GxP application delivery
SAP, Oracle, quality, laboratory and reporting changes planned against intended use, product risk and the validation boundary.
Pharmaceuticals & Life Sciences
Deliver SAP, Workday, quality, laboratory, data and reporting changes with risk-based assurance, traceable testing and approved release built into the schedule.
The release date includes the evidence.
A release needs working configuration, approved evidence and a controlled record of the change. Intended use, risk assessment, traceability, deviations and approvals need owners and dates on the same schedule.
Robra puts validation and computer software assurance tasks beside configuration, integration and data work. Named specialists can stay through cutover and stabilization, so the team closing defects understands the decisions recorded during delivery.
Talk to an expertDelivery for regulated systems and the evidence behind them.
Quality and laboratory integration
Interfaces between ERP, QMS, LIMS and data platforms with source-to-target mapping, exception handling and reconciliation.
Computer software assurance
Risk-based test strategy, requirements traceability and objective evidence for production and quality-system software.
Controlled data and reporting
Master-data cleanup, lineage and report logic that quality and operations teams can trace to an approved source.
Change control and release
Impact assessment, test evidence, deviation closure and approvals coordinated before production access or configuration changes.
Post-go-live continuity
Named functional, validation and integration specialists who retain decisions, defects and system history through stabilization.
Connect the system change to its evidence.
We set the intended use and validation boundary before planning tests. Requirements, risks, test results, deviations and approvals remain linked to the configuration or interface they cover, with quality and business owners named in the schedule.
Intended use defines the evidence
Risk and system use determine the traceability, test method and objective evidence required before release.
Change control governs the sequence
Impact assessment, configuration, testing, deviation closure and approval follow the site's controlled path.
Regulated access has lead time
Screening, training, environment access and document-system permissions are planned before specialists start work.
Handover closes the record
The operating team receives approved decisions, test results, open defects, runbooks and the current validated state.
Where life sciences systems have to agree.
The highest-risk work often sits between validated applications, operating processes and the records required to release product.
Batch release to distribution
Quality, laboratory, ERP and warehouse records must agree before finished product can move. One status mismatch can hold inventory after the physical batch is ready.
Serialization through the supply chain
Packaging, serialization, warehouse and partner messages need complete identifiers and exception handling from commissioning through shipment and returns.
Controlled change into operation
Configuration, test evidence, deviations, training and approved procedures must reach the same release decision before users enter the changed system.
Chosen technologies
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Enterprise applications
Workday
HCM, Payroll, Financial Management, Adaptive Planning and Student across delivery, integrations, releases and tenant support.
Explore Workday Enterprise applicationsSAP
S/4HANA, ECC, SuccessFactors, Ariba and BTP across transformation, integration, release and application support.
Explore SAP Enterprise applicationsOracle
Fusion Cloud, E-Business Suite and OCI across ERP, EPM, HCM, supply chain, student, integration and support.
Explore OracleFrequently asked
How can Robra fit into a validated-system transformation?
Robra can add one validation or platform specialist, take responsibility for a workstream, assemble a project team, or provide ongoing support after release. The engagement follows your validation model, quality approvals and internal governance.
What kind of life sciences talent joins the team?
Robra brings experienced functional, integration, data, test and computer software assurance specialists who understand intended use, traceability, deviation closure and controlled release. We match each role to the process and validation boundary in scope.
How does Robra protect continuity through release and stabilization?
Named specialists carry configuration decisions, test history and open deviations from delivery into cutover and stabilization. Minimal turnover means your team spends less time retraining consultants during the phase that needs the most context.
Show us the system and its validation boundary.
Bring the regulated process, target release and open evidence work. We will identify the functional, validation, data and delivery roles the schedule requires.