21 CFR part 11 compliance: What do you need to know before incorporating an LMS in your business

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21 CFR PART 11 COMPLIANCE
What do you need to know before incorpora?ng an
LMS in your business?
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21 CFR PART 11 COMPLIANCE
WHAT DO YOU NEED TO KNOW BEFORE

• INCORPORATING AN LMS IN YOUR BUSINESS?
• Although having a learning management system for
  your business sounds like a very good idea and
  may be able to provide reforms amongst your
  employees. But what is the most important
  purpose of incorpora?ng an LMS system into your
  business? Is it to increase sales? Or to
  increase produc?vity? No. The most major purpose
  of an LMS system in a business is to make sure
  that your employees are compliant with the rules
  and regula?ons set by the industry that your
  organiza?on needs to follow. 21 CFR compliance
  is one of these regula?ons, but what exactly is
  it?

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21 CFR COMPLIANCE
Although the ?tle of the regula?ons sounds cryp?c
and too complicated, it is actually quite
simple. 21 CFR Part 11 is actually an abbrevia?on
for Part 11 of Title 21 of the Code of Federal
Regula?on. Which is the regulatory law for
electronic signatures and documenta?on in the
Foods And Drugs department more commonly known as
the FDA. But what does that have to do with a
learning management system? Since in the
business industry, all life science and clinical
related industries are to follow the FDA
regula?ons, your LMS system is also under the ?ag
of the FDA. This is only in place to make sure
that the training content, that may include
cri?cal informa?on regarding the organiza?on is
protected from all physical harms and is not
disclosed to any unauthorized par?es.
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WHAT DO YOU NEED TO KNOW TO
MAKE SURE YOUR LMS IS 21 CFR PART 11
COMPLIANT? Restricted data access
Your LMS needs to have well-de?ned access
authen?ca?ons that dictate the level of
informa?on a certain person at a certain level
of the hierarchy is able to view. This not only
helps you keep the security of your business
content but also makes sure that you dont
overload your employees with unnecessary
informa?on.
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User access
Strict protocols are to be put in place to make
sure that no unauthorized individual is able to
access the informa?on present on the learning
management system. Making the content of the
training courses easily accessible to authorized
personnel yet at the same ?me maintaining the
security of the informa?on.
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E-Signatures
This is where the regula?on truly takes e?ect.
An E-signatures are an assortment of numbers,
alphabets, and symbols authorized to represent
an individual. Every single individual, regardless
of having the same hierarchical level, has the
di?erent E-signatures, hence, it is
responsibility of the LMS to verify the
signature before allowing access to the content.
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Audit and tracking
Just like an o?ine system, there needs to be a
proper and intrinsic record of all the changes
that are being made in the content of the LMS to
ensure an audit trail and to ?nd the person
responsible for the changes with relevance to
their E-Signatures.
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Update Tracking
With the pace at which the world is progressing,
informa?on becomes obsolete in the blink of an
eye. As soon as a new program is introduced or a
new so?ware has been implemented, everything you
have known to that point becomes obsolete. This
is why it is crucial for your system to
constantly check for any relevant updates that
may be required and keep track of all previously
made updates.
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Repor?ng
The repor?ng authority of all LMS systems under
the 21 CFR part 11 compliance is s?ll the FDA and
they can demand an updated report at any
moments no?ce. Make sure that all informa?on
and records are always maintained to the most
recent changes and that your system is ready to
generate a proper and complete report, whenever
it is demanded of it. Well there you have it,
this is what your LMS needs to have to make sure
that it is compliant with the 21 CFR part 11
compliance. Is your LMS up to par? Or are you
missing out on something and need to work on it?
We hope that this informa?on was useful for you.
Swing by our other blogs for more similar
ar?cles regarding performance management and
learning management.