Expert Services for Quality Excellence

Software Implementation

Regller implementation services are designed to move organizations from configuration to value quickly, while maintaining regulatory integrity. Implementation scope includes:

• Platform configuration aligned to your organization’s structure (Company, Site, Function, Process, System)
• Role-based access control (RBAC) and security model setup
• Configuration of QMM assessments, scoring models, and dashboards
• Setup of Site Qualification, Validation Automation, and PeoplePlace modules
• Integration planning with existing systems (eQMS, ERP, MES, LIMS)
• Data migration and historical evidence onboarding
• User onboarding, training, and adoption support

Our Approach:

• Risk-based configuration (not one-size-fits-all)
• Phased rollout (pilot to scale)
• Regulator-ready documentation from day one

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Computer System Validation

Regller provides end-to-end validation services for GxP-impacting systems, whether on-premise or cloud-based. Services include:

• GxP impact and risk assessment
• Validation strategy definition (CSV vs CSA-based)
• URS, FS, DS creation and review
• IQ / OQ / PQ planning and execution
• Risk-based test case design
• Traceability matrix creation
• Data integrity and Part 11 assessments
• Validation of Regller and third-party systems
• Support for vendor-supplied documentation leverage

CSA-Aligned Philosophy:

• Critical thinking over excessive documentation
• Testing what matters most
• Leveraging supplier documentation appropriately
• Aligning validation effort with patient and product risk

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GxP Audit and Inspection Readiness

Regller delivers risk-based GxP audit services across pharmaceutical, biotech, medical device, and food operations. Audit services include:

• Internal GMP/GDP/GCP audits
• Mock FDA / EMA inspections
• Site and system readiness assessments
• Supplier and contract manufacturer audits
• Audit program design and execution
• Observation categorization and risk scoring
• CAPA definition and effectiveness verification

What Makes Regller Different:

• Audits aligned to FDA QMM practice areas, not just checklists
• Focus on systemic maturity, not isolated findings
• Digital capture of audit evidence and trends in Regller

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Design Thinking for Quality

Many quality processes fail not because of intent, but because they are overly complex, don’t reflect how people actually work, or are designed around documents rather than decisions. Regller applies design thinking principles to regulated processes without compromising compliance.

What We Do:

• Stakeholder and user journey mapping (QA, Manufacturing, IT, Engineering)
• Identification of pain points, bottlenecks, and failure modes
• Redesign of SOPs, workflows, and decision models
• Prototyping of digital workflows in Regller
• Change management and adoption planning

Use Cases:

• Redesigning deviation and CAPA workflows
• Simplifying validation and qualification processes
• Improving management review effectiveness
• Designing scalable global quality models