Computing Infrastructure Validation

Risk Assessment

Prospective / Retrospective Validation

SOP Development

Audit Services

With a depth of experience in all facets of the system life cycle we are able to assist our clients to reach their goal of optimal performance.

Rudraya has become a recognized leader in providing computer system validation and regulatory compliance services to the Life Sciences Industry. As a full-service company we have been helping our clients 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 our clients. 

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, and many more.

Computer Systems Validation

  • 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

SOP Development

  • 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

Audit Services, Training, and Regulations

  • Inspection Readiness

  • Vendor Audits

  • Audit Process Development

  • Computer System Validation

  • SOP Development

  • Audit Services

  • HIPPA

  • 21 CFR Part 11: Electronic Records/Signatures

  • GxP

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Booth #538

April 21st to 23rd, 2020
Boston, MA

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June 9th to 12th, 2020

Ljubljana, Slovenia

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October 4th - 7th, 2020

Aurora, CO

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