Antrix, Inc ANTRIX, Inc
Regulatory Affairs & Quality Assurance Consulting Services for
Medical Device and Medicinal Drugs
O 408 733 1199
F 408 730 5959

Title 21 CFR Part 11 Assessment and Compliance

1.Service Description

We provide complete Title 21 CFR Part 11 Assessment and Compliance service for any of your products having electronic records and signatures. The purpose of Part 11 Regulation Issued by FDA is to establish criteria for electronic recordkeeping while maintaining FDA’s ability to protect and promote public health. FDA’s two major areas of concern are Data Falsification and Data Security.

There will be productivity increase and cost savings of more than 60% using our service. Your company will save money from several thousand to millions of dollars adding to your bottom line profit.

Title 21 CFR Part 11 Applicability

Figure 1 - Title 21 CFR Part 11 Applicability

2. Cost Savings - Return on Investments (ROI)

Amount of money saved by your company on using our service based on the company size is provided in the Table 1.0.

Projected savings is based on

  1. Process efficiency gains (people)
  2. Less personnel requirements (people)
  3. Infrastructure efficiency gains (systems)
  4. Infrastructure validation and maintenance (systems)
  5. Delivering quality products
  6. Avoid regulatory noncompliance cost
  7. Avoid regulatory fines cost

Compared to cost associated with company's inefficient internal manual methods, , systems, tools, software’s, and personnel etc. Detailed Return on Investment (ROI) information is available on request.

Company Size Small Medium Large
$Savings > 20 % > 40 % > 60 %
Annual Sales < $100 million $100 million < Sales < $500 million > $500 million
Number of Submissions <= 2 per year 2 < Sub <= 4 per year > 4 per year

Table 1.0 - Amount of money saved by your company on using our service. Company size is based on annual sales as per FDA classification.

3. Solution Approach

Our Title 21 CFR Part 11 assessment approach is as follows

  1. Perform gap analysis between your product and Title 21 CFR Part 11 requirements
  2. Implement missing Title 21 CFR Part 11 functionality in the product
  3. Implement Standard Operating Procedures as required

We define the technical and procedural controls that companies must apply when records required by FDA regulation are maintained in an electronic format.

  1. Technical controls - implemented within the system require validation
  2. Procedural controls - implemented via SOP require verification

In some situations, both types of controls may be required.

What is Title 21 CFR Part 11?

Title 21 CFR Part 11 final rule provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. These regulations, which apply to all FDA program areas, are intended to permit the widest possible use of electronic technology.

The complete copy of the Title 21 CFR Part 11 requirements document can be found at FDA web site

Who is affected by Part 11?

  1. Applies to all records required by FDA regulations, the FD&C Act, or the PHS Act. (referred to as the Predicate Rules)
  2. Applies to all signatures required on these records or those signatures that are not required but appear in the records.
  3. Applies to all FDA program areas

What are Predicate Rules?

It is very important to understand that 21 CFR part 11 sits on top of other regulations like:

  1. GMP – Title 21 CFR Part 211
  2. GLP – Title 21 CFR Part 58
  3. GCP - ICH E6
  4. QSR - Title 21 CFR Part 820

You need to go to the other regulations to determine if you need to have a specific record.  If you do, and you want to maintain that record electronically rather than on paper - part 11 tells you what you must do for that record to be accepted by FDA. Same is true for signatures.

Title 21 CFR Part 11 Compliance Scope

This section is intended to provide guidance on the use of the any product in relative to compliance with the Electronic Records / Electronic Signature rule (Title 21 CFR Part 11). To fully meet the intent of the rule, both the product design and the operational practices of the FDA-regulated firm must be properly addressed. This guidance describes the elements of the product’s design that promote compliance, as well as outlines the recommended practices to be incorporated within standard operating procedures by the firm. The main intent of this version of the section is to define the basic statement of work required to fully comply with the rule without imposing undue manual procedures on the regulated customer.

This guidance section provides useful information to:

  • Persons subject to Part 11
  • Persons responsible for creating, modifying, maintaining, archiving, retrieving, or transmitting  electronic records or electronic signatures
  • Persons who develop products or services to enable implementation of Part 11 requirements

4. Definitions

Electronic Records: means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system,

Electronic Signature: means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be legally binding equivalent of the individual's signature.

5. Applicable Laws, Regulations and Standards

  1. Food and Drug Administration, CDRH. (1997). Title 21 CFR Part 11 Electronic Records; Electronic Signatures;
  2. Off-The-Shelf Software Use in Medical Devices
  3. General Principles of Software Validation; Final Guidance for Industry and FDA Staff –