TRThe record is no longer optional. It is a condition of operating
The question an inspection asks of a cell and tissue facility has changed. Not "did you store it correctly" but "can you prove you stored it correctly". The record structures in our products are built to the expectations of the frameworks below.
Frameworks that bind you
Turkey — Regulation on Products Derived from Human Tissues and Cells
Turkey's national regime for tissue and cell establishments. It requires a traceability system, labeling aligned with the Single European Code, and retention of records in electronic form for at least thirty years after clinical use. It is the framework our Turkish installations run under, and the reason our record structures are built for decades rather than years.
International Standards for Hematopoietic Cellular Therapy
The accreditation framework for transplant and cellular therapy programs, jointly issued by FACT and JACIE. It covers traceability of the product from collection through infusion, quality management records, and outcome analysis. Our transplant module is structured so that the evidence an inspection asks for can be produced from the system rather than assembled by hand.
Coding and labeling of cellular therapy products
A globally unique Donation Identification Number, an international product description code, and a standard label layout. Required by FACT, JACIE and AABB standards since 2008. A product labeled to this standard remains readable at any center that receives it, which is the point of the scheme.
Electronic records and electronic signatures
Where records are kept electronically instead of on paper, this sets the expectations for access control, audit trail, electronic signature and system validation. EU GMP Annex 11 is the European counterpart. Our platforms implement user and IP level audit trails, signature binding and record retention against both.
Manufacture of sterile medicinal products and cleanroom monitoring
Requires continuous monitoring and recording of differential pressures identified as critical, together with warning systems and a contamination control strategy. Applied alongside ISO 14644 classification. This is the requirement the GE-100 MultiSensor was designed for.
Biotechnology — Biobanking — General requirements
Sets competence, impartiality and quality assurance requirements for biobanks, including end-to-end traceability of the sample and an unbroken chain of custody. Our biobank module addresses these process requirements directly; ISBER Best Practices, fifth edition, is used as operational guidance alongside it.
Turkey — Cord Blood Banking Regulation
Turkey's licensing regime for cord blood banks. Oxygen and temperature monitoring in the storage area, an alarm mechanism, generator and uninterruptible power supply, and a nitrogen leak warning system are conditions of the license, and a thirty-year electronic archive has been required since 2005. Two decades of building to these conditions is where our cord blood experience comes from.
A risk-based approach to compliant GxP computerized systems
The reference lifecycle for computerized system validation: risk-based scaling of effort, software categories, and the specification and verification stages. Cited by FDA and EU inspectors, and applied together with the ALCOA+ data integrity principles. Our validation packages follow this structure.
What changed
Across jurisdictions the record has stopped being a matter of good practice and become a condition of operating. Establishments are required to retain records electronically for decades, to code and label to a recognized standard, and to prevent unauthorized addition, deletion and modification. For most centers this means paper forms and spreadsheets no longer suffice: the traceability system, the audit trail and the long-term archive have to be built together.
How our products answer it
- Procurement, processing, storage, distribution and clinical use records in one traceability system
- ISBT 128 coding and label printing
- User and IP level audit trail, electronic signature, role-based access
- Maintenance, calibration and business continuity records for critical equipment
Let us talk about your compliance scope
Tell us about your audit history and record infrastructure and we will map what each framework asks for.