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SoHO Regulation and Donor Human Milk
We are ready! Are you?
From 7 August 2027, the EU’s Substances of Human Origin (SoHO) Regulation will bring donor human milk (DHM) under the same regulatory framework as blood, tissue and cells. Milk banks, hospitals and other organisations handling donor milk will be required to meet enhanced standards for safety, quality, traceability and governance.
What This Means for Human Milk Services
Under the new framework, organisations managing donor human milk will need to:
Maintain complete traceability from donor to recipient.
Capture and retain records throughout the milk lifecycle.
Demonstrate compliance through documented quality management systems.
Support incident reporting, audit readiness and regulatory inspections.
Protect donors and recipients through robust safety controls.
For many milk banks and neonatal services, these requirements will increase the need for reliable digital systems that replace manual processes and fragmented record keeping.
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How Li-LAC and Savant Supports SoHO Readiness
Li-LAC provides a purpose-built platform for managing donor human milk programmes, helping organisations strengthen compliance and operational efficiency.
Key capabilities include:
End-to-end traceability of donor milk from donation through processing, storage and final use.
Comprehensive audit trails to support inspections and regulatory reporting.
Digital record management that reduces reliance on paper-based systems.
Inventory and batch tracking to improve visibility and control.
Quality assurance workflows that support consistent operational processes and standards.
Secure data management to protect users, donor and recipient information.
ISBT128
Li-LAC generates ISBT 128 compliant labels directly within your workflow, so you:
Assign globally unique identifiers to every container & batch.
Standardise labelling across milk banks, hospitals, and transport partners.
Enable reliable barcode validation at receipt, storage, preparation, and administration.
Integrate smoothly with laboratory, pharmacy, and electronic patient record systems.
Maintain unbroken chain of custody records across the entire supply chain.
Demonstrate clear alignment with international best practice and regulatory expectations.
Interested In
Our Li-LAC System
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Contact Savant if you would like to know more about the Li-LAC milk bank control software or any other Li-lac products.
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Contact Savant Ltd To Find Out More About Our Full Range Of Products & Services.
Li-LAC Control Software
Milk Bank Labelling, Control and Tracking
Li-LAC
Milk Bank
Li-LAC MB is a comprehensive management and track-and-trace system that includes donor management, milk labelling, milk testing and milk tracking.
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Maternity
Milk Checking
Li-LAC MMC (Maternity Milk Checking) is HIMSS 6 and Scan4Safety compliant app that runs on a handheld smart scanner.
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Feed
Interfaces
Li-LAC MMC has been enhanced to include a feed interface between the app and Clevermed’s Badgernet EPR system.
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Contact
Savant Ltd
Contact Savant if you would like to know more about the Li-LAC milk bank control software or any other Li-lac products.
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The Benefits of Li-LAC MB (Milk Bank)
As SoHO requirements come into force, healthcare providers will need greater visibility, control and accountability across every stage of donor milk management. Implementing digital systems now can help organisations reduce compliance risk, improve operational efficiency and ensure readiness for future regulatory requirements.
Li-LAC helps milk banks and healthcare providers build the traceability, quality management and governance foundations needed for the evolving regulatory landscape.
we support organisations from the NHS and local government, to SMEs and large corporations.
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