Key Services
Validation as a Service
Validation and Qualification (V&Q) are essential pillars of a successful digital transformation strategy, ensuring compliance and operational excellence.
Validation & Qualification Segments
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 span the entire product lifecycle—from initial development through to final deployment and ongoing operations—ensuring compliance at every stage of your value chain.
Avoiding the Cost of Poor Validation
In the last three years alone, approximately 200 FDA warning letters highlighted validation and qualification deficiencies. Our proactive approach mitigates these risks, safeguarding your organization's reputation and regulatory compliance status.
Life Sciences Project Validation
Connexo offers end-to-end validation support for automation projects across life sciences, ensuring that all regulatory and operational requirements are fully met throughout implementation.
System Development Lifecycle (SDLC)
Our validation services adhere to the ISPE GAMP® 5 guidelines, following a structured System Development Lifecycle (SDLC) methodology. This approach ensures all user requirements are thoroughly captured, implemented, validated, and documented.
Risk-Based Validation Methodology
We utilize the GAMP® 5 "V-Model", a risk-based methodology tailored to GxP computerized systems compliance, ensuring validation activities are efficiently targeted and appropriately scaled to risk.
System Implementation Services
Connexo supports clients from project initiation through full-scale implementation and post-deployment support, ensuring 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, ensuring 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
Our comprehensive laboratory validation services ensure full compliance across laboratory environments, from standalone systems to complex integrated laboratory solutions, supporting your ongoing strategic validation and regulatory requirements.