BACK
Sample Pages RCGLOBAL
Sample pages of
Evidence Product Checklist
for the FDA Document
“FDA 21 CFR Part 11 - Electronic Records; Electronic Signatures; Final Rule”
Introduction
The process of defining what is necessary for compliance with a document such as “FDA 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. This checklist was produced to aid in determining what is actually “required” by the document in the way of physical evidence of compliance. The checklist is constructed around a classification scheme of physical evidence comprised of policies, procedures, plans, records, documents, audits, and reviews. Based upon this classification scheme, this FDA document was carefully reviewed and required physical evidence required was defined. A second review of the complete list was conducted 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 “FDA 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. These individual items have been called out 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 “FDA 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.
 

FDA 21 CFR Part 11 
Electronic Records and Electronic Signatures; Final Rule
POLICIES and PROCEDURES
PLANS
RECORDS
DOCUMENTS
AUDITS and REVIEWS
11.0 General Provisions  . . . . .
11.1 Scope . . . . .
11.2 Implementation . . . . .
11.3 Definitions . . . . .
11.10 Controls for Closed Systems
  • Creation, Maintenance and Deletion of Electronic Records in a Closed System Procedure
  • Electronic Record Keeping and Electronic Signatures Policy 
  • Electronic Record Keeping and Electronic Signatures System Change Control Procedure
  • Electronic Record Keeping and Electronic Signatures System Document Procedure
  • Electronic Record Keeping and Electronic Signatures System Documentation Change Control Procedure
  • Electronic Record Keeping and Electronic Signatures Training Procedure
  • Electronic Records System Equipment Checking and Operations Procedure
  • Electronic Records System Revision and Change Control Procedure
  • Electronic Records System Security Procedure*
  • Records (Human Readable and Electronic) Copying and Archive Procedure
  • Electronic Record Keeping and Electronic Signatures Training Plan 
  • Electronic Records and Signatures Validation and Test Plan 
  • Security Plan*
  • Audit Trail Records
  • Electronic Record Keeping and Electronic Signatures Training Records
  • Electronic Records
  • System Validation and Test Records
  • Electronic Record Keeping and Electronic Signatures System Document
  • Creation, Maintenance and Deletion of Electronic Records in a Closed System Procedure Review*
  • Electronic Record Keeping and Electronic Signatures Policy Review* 
  • Electronic Record Keeping and Electronic Signatures System Audit*
  • Electronic Record Keeping and Electronic Signatures System Change Control Procedure Review*
  • Electronic Record Keeping and Electronic Signatures System Document Procedure Review*
  • Electronic Record Keeping and Electronic Signatures System Document Review*
  • Electronic Record Keeping and Electronic Signatures System Documentation Audit*
  • Electronic Record Keeping and Electronic Signatures System Documentation Change Control Procedure Review*
  • Electronic Record Keeping and Electronic Signatures Training Plan Review*
  • Electronic Record Keeping and Electronic Signatures Training Procedure Review*
  • Electronic Records and Signatures Validation and Test Plan Review*
  • Electronic Records System Equipment Checking and Operations Procedure Review*
  • Electronic Records System Revision and Change Control Procedure Review*
  • Electronic Records System Security Procedure Review*
  • Records (Human Readable and Electronic) Copying and Archive Procedure Review*
  • Security Plan Review*

 
FDA 21 CFR Part 11 
Electronic Records and Electronic Signatures; Final Rule
RECORDS AVAILABILITY NOT REQUIRED RATIONALE COMMENTS
11.10 Controls for Closed Systems
  • Audit Trail Records
  • Electronic Record Keeping and Electronic Signatures Training Records
  • Electronic Records
  • System Validation and Test Records
. . .
11.50 Signature Manifestations
  • Signature Manifestation Records
  • Valid Electronic Signature Records 
. . .
11.70 Signature/Record Linking
  • Signature/ Record Linking Records
. . .
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