Computer System Validation
Maximizing value with risk-based Computerized System Validation
We understand the current challenges and pitfalls in the traditional approach to validation which includes duplication of work, time and cost inefficiencies, regulatory compliance confusion, decentralized processes, and integrity issues with manual data entry. Let us guide you, adopting a streamlined and risk-based approach backed by a paperless Validation Life Cycle Management System (VLMS), that addresses these issues head-on, ensuring compliance and efficiency every step of the way.
We begin by assessing the system's intended use and associated risks, ensuring product safety. Leveraging supplier documentation, we identify previous validation efforts to streamline the process. Our risk-based approach enhances testing efficiency by focusing on critical modules and functionality. For low and medium-risk scenarios, we employ unscripted, or minimum testing methodologies, providing a cost-efficient and time-saving solution without compromising precision. Further, we are flexible in our approach and can adapt our methodology to suit your business processes.
Our Validation Services include:
Validation as a Service (VaaS)
Software Validation
End-to-End validation for Process Automation (MES, PLC, SCADA), ERP, DMS, QMS, BMS, EMS and Web Based Systems.
System Update and Migration Support
System update and data migration from legacy systems to ensure accurate data transfer.
Validation Consulting
Legacy System
Assessment of legacy systems and remediation planning for non-compliant systems.
Audit Readiness with DG-DIRA
Inspection readiness check with focus on Data Governance and Data Integrity (DG-DIRA)
Framework Readiness
Support in defining organization level CSV framework including SOPs, templates, and training
With engagement models to best suit your needs, we provide global resourcing, specific project support, and can serve as a strategic validation partner.
Resourcing
- Need based
- Quick capacity augmentation
- Extremely flexible
System/Project Specific
- Specific to project
- Use own SOPs or Navitas Life Sciences’
- Final handover post completion
- Bespoke solution
Strategic Validation Partner
- Long term engagement
- Comprehensive services
- Prospective and retrospective validation
- Maintenance of existing systems
- Own SOPs and frameworks
- Offshore/onshore model
Why Navitas Life Sciences?
To date we have successfully delivered 80+ CSV projects
Validated Track Record
Highly Skilled Team
Vendor Independence
Proven Framework
Cost Effective Solution
Our approach is grounded in a standard V model, employing a lean risk-based methodology. Backed by a proven framework and supported by customizable templates, protocols, and procedures, our approach offers adaptability for both paper-based and paperless systems.
We focus on three core pillars, People, Process, and Platform. By emphasizing these elements, we deliver a fresh, value-adding approach to CSV. Whether you are in need of Validation Consulting or Validation as a Service (VaaS), we have you covered.