Computing Infrastructure Validation

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
Risk Assessment
Prospective / Retrospective Validation
Validation Plan
Remediation Plan
User and Functional Specifications
Design Specifications
Test Plan
Unit and Integration Testing
Traceability Matrix
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
User Acceptance Testing
Test Summary Report
Validation Summary Report
Software Development Lifecycle
Validation Lifecycle
Change Control Process
Business Continuity
Disaster Recovery
Backup, Archive and Restore Management
Access Control and Security Management
Error Reporting
Configuration Management
Vendor Audit
Quality Investigations
Regulatory Inspection
Inspection Readiness
Vendor Audits
Audit Process Development

Training
Computer System Validation
SOP Development
Audit Services

Regulations
HIPPA
21 CFR Part 11: Electronic Records/Signatures
GxP

Our Expertise

 
 
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Affiliation and Accreditation

Rudraya Support

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