R&D and clinical operations
SAP S/4HANA, SAP Document Management, SAP Quality Management, SAP regulatory compliance tools and SAP clinical supply management
Life Sciences
Run Safer, Smarter and Faster Life Sciences Operations on SAP
Oraya® helps growing life sciences and healthcare organizations simplify operations, strengthen compliance, deepen patient and partner engagement and speed up innovation, all on SAP’s industry-leading digital platform.
Expertise that safeguards quality, compliance and continuity
Life sciences companies work under constant pressure: tighter regulatory scrutiny, volatile supply chains, climbing research and development (R&D) costs and a race to commercialize faster than ever. SAP supplies the platform, and Oraya® makes it work for your business.
Oraya® brings life sciences depth, proven SAP delivery models and industry accelerators to pharmaceutical and biotech, medical device, contract development and manufacturing, cell and gene therapy and donor and tissue processing organizations, helping them:
- Stay compliant end to end with 21 CFR Part 11, cGMP, DSCSA and more.
- See further across global supply chains.
- Cut operational waste and inefficiency.
- Get ready for rapid growth and commercialization.
- Modernize technology without slowing R&D or quality operations.
We help life sciences organizations run smarter, from clinical development through commercial distribution.
Outcomes we deliver
From lowering compliance risk to improving system performance and taking day-to-day SAP strain off your team, we help life sciences companies operate more efficiently, more confidently and more competitively.
Simplify tightly regulated operations from the lab to commercial production.
Improve quality, traceability and audit readiness for every batch, record and release.
Build supply chain resilience with real-time visibility and integrated planning.
Speed up clinical, operational and commercial innovation.
Strengthen collaboration and connectivity with providers, patients, contract development and manufacturing organizations (CDMOs) and other partners.
Apply data, analytics and artificial intelligence (AI) to make predictive, intelligent decisions.
Enter new markets and business models on scalable, compliant SAP foundations.
Meet computer systems validation (CSV) requirements across regulated functions with structured validation documents, test protocols and traceability matrices that stand up to FDA and global regulatory review.
Subindustries we serve
Cell/Gene Therapy
Traceability you can trust from donor to patient
Contract Development and Manufacturing Organizations (CDMO)
Serving many sponsors without compromising data or quality
Donor/Tissue Processing
Connected, compliant operations for life-critical supply chains
Medical Devices
Compliant device lifecycles from design through service
Pharma/Biotech
Built for every stage, from lab to launch
Why SAP for life sciences?
SAP is built for organizations that operate in regulated, high-risk and scientifically complex environments. Its integrated platform helps life sciences companies:
- Protect data integrity and compliance end to end.
- Trace materials, batches and quality events across the global supply chain.
- Standardize processes across R&D, manufacturing, quality and distribution.
- Launch products and enter new markets without reinventing processes.
- Link lab, manufacturing, commercial and financial operations on one platform.
- Support GxP compliance with strong controls, audit trails and electronic signatures.
- Enable predictive planning, intelligent operations and AI-assisted decisions.
With SAP, life sciences companies gain one compliant digital core that meets today’s demands and supports tomorrow’s innovation.
Solutions that support the life sciences value chain
Oraya® matches SAP technologies to the needs of pharmaceutical, biotech and medical device organizations across the entire product lifecycle:
Manufacturing and quality
SAP Digital Manufacturing, SAP QM, SAP EWM, SAP TM, SAP Batch Management, SAP ATTP for serialization compliance and LIMS integrations
Supply chain and distribution
SAP IBP for demand and supply planning, SAP TM and EWM for efficient distribution and SAP Business Network for supplier collaboration
Finance and commercialization
SAP S/4HANA, SAP Revenue Accounting and Reporting, SAP Subscription Billing for device-plus-service models and SAP Analytics Cloud
AI and advanced analytics
AI-assisted forecasting, anomaly detection in manufacturing and natural language insights for research and clinical documentation
Consulting and services for life sciences organizations
We support life sciences companies at every stage of growth:
SAP selection and validation-ready solution design
Right-sized architecture with validation guidance for 21 CFR Part 11, GxP, DSCSA, cGMP and related requirements.
SAP implementation and industry accelerators
Faster deployment with preconfigured life sciences best practices, validated processes and compliant documentation included.
Integration with lab, manufacturing and quality systems
LIMS, MES, QMS and serialization integrations that keep compliant data flowing.
Cloud migration for life sciences IT
A move to SAP cloud solutions with validation-appropriate testing, documentation and security frameworks.
Ongoing SAP AMS and optimization
Support that understands quality, traceability, serialization, batch management and regulated user roles.
User adoption and change enablement for regulated environments
Training, SOP updates and validation-linked change management.
Solution Spotlight
Oraya Life Sciences Suite™ from Oraya®
A validation-ready SAP solution for pharmaceutical, biotech and medical device companies.
Oraya Life Sciences Suite™ is a preconfigured SAP solution shaped by lessons from hundreds of life sciences deployments. It supports regulated operations from end to end, with capabilities that include:
- Preconfigured processes for manufacturing, finance, procurement, order fulfillment, R&D and more
- Built-in support for 21 CFR Part 11, cGMP, DEA, DSCSA and SOX
- Electronic signatures, audit trails, batch traceability and complaint and CAPA management
- Support for regulated sales and sample processing (PDMA)
- Rapid deployment with validation-ready documentation
