Radiant Systems Inc.
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21 CFR Part 11 Validation
Methodology
Compliance Solutions
 
 
 
 
   
   

  21CFR11 Compliance Solutions  


Radiant provides end-to-end business consulting and technical remediation services for 21CFR11 remediation. The Radiant model focuses on value additions through processes and tools. We have a comprehensive 21CFR11 tool-set for training, assessment and remediation approaches. Our methodology can thus help organizations to fit 21CFR11 compliance needs in their overall IT maintenance and development plans.



Radiant, as part of its remediation plan, can propose developing solutions with open electronic formats (like HTML, XML) that can automate collection, storage and sharing of scientific data. Leveraging our wide experience in Data Warehousing, EAI, e-Security and Internet technologies, our solutions will address features like centralized data, single data entry, single sign-on, e-security by using technologies such as Digital certificates, EAI and LDAP.

21CFR11 Compliance Solutions
Radiant embraces the belief that the establishment of a highly disciplined methodology is the cornerstone for success of any computer system validation project. Our methodology is a synthesis of proven techniques that focuses on a proactive task and timeline approach, and incorporates the use of:
 
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Contingency planning.
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Key management databases and reporting.
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Established escalation paths for trouble resolution
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An internal quality process.
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Formal review meetings.
This approach was developed from years of project management experience at industry leading companies and formal project management training. The Radiant methodology provides for the ongoing evaluation of key goals and measurements in conjunction with the establishment of contingency actions and responses as a result of a key event or activity.
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Our validation specialists are highly disciplined individuals who possess both technical and managerial expertise.
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Sr. Validation Specialists have direct ownership of all resources required to design and implement a network system successfully, in contrast to a time consuming matrix of reporting responsibilities.
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All Radiant’s validation projects are divided into multiple phases to increase management control and participation, and ensure successful, cost-effective completion.
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Radiant supports the philosophy that such a structured approach to the network design, analysis, migration, implementation, and operation reduces schedule and technical risk, and greatly enhances the likelihood of our client's total satisfaction.
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In fact, our single most important goal is: CUSTOMER SATISFACTION. In keeping with this, Radiant emphasizes close cooperation, open communication and rapid knowledge transfer.