System Validation
Connexo’s Computerized System Validation (CSV) consulting services help demonstrate that systems meet defined user requirements and are fit for their intended use. We assess features such as data security, audit trails, and electronic signatures according to their risk and applicable requirements. Our services range from support for specific validation activities to full-scope projects, with documented evidence to support review.
Key Services
Validation as a Service
Validation and Qualification (V&Q) are essential pillars of a successful digital transformation strategy, supporting compliance and operational excellence.
Validation and Qualification Across the Lifecycle
Our approach emphasizes Quality by Design, making validation and qualification integral parts of your overall product lifecycle management strategy.
Validation Requirements: Regulatory Compliance
We provide objective evidence through rigorous testing and documentation to confirm that software meets defined user requirements and consistently performs as intended, fully aligning with regulatory guidelines.
Comprehensive Validation Service
Our validation and qualification services cover development, deployment, and ongoing operation, helping teams maintain evidence that their systems remain fit for intended use.
Avoiding the Cost of Poor Validation
Validation and qualification deficiencies can lead to regulatory findings and costly remediation. Our proactive approach mitigates these risks, safeguarding your organization's reputation and regulatory compliance status.
Life Sciences Project Validation
Connexo supports validation of life sciences automation projects from planning through implementation, helping teams define requirements, assess risks, and document the evidence needed for review.
System Development Lifecycle (SDLC)
We follow ISPE GAMP® 5 principles within a structured system development lifecycle. Requirements, risk assessments, implementation, testing, and documentation are coordinated to support traceability and review.
Risk-Based Validation Methodology
We use a V-model to link requirements with verification within our risk-based approach aligned with ISPE GAMP® 5. Validation activities are scaled to intended use, system complexity, and risk.
System Implementation Services
Connexo supports clients from project initiation through full-scale implementation and post-deployment support, supporting smooth transitions and sustained compliance across all system phases.
ERP Software Validation
Our validation experts guide your ERP software projects from planning through go-live operations, supporting continuous adherence to regulatory demands and facilitating successful software deployments.
Manufacturing System Validation
We deliver scalable, pragmatic lifecycle validation solutions to streamline your manufacturing processes, save time, increase productivity, and maintain regulatory compliance.
Laboratory System Validation
We validate laboratory systems, from standalone applications to integrated solutions, against their intended use and applicable requirements. Documented assessments and testing support your laboratory’s validation and compliance activities.