Comprehensive Validation Services
Ensuring your systems, software, and processes are compliant, reliable, and inspection-ready through our rigorous, risk-based validation framework.
Consult A Validation ExpertCSV & CSA
Risk-based validation strategy aligned with current FDA guidance
IQ / OQ / PQ
Full lifecycle qualification protocols and execution
21 CFR Pt 11
Electronic records & signatures compliance validation
GAMP 5
Software categorization and validation planning
Our 360° Validation Framework
We deliver more than just documentation. By integrating risk management (ICH Q9) and a deep understanding of GAMP 5 principles, we streamline the process, reduce overhead, and build a foundation for sustained compliance.
System Validation (CSV)
End-to-end validation for GxP systems, ensuring strict compliance with 21 CFR Part 11 and data integrity requirements.
AI & Automation
Specialized validation methodologies for AI/ML models and automated systems used in GxP operations.
SaMD & SiMD
Validation of medical device software, including Software as a Medical Device, according to IEC 62304 and FDA guidance.
Cloud Qualification
Qualification of on-premise and cloud infrastructure (AWS, Azure, GCP) to ensure a validated and secure environment.
Process & Equipment
Full lifecycle validation for manufacturing processes and equipment to ensure consistent product performance.
Documentation Lifecycle
Generation of high-quality validation documents: Validation Plans, URS, FRS, IQ, OQ, PQ, and Stage-Gate Summary Reports.
Modernize Your Validation Approach
Partner with Akatalyst to streamline validation timelines and adopt a risk-focused CSA methodology.
Engage Our Team