Large and growing enterprises are facing a challenge to their core missions of developing and producing new products including food, therapeutic pharmaceuticals, medical devices, cosmetics or other public health enhancing items. This challenge is the complexity of complying with government regulations designed to protect public health and safety. The most notable of these is Title 21 of the Code of Federal Regulations governing Electronic Records and Electronic Signatures (21CFR11). To ensure enforcement of these regulations enterprises are responding with a wide variety of initiatives, both within individual organizations and across industry sectors. Radiant understands that achieving Part 11 compliance is a challenging issue that must be addressed at various levels of your organization.

Methodology Details
Radiant's multi-step Part 11 Implementation Process is designed to capture the required phases to properly implement Part 11 compliant systems.
	Instill CFR Part II Awareness
	A General awareness is to be given to foster company-wide support for compliance, to make personnel available for appropriate responsibilities
	Develop Standard Operating Procedures
	. Radiant will assist in identifying all SOPs currently in place that relate to a company’s computer systems and preparing the SOPs . Radiant would assist in establishing a validation program through a series of SOPs. We would provide a sample industry standard validation practices that can serve as baseline documents and assist in modifying these baseline procedures into detailed practices and procedures that are functional for their specific company
	Perform GAP Analysis
	It is necessary to conduct a Gap analysis once all the policy statements and SOPs are in place. Each system will be physically tested according to the requirements. Any computer system that does not meet one or more of the requirements of the validation program must be considered a gap and requires remediation. Compliance only exists when there are no gaps. Each system is evaluated for various assessment areas.
	Take Inventory
	Radiant will assist in Carrying out a system inventory of all new and legacy systems
	System Lifecycle which includes development
	Requirement gathering, Design implementations, Testing & Commissioning for GxP compliant applications
	. Requirements Phase: A requirements definition is written for each system to identify specific operating and use requirements for the computer system. They will be used as the basis of the design phase. The testing phase will assure that all requirements elements have been accounted for in the design phase. . Design Phase: The design phase follows the requirements phase. The purpose is to assure that each element defined in the requirements phase is addressed. . Implementation Phase: During the implementation phase all elements of the system, as defined in the design phase, are brought together. The product is a fully functioning piece of software that meets the original requirements. . Testing Phase: During this phase, the computer system is tested against specifications in the requirements definition phase. Tests are structured to provide traceability to both design and requirements documentation. Testing has three elements > Installation Testing e.g., environment, power, plumbing > Operational Testing e.g., each individual function > Performance Testing e.g., maximum users, maximum data flow . Decommissioning / Commissioning phase: Starting over can be a new version/upgrade of currently used software or it can be replacement of the current system. In any case, all data is archived and/or migrated to the new system. The old system is then removed from operation and a full audit trail of the dates and reasons for decommissioning is kept . Change Control: The final SOP in the validation program defines how changes to a validated computer system are managed and documented. Changes are tested on a non-production system before they are implemented on the target system. The computer systems validation specialist must evaluate the impact of the change on the validation system. If it is significant change, revalidation may be required. Minor changes may require only documentation