Introduction
The process of defining what is necessary for compliance with a document
such as " 21 CFR Part 11 Electronic Records; Electronic Signatures;
Final Rule" is sometimes confusing and laborious because the directions
contained in the document may be unclear or ambiguous. To aid in determining
what is actually “required ” by the document in the way of physical evidence
of compliance, the experts at SEPT have produced this checklist. This checklist
is constructed around a classification scheme of physical evidence comprised
of policies, procedures, plans, records, documents, audits, and reviews.
SEPT has carefully reviewed this FDA document and defined the physical
evidence required based upon this classification scheme. SEPT has conducted
a second review of the complete list to ensure that the document’s producers
did not leave out a physical piece of evidence that a “reasonable person”
would expect to find. It could certainly be argued that if the document
did not call it out then it is not required; however if this document were
used by an enterprise to improve its software process, then it would make
sense to recognize missing documents. Therefore, there are documents specified
in this checklist, though not specifically called out, which are implied
by “21 CFR Part 11 Electronic Records; Electronic Signatures; Final
Rule”. These implied documents are designated by an asterisk (*) throughout
this checklist. If a document is called out more than one time, only the
first reference is stipulated.
There are occasional situations in which a procedure or document is
not necessarily separate and could be contained within another document.
For example, the Software Detail Specification Document could be a subset
of Software Design Specification. SEPT has called out these individual
items separately to ensure that the organization does not overlook any
facet of physical evidence. If the organization does not require a separate
document, and an item can be a subset of another document or record, then
this fact should be denoted in the detail section of the checklist for
that item. This should be done in the form of a statement reflecting that
the information for this document may be found in section XX of Document
XYZ. If the organizational requirements do not call for this physical evidence
for a particular project, this should also be denoted with a statement
reflecting that this physical evidence is not required and why. The reasons
for the evidence not being required should be clearly presented in this
statement. Further details on this step are provided in the in the Detail
Steps section of the introduction. The size of these documents could vary
from paragraphs to volumes depending upon the size and complexity of the
software project or business requirements.
This checklist is focused solely on “21 CFR Part 11 Electronic Records;
Electronic Signatures; Final Rule”. It does not cover the requirements
for any other standard unless so stated.
FDA Document Checklist for Electronic Records and Electronic Signatures
This checklist was prepared by analyzing each clause of this document
for the key words that signify a:
-
Policy
-
Procedure
-
Plan
-
Records
-
Document
-
Audit
-
Review
This checklist specifies evidence that is unique to the process necessary
for electronic records and electronic signatures. After reviewing the completed
document, the second review was conducted from a common sense “reasonable
man” approach. If a document or other piece of evidence appeared to be
required, but was not called out in the document, then it is added with
an asterisk (*) after its notation in the checklist. The information was
transferred into checklist tables, based on the type of product or evidence.
Using the Checklist
When a company is planning to use this document to ensure their compliance
to FDA 21 CFR Part 11, the company should review this evidence checklist.
If the company’s present process does not address an evidence product delineated
in this document, then this question should be asked: “Is the evidence
product required for the type of product or services the business is producing?”
If in the view of the company the evidence is not required, the rationale
should be documented and inserted in the appropriate organizational records.
This rationale should pass “the reasonable person rule.” If the
evidence is required, plans should be prepared to address the missing items.
Detail Steps
An enterprise should compare the proposed output of their project or
organization against the checklist. In doing this, they will find one of
five conditions that exist for each item listed in the checklist. The following
five conditions and the actions required by these conditions are listed
in the table below.
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