Life Sciences: Pharma/Biotech

Your infrastructure can’t wait for approval

Pharmaceutical and biotech companies face a problem few industries share: the systems and processes a commercial-stage company needs have to exist before the company gets there. Regulatory inspections, investor due diligence, contract manufacturing organization (CMO) partnerships and launch timelines won’t pause while infrastructure catches up. Building too late, or building the wrong foundation too early, can push back launches, create compliance exposure and leave growth unrealized.

Oraya^® works with pharma and biotech organizations at every point along the development path. We bring the SAP expertise and life sciences knowledge to put the right foundation in place at the right time: scalable enough to grow with you, compliant enough for regulators and lean enough for where you are today.

Spotlight

The Lumen story

When Oraya^® first began working with Lumen Biotherapeutics, it was a small research-stage biotech. Years later, when demand for its lead therapy surged far beyond anything in the plan, the SAP foundation was already in place to support that growth.

“We never planned for that kind of growth, but the platform they built for us was ready for it the day we needed it.” – Priya Raman, Lumen Biotherapeutics

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Understand your stage and plan for the next one

SAP is never a one-size-fits-all deployment. The right approach depends on where you are in your journey and where you plan to go. Here’s how we look at it:

Precommercial stage

Discovery and preclinical: Plant the seed. This is the ideal moment to set up data and document management that won’t have to be rebuilt later.
Clinical trials: Lay the groundwork. Quality, compliance and supply chain infrastructure should take shape now, well before a regulatory submission is in sight.
Regulatory submission: Show you’re ready. Audit trails, electronic signatures, batch records and validated processes must be in place, and gaps in your SAP foundation become visible and expensive here.
Launch readiness: Get ready to scale. Commercial manufacturing, distribution and serialization need to be live before launch, not configured along the way.

Commercial stage

Launch: Move at speed. Supply chain visibility, order management and serialization compliance have to run at full capacity from the first day.
Commercial manufacturing: Scale with confidence. Batch management, quality events, collaboration with contract development and manufacturing and contract research organizations (CDMOs/CROs), and live operational visibility become a competitive edge.
Post-market monitoring: Sustain and improve. Complaint management, corrective and preventive action (CAPA), pharmacovigilance data integration and ongoing regulatory reporting all depend on a durable, connected SAP foundation.

Outcomes we deliver

Establish a compliant, audit-ready SAP foundation before regulators, investors or partners ask to see it.

Scale manufacturing, supply chain and quality operations without rebuilding systems at every growth stage.

Speed up regulatory submissions with validated processes, electronic signatures and complete batch traceability.

Gain real-time visibility across CMO/CDMO and third-party logistics (3PL) partners without putting data integrity at risk.

Launch and ship commercial products with serialization, track-and-trace and order management ready from day one.

Manage post-market obligations, including complaints, CAPAs and regulatory reporting, on the same integrated platform.

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 pharma/biotech

Oraya^® supports every SAP Cloud ERP deployment model, helping regulated clients choose the architecture that suits their compliance posture, IT strategy and timeline. SAP’s platform is designed for the specific compliance and operational demands of regulated pharmaceutical and biotech environments:

Validated processes and electronic records that satisfy 21 CFR Part 11, cGMP and GxP requirements at every stage
Data integrity controls aligned with ALCOA+ principles (attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available), a continuing focus for regulators worldwide
Integrated quality management for deviations, CAPAs, change control and complaint handling
SAP Batch Release Hub to automate batch disposition, release workflows and electronic signatures, shortening cycle times, reducing manual error and keeping a complete release audit trail

Customer Success Stories

Lumen Biotherapeutics

Life Sciences, Pharma and Biotech

Northgate Healthcare Packaging

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