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21CFR11 Compliance Solutions |
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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.
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| 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. |
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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.
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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.
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