BIOSECURE module wheel: patient and donor management, clinical product orders, apheresis and bone marrow processes, GMP manufacturing, quality control, storage management, materials and warehouse, environmental controls, ISBT 128 coding and labeling, reporting, and user and application management arranged around a single platform — Institutions license the modules they need. What each module covers is in the table below.

BIOSECURE is a web-based process management platform for organizations that handle biological products of human origin. It links the chain that is normally split across paper forms and spreadsheets: patient and donor records, collection, transport, processing, quality control, cryopreservation, physical storage location, release and distribution — each step attributable, timestamped and reconstructable years later.

Why a general inventory system is not enough

Three routes lead to the same place here. Rigid single-workflow products impose one vendor's idea of a process and ask your SOPs to be rewritten to fit the software. Generic systems plus custom code turn every change into a development project, with the validation burden that follows it. And hospital information systems do not cover cryogenic storage, apheresis workflows or GMP batch records. The gap between systems gets filled with spreadsheets and paper — which is exactly where traceability breaks.

Generic inventory software answers "what and how many." Biological products require different questions: which patient or donor is this product linked to, which acceptance criteria did it pass, who processed it and in which room, which consumable lots were used, what were the quality control results, at what temperature has it been held since, and to whom was it released. BIOSECURE models these as one connected record rather than several disconnected ones.

Modules

Module	Scope
ISBT & Monitoring	Haematopoietic transplant and apheresis: diagnosis, donor workup, collection, processing, cryopreservation, infusion
Biobank	Sample mapping and barcoding down to tank, rack, box and position; cryogenic label printing
Cord blood	Collection, processing window, testing, cryopreservation, quarantine and release
HDBO — GMP manufacturing	Product-specific process design, in-process quality gates, consumable and equipment linkage, batch records
Quality control	Cell count, viability, sterility, endotoxin, mycoplasma, flow cytometry, stability; instrument integration
Stock	Hierarchical warehouse, quarantine to release, FEFO, expiry alerts, consumption against production
Environmental monitoring	Device and ambient data via GE-MON, linked to the product record

BIOSECURE patient record: the process trail of a closed diagnosis — diagnosis recorded, product collection, processing and infusion, each step dated and marked complete, with tabs for products, test results and documents — All steps under a diagnosis appear on one screen, with their dates.

BIOSECURE patient list: patient number, name, status badge and diagnosis columns, with filters for status, diagnosis, identifier, sex, year of birth and blood group — The patient list can be filtered by status, diagnosis, identifier, blood group and year of birth.

Built for audited environments

The record structure follows 21 CFR Part 11 and EU GMP Annex 11 expectations: role-based access, user and IP level audit trail, electronic signature, controlled change management and long-term retention. Labeling follows ISBT 128 as published by ICCBBA. Process coverage is aligned with FACT-JACIE standards for haematopoietic cellular therapy and, for biobanks, with ISO 20387.

Software alone does not deliver compliance or accreditation. BIOSECURE is designed to produce the records an audit asks for; validation scope and qualification remain the responsibility of the operating organization, and we support that work.

Configuration, not customization

Cell and tissue products differ in step count, sequence and data pattern, and the flow is often not fully known before manufacturing begins. Processes are therefore defined through a drag-and-drop process designer rather than written into code. A quality control gate can be attached to any step, blocking progression until results are entered.

Integration

Hospital information systems over HL7 and SOAP; laboratory information systems and ERP over REST
Devices and sensors over MQTT and Modbus through GE-100, GE-202 and GE-EDGE
Direct protocol reads from PHCbi, Haier, Worthington/IC Biomedical, Chart MVE, Nüve and comparable controllers
Quality control instruments for automated result capture

Deployment and licensing

BIOSECURE runs on open-source infrastructure (Java and PostgreSQL) either on the institution's own server or in a cloud environment the institution designates. Licensing is an annual subscription that includes installation and support; there is no separate database or application server license. Updates are included during the support period, remote assistance is provided over VPN, and user training is repeated on request.

Talk to our team

Tell us your process steps and device list, and we will prepare a scoped proposal.

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