This document provides point-to-point comments for the 21 CFR Part 11 regulation. The comments provided are applicable to version 2000 or higher of STABILITY SYSTEM.
In our own assessment, STABILITY SYSTEM version 2000 or higher is fully Part 11 compliant.
Note: The FDA issued a new guideline for Part 11 in September 2003.
Those provisions in the Part 11 regulation that FDA specifies to intend to enforce are highlighted in red and bold below.
Those provisions that FDA specifies to intend to exercise enforcement discretion are highlighted in blue below.
| 21 CFR Part 11 Text | Comments by ScienTek Software |
|---|---|
| Sec. 11.1 Scope | |
| (a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. | STABILITY SYSTEM manages electronic records and uses electronic signatures via a login name and a password.
STABILITY SYSTEM does not use an electronic manifestation of the handwritten signature. |
| (b) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means. | With this definition, STABILITY SYSTEM falls into the jurisdiction of Part 11 regulation. |
| c) Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic signatures to be equivalent to full handwritten signatures, initials, and other general signings as required by agency regulations, unless specifically excepted by regulation(s) effective on or after August 20, 1997. | See comments for Sec. 11.1 (b) |
| (d) Electronic records that meet the requirements of this part may be used in lieu of paper records, in accordance with Sec. 11.2, unless paper records are specifically required. | See comments for Sec. 11.1 (b) |
| (e) Computer systems (including hardware and software), controls, and attendant documentation maintained under this part shall be readily available for, and subject to, FDA inspection. | See comments for Sec. 11.1 (b) |
| Sec. 11.2 Implementation | |
| (a) For records required to be maintained but not submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that the requirements of this part are met. | See comments for Sec. 11.1 (b) |
| (b) For records submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that:
(1) The requirements of this part are met; and (2) The document or parts of a document to be submitted have been identified in public docket No. 92S-0251 as being the type of submission the agency accepts in electronic form. This docket will identify specifically what types of documents or parts of documents are acceptable for submission in electronic form without paper records and the agency receiving unit(s) (e.g., specific center, office, division, branch) to which such submissions may be made. Documents to agency receiving unit(s) not specified in the public docket will not be considered as official if they are submitted in electronic form; paper forms of such documents will be considered as official and must accompany any electronic records. Persons are expected to consult with the intended agency receiving unit for details on how (e.g., method of transmission, media, file formats, and technical protocols) and whether to proceed with the electronic submission. |
See comments for Sec. 11.1 (b)
User determines the information from STABILITY SYSTEM to be submitted to the FDA in the electronic forms. |
| Sec. 11.3 Definitions | |
| (a) The definitions and interpretations of terms contained in section 201 of the act apply to those terms when used in this part. | No comment is necessary. |
| (b) The following definitions of terms also apply to this part: | No comment is necessary. |
| (1) Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-903 (21 U.S.C. 321-393)). | No comment is necessary. |
| (2) Agency means the Food and Drug Administration. | No comment is necessary. |
| (3) Biometrics means a method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable. | STABILITY SYSTEM does not use biometric signatures.
See also comments for Sec. 11.1 (a) |
| (4) Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. | STABILITY SYSTEM is a closed system. |
| (5) Digital signature means 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. | STABILITY SYSTEM uses electronic signatures via a login name and a password.
STABILITY SYSTEM does not use an electronic manifestation of the handwritten signature. |
| (6) Electronic record 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. | STABILITY SYSTEM deals all types of electronic records mentioned except for the audio information. |
| (7) Electronic signature means 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 | STABILITY SYSTEM uses electronic signatures via a login name and a password.
STABILITY SYSTEM does not use an electronic manifestation of the handwritten signature. |
| (8) Handwritten signature means 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. | STABILITY SYSTEM does not use an electronic manifestation of the handwritten signature. |
| (9) Open system means 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. | STABILITY SYSTEM is NOT an open system. |
| Sec. 11.10 Controls for closed systems | |
| Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following: | No comment is necessary. |
| (a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. | STABILITY SYSTEM has a mandatory audit trail facility to keep track of the editing activities. |
| (b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records. | STABILITY SYSTEM can generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. |
| (c) Protection of records to enable their accurate and ready retrieval throughout the records retention period. | STABILITY SYSTEM protects records to enable their accurate and ready retrieval throughout the records retention period.
STABILITY SYSTEM protects your stability information by encrypting the information. |
| (d) Limiting system access to authorized individuals. | The use of STABILITY SYSTEM is controlled by a login procedure which requires a login name (up to eight alphanumeric characters and is not case sensitive) and a password (up to twelve alphanumeric characters and is case sensitive). Each user account is associated with a security level which controls the extent that each user can use STABILITY SYSTEM options. For example, some users can edit records; some users can only read information and cannot edit.
Each installation can designate users who will be notified for all failed login activities via the internal email system. The administrator can specify the minimum number of characters for the password. |
| (e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying. | STABILITY SYSTEM has a mandatory audit trail facility to keep track of the editing activities.
The audit trail keeps track of the following information:
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| (f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate. | STABILITY SYSTEM is designed in such a way to ensure that the user is limited to one function at a time. This enforces permitted sequencing of steps and events, as appropriate. |
| (g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand. | See comments for Sec. 11.10 (d) |
| (h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction. | The stability information is typed. This requirement is not applicable to STABILITY SYSTEM. |
| (i) Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks. | This is a user's responsibility. |
| (j) The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification. | This is a user's responsibility. Needs to develop in-house SOP. |
| (k) Use of appropriate controls over systems documentation including: | No comment is necessary. |
| (1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance. | This is a user's responsibility. Needs to develop in-house SOP. |
| (2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation. | STABILITY SYSTEM provides the audit trail.
Otherwise, this is a user’s responsibility. Needs to develop in-house SOP. |
| Sec. 11.30 Controls for open systems | |
| Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt. Such procedures and controls shall include those identified in Sec. 11.10, as appropriate, and additional measures such as document encryption and use of appropriate digital signature standards to ensure, as necessary under the circumstances, record authenticity, integrity, and confidentiality. | STABILITY SYSTEM is NOT an open system. This section is NOT applicable to STABILITY SYSTEM. |
| Sec. 11.50 Signature manifestations | |
| (a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the following: | No comment is necessary. |
| (1) The printed name of the signer; | Yes, see comments for Sec. 11.10 (e) |
| (2) The date and time when the signature was executed; and | Yes, see comments for Sec. 11.10 (e) |
| (3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature. | Yes, see comments for Sec. 11.10 (e) |
| (b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout). | Yes. The audit trail file is protected by encryption. It can be displayed on the screen or printed as hardcopy by certain authorized users of STABILITY SYSTEM. |
| Sec. 11.70 Signature/record linking | |
| Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means. | Yes, see comments for Sec. 11.10 (e) |
| Subpart C--Electronic Signatures | |
| Sec. 11.100 General requirements | |
| (a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else. | Within STABILITY SYSTEM, each user assigns his or her password. Therefore, it is impossible to reassign an electronic signature to anyone else.
Once used, the login name and the password (even for a deleted user account) cannot be reused by anyone. |
| (b) Before an organization establishes, assigns, certifies, or otherwise sanctions an individual's electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual. | This is a user's responsibility. Needs to develop in-house SOP. |
| (c) Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures. | This is a user's responsibility. |
| (1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857. | This is a user's responsibility. |
| (2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer's handwritten signature. | This is a user's responsibility. |
| Sec. 11.200 Electronic signature components and controls | |
| (a) Electronic signatures that are not based upon biometrics shall: | No comment is necessary. |
| (1) Employ at least two distinct identification components such as an identification code and password. | STABILITY SYSTEM identifies each user by three pieces of information: login name, password and printed name. |
| (i) When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual. | Within STABILITY SYSTEM, each audit trail record is ALWAYS identified by two pieces of information regarding the user: login name and printed name. |
| (ii) When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signing shall be executed using all of the electronic signature components. | Within STABILITY SYSTEM, each audit trail record is ALWAYS identified by two pieces of information regarding the user: login name and printed name. |
| (2) Be used only by their genuine owners; and | Yes, see comments for Sec. 11.100 (a) |
| (3) Be administered and executed to ensure that attempted use of an individual's electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals. | Yes, see comments for Sec. 11.100 (a) |
| (b) Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners. | STABILITY SYSTEM does not use an electronic manifestation of the handwritten signature. |
| Sec. 11.300 Controls for identification codes/passwords | |
| Persons who use electronic signatures based upon use of identification codes in combination with passwords shall employ controls to ensure their security and integrity. Such controls shall include: | No comment is necessary. |
| (a) Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination of identification code and password. | Yes, see comments for Sec. 11.100 (a) |
| (b) Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging). | Yes. STABILITY SYSTEM utilizes a user-specified time threshold (from 30 to 360 days) to force each user to change the password. In addition, each user can change the password at any time. Once used, the password cannot be reused. |
| (c) Following loss management procedures to electronically deauthorize lost, stolen, missing, or otherwise potentially compromised tokens, cards, and other devices that bear or generate identification code or password information, and to issue temporary or permanent replacements using suitable, rigorous controls. | Within STABILITY SYSTEM, a user who forgets his/her password must be deleted from the user ID table and a new user account must be issued again. The user then assigns a new password to the new user account.
The login name and password of a deleted user account cannot be reused. |
| (d) Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and report in an immediate and urgent manner any attempts at their unauthorized use to the system security unit, and, as appropriate, to organizational management. | STABILITY SYSTEM tracks the login and logout activities in the audit trail. The system administrator can query the audit trail for such activities.
Each installation can designate users who will be notified for all failed login activities via the internal email system. |
| (e) Initial and periodic testing of devices, such as tokens or cards, that bear or generate identification code or password information to ensure that they function properly and have not been altered in an unauthorized manner. | This is a user’s responsibility. Needs to develop in-house SOP. |