Computer systems have revolutionized the way that we as everyday people set about our day. Whether it's a smartphone in our pocket with the newest apps, a tablet device in our lab or a personal computer in our office, using technology has, and can still have a positive impact on productivity and efficiency – that’s just a fact.
With the way that we consume information today and therefore
the non-flinching adoption of latest devices and technology, it just seems
natural that we use these systems to manage records electronically in situ of
paper records. because the phrase goes, “with world power , comes great
responsibility.” an equivalent are often said for computerized systems in
regulated industries.
Let's take a deeper check out the 21 CFR Part 11 Regulations
from the FDA, and why they're so important in today’s bioscience environment.
What is 21 CFR Part 11?
21 CFR Part 11 may be a section within the Code of Federal
Regulations (CFR) that sets forth the us Food and Drug Administration’s (FDA)
guidelines on using electronic records and electronic signatures. Each title of
the CFR addresses a special regulated area, 21 CFR relates to Pharmaceuticals
and Medical Devices and Part 11 being applicable to electronic records and
electronic signatures.
At a high level, Part 11 may be a law that ensures that
companies and organizations implement good business practices by defining the
standards under which electronic records and signatures are considered to be
accurate, authentic, trustworthy, reliable, confidential, and like paper
records and handwritten signatures on paper. Part 11 essentially allows any
paper records to get replaced by an electronic record, and allows any
handwritten signature to get replaced by an electronic one.
Here are the definitions…
Electronic Record: Any combination of text, graphics, data,
audio, or pictorial information represented in digital form that's created,
modified, maintained, archived, retrieved or distributed by a computer.
Electronic Signature: A compilation of any symbol(s)
executed to be the legally binding equivalent of an individual’s handwritten
signature.
Handwritten Signature: The scripted name or legal mark of a
private handwritten by that individual and executed or adopted with this
intention to authenticate an article during a permanent form.
Digital Signature: An electronic signature based upon
cryptographic methods of originator authentication, computed by employing a set
of rules and a group of parameters such the identity of the signer and
therefore the integrity of the info are often verified.
A brief history of 21 CFR Part 11
In early 1991, key groups who operated within the
pharmaceutical industry met the FDA to work out how the industry would affect
electronic record keeping systems that fell within the age old GMP regulations.
Over subsequent few years these groups alongside the FDA
began to build out the first versions of the principles we are governed by
today, with the ultimate rule becoming effective on August 20th, 1997.
From the year 2000, the FDA stated that alongside the
released criteria, they might consider electronic records to hold an equivalent
compliance requirements as paper records, and including electronic signatures
as the same to the normal wet ink handwritten signatures.
From the year 2000 to now (2014), the FDA has released
variety of guidance papers in response to the changing landscape in an attempt
to clarify the rule and the way it should be interpreted. Here’s a brief
chronological history:
1991 – Project Launched
1992 – Advanced Notice
·
1994 – Proposed Rule
·
1997 - Final Rule
·
2000 – Electronic Records
·
1999 – Computerized Systems
Used in Clinical Trials (CSUCT)
·
2003 – “Scope and
Application” Guidance
·
2004 – Draft Computerized
Systems Used in Clinical Trials Guidance
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