Radiant provides validation services to the pharmaceutical, biotechnology and medical devices industries that are adaptable to fit each client's needs and procedures. Radiant supports customers in Computer System Verification and Validation:

Capability Relating To 21 CFR Part 11 Validation
	Why Computer System Validation?
	Companies strive to create goals, processes, culture, management, and incentives that build infrastructure. Computer Systems (software) are a dominant and increasing part of business infrastructure. Computer System Validation is process validation and has the following benefits:
	. Provides documentation required by FDA, other regulatory agencies, and your customers. . Maximizes the value of the computer system and the employees that use it. . Reduces labor costs by increasing employee efficiency and effectiveness. . Enhances project management to ensure projects are implemented on schedule and on budget. . Saves money by discovering defects early, before failures occur in production. . Reduces risk. Legal liability, not regulatory, is often the most important reason to perform validation. Software and process defects increase with software complexity. Having the evidence that computer systems are correct for their purpose and operating properly represents a good business practice . Promotes continual process improvement. Software is constantly evolving to keep up with the increasingly complex needs of the people that use it. Therefore, validation is an ongoing necessity.
	Compliance And Remediation Strategies
	Radiant provides validation services to the pharmaceutical, biotechnology and medical devices industries that are adaptable to fit each client's needs and procedures. Radiant supports customers in the following areas of Computer System Verification and Validation:
	. Validation Project Management . Preparation of Validation Summary Reports . Preparation of Validation Plans and/or Protocols . Document Validation Deliverables . Evaluation/Assessment of Validation Documents (Gap Analysis) . System Design Documentation (URS/FS/DS, etc.) . Validation Test Script and Test Data Creation . Evaluation and/or Development of SOPs . Audit Reporting of Computer System (hardware/software) . Change Control and Corrective Action Follow-up . Comprehensive Training Services
	Services
	In addition to our Computer Systems Validation and Verification expertise, Radiant can provide provable 21 CFR Part 11 Services that address the following areas:
	. Develop 21 CFR Part 11 Project Plan . Develop Gap Analysis, Sops, Policies, Requirements and Specifications Checklist . Develop Part 11 Strategies for Open/Closed Systems . Develop Systems Inventory and Assessment Checklist Based on Business and Regulatory Requirements . Custom Design 21 CFR Part 11 System Integration Solution that will Address Data Integrity, Audit Trails, Security and Electronic Signatures/Electronic Records . Develop a Remediation Action Plan to Address each Non-Compliance System . Execute the Remediation Action Plan . Provide Customized Comprehensive Training . Radiant presents the results in a customized Certification Book that provides evidence that the validation has been accomplished to regulatory agencies, such as the FDA
	Expertise and Approach
	Radiant’s Validation Services follow a lifecycle approach towards validation, thus ensuring compliance with basic software quality principles of independence of review, data integrity and security, and system reliability. Designed by personnel trained in FDA regulations and including an efficient Quality Management System, our methodology addresses prominent validation activities such as:
	. Comprehensive inventories, including operating systems software, and client PC configurations . Change control and error reporting procedures . Defect prevention plan . IT personnel training records . Software supplier records . Software Version Control procedures . Archiving/backup procedures and responsibilities . Software Life cycle deliverables like requirements/design/testing documents . Disaster recovery procedures . Computer System Security procedures . Computer System User Administration