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Hello, today at LifeConEx we're going to talk about
the 21 CFR regulation, 21 CFR 11 is shorthand for
title 21 of the Code of Federal Regulations, Part 11
and it's all about data integrity and system security
It is an FDA requirement to make
electronic records and signatures "as valid"
as hard copy paper documents.
It was first introduced in 1997 in an effort to move from paper to e-filing in the 21st century,
to prevent fraud and to make audit trails fast and accurate.
The FDA recognized
that it would be difficult to track who is responsible for electronic documents,
unless a comprehensive verification system was put in place.
Electronic records are verified using a user name, date and time, time zone, and the purpose.
time I'm so the perks the doc
The FDA requires standard security protocols be used to ensure the integrity of stored records;
including a unique username and password, SSL encryption,
expiring passwords, and a data backup system.
However if paper copies are being kept,
electronic records don't need to meet 21CFR11 requirements.
LifeConEx gives clients the ability to manage their
shipping portfolio online through life track which keeps
electronic copies of all SOP documentation including
a manifest of every box, temperature its stored at and loaded to,
tracking numbers, dates and times of arrival, departure,
and re-icing, as well as information regarding delays
and what measures have been taken to prevent excursions. This gives our customers both
an eye-in-the-sky and feet-on-the-ground approach to monitoring their shipments
in near-real-time. LifeTrack lets customers LifeConEx It
and live their life.