Validation Solutions
At Moriah Engineering Solutions, Inc., we specialize in providing comprehensive validation services to ensure that automated systems and processes comply with regulatory requirements. Our goal is to help clients maintain data integrity and operational reliability while meeting industry standards.
Our Validation Expertise Includes:
Computer System Validation (CSV): Comprehensive validation services to ensure that automated systems meet regulatory compliance, focusing on data integrity and system accuracy.
Process Validation: Verifying that manufacturing processes consistently produce products that meet predetermined specifications and quality standards.
Equipment Qualification (IQ/OQ/PQ): Ensuring that equipment and systems function as intended through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Cleaning Validation: Confirming that cleaning processes effectively remove residues to acceptable levels to prevent contamination.
Data Integrity Assessment: Identifying vulnerabilities in data management systems and implementing corrective actions.
Risk Assessment and Mitigation: Evaluating potential validation risks and establishing proactive solutions.
Documentation and Reporting: Preparing comprehensive validation protocols, test scripts, and final reports to meet audit requirements.
Regulatory Compliance Support: Aligning validation processes with FDA, EMA, and other regulatory body guidelines.
Our validation services ensure that your manufacturing systems are reliable, compliant, and optimized for performance, helping you achieve consistent quality and regulatory adherence.