AXON - 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

Legible

Contemporaneous - captured at the time of observation

Original - first entry into durable media

Accurate

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AXON Research

"From Thought to Action"

Building Solutions to Information Challenges of the 21st Century