In this blog post I plan to take a look at
the FDA 21 CFR Part 11 Regulations (what is it?, term definitions, why do we need it?),
and resources available to comply with these requirements using the Wonderware Software.
What is 21 CFR Part 11?
The 21 CFR Part 11 regulations from the Food
and Drug Administration (FDA) sets forth the criteria under which the agency
considers electronic records and electronic signatures to be trustworthy,
reliable, and generally equivalent to paper records and handwritten signatures
executed on paper.
Term definitions
Electronic Record: Any blend of content: text, graphics, data, audio, or pictorial information
represented in digital form that is created, modified, maintained, archived,
retrieved or distributed by a computer.
Electronic Signature: A gathering of any
symbol(s) executed to be the lawfully tying likeness an individual's manually
written mark executed to be the legally binding
equivalent of an individual’s handwritten signature.
Handwritten Signature: The scripted name or
legitimate characteristic of an individual written by hand by that individual
and executed or embraced with the present aim to verify a writing in a permanent
form.
Digital Signature: An electronic mark
based upon cryptographic techniques for originator verification, figured by
utilizing an arrangement of standards and an arrangement of parameters such
that the character of the underwriter and the respectability of the information
can be verified.
Why do we need it?
By introducing the 21 CFR Part 11 control, the FDA have basically
empowered the FDA directed industries to streamline business forms, diminish
turnaround time and costs, all by building up standard criteria for the
utilization of electronic records and signatures. Witout this rule, we would be
unable to manage records and other content electronically, significantly
increasing the risk of human errors, increasing operational costs and
increasing time-to-market for products.
What you need to think about if you are tasked with complying with 21 CFR
Part 11
According
to Montrium, there are three main areas in which
FDA-regulated organizations must look at as primary areas of focus when working
to comply with the 21 CFR Part 11:
Features of Your Software System - In
accordance with 21 CFR Part 11 there is a range of characteristics that you are
required to have in place when implementing a software application to manage electronic records and processes. For
example: Audit trail functionality, electronic signatures, security and data
integrity, records retention and file formats are to name but a few.
Standard Operating
Procedures - As
with all regulated industries, the companies that operate within them use
Standard Operating Procedures (SOP’s) to govern and describe how they are to do
things.
System Validation –
When implementing an electronic system for the use in regulated activities, you
have to ensure that you document that the electronic system is fit for its
intended use. In other words, demonstrate that your system does what it should
do. You must also have controls in place that allow you to identify when the
system doesn’t function as per its intended use. Here you should be utilizing
your SOP’s and industry best practices (such as the Wonderware
System Platform 2014 R2 with InTouch 2014 R2 21 CFR Part 11 Deployment Guide)
to facilitate the validation process.
Resources available
from Schneider Electric Software to comply with the 21 CFR Part 11
This 21 CFR Part 11 Deployment Guide for Wonderware System
Platform™ 2014 R2 with InTouch 2014 R2 offers information on Wonderware System
Platform, InTouch, and Wonderware Historian features relevant to the 21 CFR
Part 11 requirements of the U.S. Food and Drug Administration (FDA).
While not directly subject to regulation under 21 CFR Part
11, Wonderware System Platform, InTouch, and Wonderware Historian products
incorporate features and functionality designed to facilitate the development
of applications for use in FDA-regulated industries. Accordingly, Schneider Electric
Software has made available this document to
provide customers with a set of "best practices" in regards to
certain Wonderware products and the 21 CFR Part 11 requirements.
Best practices suggested in this deployment guide, in
conjunction with properly designed and implemented external procedural
controls, should reduce the cost of development, validation, and
re-qualification of applications.
Wonderware System Platform, InTouch, Historian, and
procedural controls can be used to implement systems that comply with the FDA's
21 CFR Part 11 regulation.
Related resources
Reference:
The Beginners Guide to 21 CFR Part 11 -
Montrium." N.p., n.d. Web. 26 Dec. 2015, http://blog.montrium.com/blog/the-beginners-guide-to-21-cfr-part-11
