Life Sciences: Cell/Gene Therapy
Traceability You Can Trust, Donor to Patient
Cell and gene therapies are among the hardest products in life sciences to manufacture. Oraya® helps cell and gene therapy organizations put an SAP foundation in place for donor tracking, patient-specific production, quality compliance and protected health data, well before commercial volumes make getting it right even more difficult.
Get the foundation right early
Cell and gene therapy companies are creating something the industry has never produced at scale: personalized, living medicines made one patient at a time, and next-generation biologics that demand a level of process precision traditional pharmaceutical plants were never designed for.
Compared with conventional drug production, these therapies add complexity to every system you run. Patient identity has to be preserved at each manufacturing step. Protected health information must be secured across the whole operational landscape. And every batch, which is often a single dose for a single person, needs to be traceable from collection to release with no tolerance for error.
Most companies in this space run into these issues during clinical development, before the full burden of commercial compliance arrives. Oraya® works with clinical-stage and precommercial cell and gene therapy organizations to implement SAP solutions shaped around the particular demands of the field, and ready to scale as the therapy does.
Industry Spotlight
HIPAA
Because cell and gene therapy production is linked to individual patients, your operating systems store protected health information. That turns compliance with the Health Insurance Portability and Accountability Act (HIPAA) into an enterprise resource planning (ERP) requirement, not only an information technology (IT) policy. Oraya® configures SAP environments that keep patient data secure across manufacturing, quality and distribution from the first day of operation.
Outcomes we deliver
Run patient-specific, make-to-order production with lot and batch traceability down to the individual unit.
Classify and track biological materials, cell types and therapy variants in one compliant system.
Coordinate the full patient journey, lining up apheresis appointments, manufacturing slots and treatment-center readiness through integration with specialized cell therapy orchestration platforms.
Safeguard patient data in every operational system with HIPAA-aligned SAP configuration and role-based access.
Establish GxP-compliant quality processes, including deviations, corrective and preventive actions (CAPAs) and change control, built for the speed and precision of cell and gene therapy production.
Lay a scalable SAP foundation during clinical development that carries into commercial manufacturing without a rebuild at launch.
Meet CBER expectations with validated processes, electronic records and audit-ready documentation.
Validation-ready implementation
Oraya® runs every SAP program with a structured validation approach designed for regulated environments, aligned with GAMP 5 guidance and the FDA’s risk-based Computer Software Assurance (CSA) model.
Our process includes:
Validation plan
A validation plan scoped to your products, sites and regulatory context.
IQ/OQ/PQ protocols
Installation, Operational and Performance Qualification (IQ/OQ/PQ) protocols and execution.
Traceability matrix
A complete traceability matrix that ties each requirement to its test evidence.
Continuous validation
Ongoing validation support through SAP releases, upgrades and configuration changes, so your validated state stays current instead of being proven once.
We partner with an experienced life sciences validation specialist to support clients from initial validation through long-term compliance.
SAP capabilities for cell and gene therapy
Oraya® supports every SAP Cloud ERP deployment model, helping regulated clients choose the architecture that matches their compliance posture, IT strategy and timeline. SAP brings together patient identity, biologics manufacturing complexity and regulated quality management, the combination that defines cell and gene therapy operations:
- Make-to-order production set up so every manufacturing order is tied to a specific donor or patient record, preserving COI across the entire vein-to-vein process and documenting COC at each material handoff with electronic signatures
- Donor and material classification that supports biological material tracking, donor screening status and lot-level traceability from collection to release
- HIPAA-aligned data design within SAP S/4HANA that secures protected health information across manufacturing, quality and logistics with role-based access and full audit trails
- Integrated quality management for GxP environments, including batch records, deviations, CAPAs, change control and electronic signatures that satisfy 21 CFR Part 11
- Data integrity controls aligned with ALCOA+ principles (attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available), a continuing focus for regulators worldwide
- Process and documentation frameworks that scale from clinical batches to commercial production without breaking regulatory continuity
- SAP Extended Warehouse Management (EWM) set up for cryogenic and ultra-cold storage, with location-level traceability for temperature-sensitive materials and links to specialty cold-chain couriers all the way to the patient
- SAP Intelligent Clinical Supply Management to connect clinical supply planning, forecasting, manufacturing and distribution of investigational product across trial sites
- Connections to the platforms you already run, including MES and LIMS, keeping compliant data flowing across the full technology stack instead of replacing tools that already work
