Comprehensive Validation Services
Ensuring your systems, software, and processes are compliant, reliable, and inspection-ready through our rigorous, risk-based validation framework.
Our 360° Validation Framework
We deliver more than just documentation. Our validation services provide true assurance that your systems are fit for purpose and meet all regulatory requirements. By integrating risk management (ICH Q9) and a deep understanding of GAMP 5 principles, we streamline the validation process, reduce overhead, and build a foundation for sustained compliance.
Core Validation Expertise
Computer System Validation (CSV)
End-to-end validation for all GxP systems, ensuring compliance with 21 CFR Part 11, EU Annex 11, and data integrity requirements.
AI & Automation Validation
Specialized validation methodologies for AI/ML models and automated systems used in GxP decision-making and operations.
Medical Device & SaMD/SiMD Validation
Validation of medical device software, including Software as a Medical Device (SaMD), according to IEC 62304 and FDA guidance.
Infrastructure & Cloud Qualification
Qualification of on-premise servers and cloud infrastructure (IaaS) on platforms like AWS, Azure, and GCP for GxP compliance.
Process & Equipment Validation
Full lifecycle validation for manufacturing processes and equipment to ensure consistent product quality and performance.
Validation Lifecycle Documentation
Generation of high-quality validation documents: Validation Plans, URS, FRS, IQ, OQ, PQ, and Validation Summary Reports.
Ready to Enhance Your Compliance Framework?
Let's build a resilient, efficient, and inspection-ready future for your organization. Schedule a complimentary, no-obligation consultation with our experts to discuss your specific challenges and discover how Akatalyst can be your catalyst for success.
Our Product Suite
Our pre-validated, GxP-compliant software simplifies quality management, with an optional AI layer to unlock next-gen efficiency.
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