESPR) and which records and signatures you must be able to prove.
Service 05 / 05
Traceability and compliance with blockchain
For pharma, food, energy or any audited process: batch and process records that cannot be altered. We integrate your MES, LIMS or ERP with a signed record of every critical action and anchor its fingerprint on a blockchain, so an auditor can check the data has not changed without relying on anyone's word. Designed for 21 CFR Part 11, GMP Annex 11 and the digital product passport.
Problems we solve
Records that can be changed
A database administrator can change a record without leaving a trace. In front of an auditor, that means proving with procedures what the system does not guarantee.
Signatures on paper and loose sheets
Approvals, batch releases and instrument readings signed outside the system are hard to reconstruct and to audit.
Traceability that breaks between companies
The batch is tracked inside the plant but lost when it passes to the supplier, the customer or the carrier.
New product obligations
The digital product passport (ESPR) and FDA and EMA requirements call for verifiable data throughout the product's life.
What we do
We pick the network to fit the case, not the other way round, and integrate it with the systems you already use.
Signed record of critical actions
Every approval, instrument reading or batch release is electronically signed and time-stamped.
Blockchain anchoring
The fingerprint of each record is anchored on a public or permissioned blockchain, as each case requires, to prove it has not changed.
21 CFR Part 11 and Annex 11 compliance
Electronic records and signatures designed for FDA and EMA GMP requirements, with their audit trail.
End-to-end batch traceability
From supplier to end customer, with the data of each stage linked to the batch.
Digital product passport
Verifiable product data under the EU ESPR regulation, and digital machine identity.
Verifiable certificates
Certificates issued as W3C Verifiable Credentials, which a third party can check without accessing your systems.
How we work
A traceability project starts by knowing what you need to be able to prove, and to whom.
Record design and network choice
We define what is signed, what is anchored and on which network, public or permissioned, based on cost, privacy and who must verify.
Integration with MES, LIMS and ERP
We connect the systems that generate the data so the record is created automatically, with no manual steps.
Validation and verification
We test the system with your quality team and document how an auditor verifies each record.
Technologies
We work with several networks and choose the one that fits your case, your budget and who needs to verify the data.
Frequently asked questions
What does blockchain add to traceability?
Proof that a record has not been changed. The cryptographic fingerprint of each signed record is stored on a blockchain; if someone changed the data later, the fingerprint would no longer match. The data itself can stay in your systems.
Does it help with 21 CFR Part 11 compliance?
21 CFR Part 11 requires reliable electronic records and signatures with an audit trail. We design the signed record and its blockchain anchoring for those requirements and for GMP Annex 11. Validating the system in your environment is done with your quality team.
Does our company data become public?
No. Only the record's fingerprint is anchored on the blockchain, and the data cannot be rebuilt from it. When the case calls for it, we use a permissioned network instead of a public one.
Which blockchain network do you use?
The one that fits the case: we work with Hedera, EVM networks such as Ethereum, Polygon or Base, Solana and Cardano. We choose based on cost per transaction, privacy and who needs to verify the data.
Do we have to replace the MES or the ERP?
No. We integrate the signed record with the MES, LIMS and ERP you already have, so data is recorded where it is generated.
Related services
- 02
Systems integration: ERP, MES and enterprise platforms
We connect ERP, MES, CRM and the shop floor so data flows on its own: orders go down to the line, output and consumption come back up. From Siemens, Beckhoff or Omron PLCs to SAP, Odoo or Salesforce.
- 03
Process analysis, improvement and automation
We measure your real process, find the manual steps that cost you time and errors, automate them and measure the saving. Diagnosis with data first, investment second.
- 04
AI agents for business
Agents that work on your documentation, your catalogue and your history: they answer, prepare quotes, open tickets and feed your ERP or CRM. In the cloud or on your own servers.
Shall we talk about your case?
Tell us which process you want to improve. The first analysis meeting is free and we reply within 24 working hours. We travel to plants anywhere in Spain and build software for clients worldwide.