AXON Research

"From Thought to Action"

Building Solutions to Information Challenges of the 21st Century

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CSV Compliance
Software and Databases
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Quality and Process

CSV Compliance


Computers systems offer huge advantages, but require proper management to provide quality data and products on a regular basis.


The Quality Systems approach and 21CFR Part 11 are two elements for meeting the necessary levels of reliability while making best advantage of the latest computer technologies.


AXON Research is active in system validation,  and in the assessment and remediation of computer systems to meet regulatory compliance requirements.



Computers allow us to:


capture and organize data efficiently


perform repeatable analyses of large data sets


have all the advantages of paper and electronic systems simultaneously!

(if proper care is taken)


... and make more mistakes faster!
(if proper care is not taken)

Persons using the data
from computerized systems…

...should have confidence that the data are no less reliable than data in paper form.”


- April 1999
  FDA Guidance for Industry
  Computerized Systems 
  Used in Clinical Trials



The ALCOA Principle


Data from electronic systems must be:


Attributable - to a specific

individual with rights and responsibility for the data




Contemporaneous - captured at the time of observation


Original - first entry into durable media




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