Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, room 1061, Rockville, MD 20852. All comments should be identified with the docket number 00D-1543.

2. Scope *

3. Definitions *

4. References *

  Purpose

1. Scope

This draft guidance is one of a series of guidances about part 11. We intend to provide information with respect to FDA's current thinking on acceptable ways of meeting part 11 requirements to ensure that electronic records and electronic signatures are trustworthy, reliable, and compatible with FDA's public health responsibilities.

In this draft guidance we define terms that will be used throughout other guidances in this series.

 

1. Applicability

This draft guidance applies to electronic records and electronic signatures that persons create, modify, maintain, archive, retrieve, or transmit under any records or signature requirement set forth in the Federal Food, Drug, and Cosmetic Act (the Act), the Public Health Service Act (PHS Act), or any FDA regulation. Any requirements set forth in the Act, the PHS Act, or any FDA regulation, with the exception of part 11, are referred to in this document as predicate rules. Most predicate rules are contained in Title 21 of the Code of Federal Regulations. In general, predicate rules address the research, production, and control of FDA regulated articles, and fall into several broad categories. Examples of such categories include, but are not limited to: manufacturing practices, laboratory practices, clinical and pre-clinical research, adverse event reporting, product tracking, and pre and post marketing submissions and reports.

 

2. Audience

1. Definitions

Definitions drawn from particular references are followed by a bracketed number to identify the reference. A listing of references appears in section 4.

Term	Definition
Biometrics	A method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable actions where those features and/or actions are both unique to that individual and measurable.[1]
Closed System	An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.[1]
Computer Systems Validation	Confirmation by examination and provision of objective evidence that computer system specifications conform to user needs and intended uses, and that all requirements can be consistently fulfilled.
Digital Signature	An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.[1]
Electronic Record	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.[1]
Electronic Signature	A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.[1]
Handwritten Signature	The scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.[1]
Off-the-Shelf Software (OTS software)	A generally available software component for which the user can not claim complete software life cycle control.[3]
Open System	An environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.[1]
Person	Includes an individual, partnership, corporation, and association. [4]
Predicate Rule	Requirements set forth in the Act, the PHS Act, or any FDA regulation, with the exception of part 11.
Regression Analysis And Testing	A software verification and validation task to determine the extent of verification and validation analysis and testing that must be repeated when changes are made to any previously examined software products.[5]
Regression Testing	Rerunning test cases which a program has previously executed correctly in order to detect errors spawned by changes or corrections made during software development and maintenance.[5]
Reliability	The ability of a system or component to perform its required functions under stated conditions for a specified period of time.[2]

 

 

2. References