Our Services
End-to-end compliance and validation solutions for the modern life sciences enterprise
Computer System Validation (CSV)
Full lifecycle validation services across enterprise platforms. From validation planning through IQ/OQ/PQ execution to summary reporting. Risk-based approach aligned with GAMP 5 and ICH Q9.
Key Deliverables
- Validation Master Plans and System-Specific Validation Plans
- User/Functional/Design Requirement Specifications (URS/FRS/DS)
- IQ/OQ/PQ Protocols and Execution
- Traceability Matrices and Validation Summary Reports
- Periodic Review and Change Control Assessments
Computer Software Assurance (CSA)
The FDA's modern, risk-based framework moving beyond traditional CSV. CSA reduces unnecessary documentation burden while increasing assurance through critical thinking, unscripted testing, and risk-informed decision making.
Key Deliverables
- CSA Risk Assessments and Intended Use Statements
- Critical Thinking-Based Test Strategies
- Unscripted and Scripted Testing (risk-proportionate)
- Assurance Activities and Evidence Packages
- CSA Transition Roadmaps (CSV to CSA migration)
AI Validation & Intelligent Compliance
Validation and governance of AI/ML systems in GxP environments. As pharma adopts machine learning for manufacturing, quality, and clinical operations, Rynovate ensures these systems meet regulatory expectations for transparency, reproducibility, and lifecycle governance.
Key Deliverables
- AI/ML Model Validation Frameworks
- Algorithmic Transparency and Bias Assessments
- Model Lifecycle Governance (training, monitoring, retraining)
- AI Risk Categorization and Impact Analysis
- Regulatory Alignment: FDA AI/ML Action Plan, EMA Reflection Paper, ISPE GAMP AI Annex
Audit & Remediation Services
Pre-inspection readiness and compliance gap remediation. We prepare your systems and processes for regulatory scrutiny from FDA, EMA, MHRA, WHO, and other global agencies.
Key Deliverables
- Pre-Inspection Readiness Assessments
- Gap Analysis and Remediation Plans
- 21 CFR Part 11 / EU Annex 11 Compliance Audits
- Data Integrity Audits (ALCOA+ Framework)
- CAPA Management and Effectiveness Monitoring
- Supplier and Vendor Qualification Audits
Project & Program Management
End-to-end compliance project delivery for system implementations, upgrades, migrations, and transformations. We bring PMO discipline to validation programs so they ship on time and on scope.
Key Deliverables
- Compliance PMO Setup and Governance Frameworks
- System Implementation Project Management
- Enterprise Migrations and Upgrade Programs
- Vendor Selection and Qualification Management
- Regulatory Submission Support Programs
Skilled Resource Solutions
On-demand access to compliance professionals who embed directly into your teams. From individual contributors to full validation teams, flexibly engaged to match your program needs.
Contract Staffing
Individual professionals for specific roles and durations
Managed Services
Dedicated teams with Rynovate-managed delivery
Center of Excellence
Build and operate a validation CoE within your organization
Roles We Staff
- Validation Engineers and CSV/CSA Analysts
- Quality Assurance Specialists
- Regulatory Affairs Professionals
- Pharmacovigilance Specialists
- Clinical Data Managers
- Manufacturing IT and Automation Engineers
Training & Capability Building
Comprehensive training programs for pharma teams and individuals. From GxP fundamentals to advanced system-specific deep dives, we build the compliance expertise your organization needs to operate confidently in regulated environments.
Corporate Programs
Customized training for teams aligned to your SOPs and systems
Individual Training
One-on-one and cohort-based courses for career development
Workshops & Bootcamps
Intensive hands-on sessions for rapid upskilling
Training Domains
- GxP Fundamentals and Regulatory Awareness (FDA, EMA, WHO)
- Computer System Validation (CSV) and Computer Software Assurance (CSA)
- Data Integrity and ALCOA+ Principles
- 21 CFR Part 11 and EU Annex 11 Compliance
- GAMP 5 Risk-Based Approach to Validation
- AI/ML Validation in GxP Environments
- System-Specific Training: SAP, Veeva Vault, TrackWise, LabWare, and more