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Rudraya has become a recognized leader in providing computer system validation and regulatory compliance services to Life Sciences Industry. As a full-service company we have been helping life science companies become compliant with IT-related regulations and guidelines.
Our knowledge of current regulatory expectations and international standards, combined with our technology expertise, enable us to understand the challenges and issues faced by Life Sciences companies. We help our clients achieve their business goals and objectives while maintaining regulatory compliance and a state of control across all operational areas within the enterprise. With a depth of expertise in all facets of the system life cycle we are able to assist our clients to reach their goal of Optimal Performance.
Our team has expertise in validating computer systems used in Clinical Trials Data Management, Clinical Trials Supply Chain Management, Process Control Computer Systems, Adverse Event Reporting Systems, Laboratory Equipment's (HPLC, FTIR, etc.), Laboratory Information Management Systems, Analytical Lab Data Management, Toxicology Data Management, Clinical Pharmacology Data Management, Drug Product Manufacturing (Sterile/Non-sterile), API Manufacturing, CAPA Systems and Interactive Voice/Web Response Systems.
Our Validation Expertise
|Computer Systems Validation||SOP Development||Audit Services|
Prospective / Retrospective Validation
User and Functional Specifications
Unit and Integration Testing
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
User Acceptance Testing
Test Summary Report
Validation Summary Report
|Software Development Lifecycle
Change Control Process
Backup, Archive and Restore Management
Access Control and Security Management
Audit Process Development
Computer System Validation
21 CFR Part 11: Electronic Records/Signatures