How Identity and Access Management Supports 21 CFR Part 11

Limiting system access to authorized individuals

Limiting system access to authorized individuals.

In practice: Access to a regulated system is granted by role after a manager's sign-off, removed when someone leaves, and reviewed periodically by the system owner.

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.

In practice: Roles decide who may sign, edit or release a record, separation of duties keeps one person from doing every step, and signing roles go to named people.

Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.

In practice: Every signer has their own identity, shared or recycled signing logins are not allowed, and an old identifier is not handed to a new person.

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.

In practice: A new signer is first confirmed against the HR record in the joiner workflow, and signing credentials are issued only after that confirmation.

(a) Electronic signatures that are not based upon biometrics shall: (1) Employ at least two distinct identification components such as an identification code and password. (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. (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.

In practice: Signers use MFA to sign in, are asked to re-authenticate when they sign, and must enter both components again after a break in the session.

(a) Electronic signatures that are not based upon biometrics shall: [...] (2) Be used only by their genuine owners; and

In practice: Phishing-resistant authenticators, no shared accounts and alerts on sign-in risk events help keep a signature in the hands of its real owner.

(a) Electronic signatures that are not based upon biometrics shall: [...] (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.

In practice: Credential administrators and signers are different people, and any reset or reassignment of a signing credential needs a second person's sign-off in the workflow.

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:

In practice: Password rules, credential lifecycle steps and sign-in monitoring are set up as a set of controls around signing credentials, with each part owned and documented.

Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination of identification code and password.

In practice: Each person has a distinct user ID, and shared credentials are prohibited, so no two people end up with the same ID and password pair.

Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging).

In practice: Credential issuances are checked on a schedule through access reviews, reports that flag dormant accounts, and password aging or compromised-password checks as the organization's policy sets.

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.

In practice: When a token or phone is lost, the help desk revokes it quickly, verifies the person's identity, and enrolls a replacement through a controlled process.

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.

In practice: Lockout rules block repeated guessing, sign-in risk detection spots attempts to misuse credentials, and alerts go straight to the security team.

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:

In practice: The quality or IT team defines overall system controls; identity adds named individual accounts and controlled access so each action on a record traces to one person.

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.

In practice: The system owner configures time-stamped audit trails; identity supplies named accounts and logs so each recorded entry links to an individual.

Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.

In practice: The system team decides when device checks matter; identity can add registered, health-checked devices as a condition for reaching the system.

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.

In practice: Individuals acknowledge a written policy about their e-signatures; identity helps by tying each acknowledgement to a unique account and removing shared logins.

Use of appropriate controls over systems documentation including: (1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance. (2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.

In practice: Documentation owners control who may read or edit system manuals; identity limits those libraries by role and reviews that access from time to time.

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 § 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.

In practice: The quality team governs records exchanged over open networks; identity adds federated sign-in and certificate-based identities to help establish who the sender is.

Signature manifestations

Signed electronic records shall contain information associated with the signing that clearly indicates all of the following: (1) The printed name of the signer; (2) The date and time when the signature was executed; and (3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.

In practice: The records system shows the signer's printed name beside each signature; identity keeps that name accurate by correlating it with the HR record.

Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners.

In practice: The signature system owner handles any biometric signing; identity may enroll device-bound credentials where a fingerprint unlocks a device, without storing templates.

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.

In practice: The security team checks tokens and authenticators on a schedule; identity provides an authenticator inventory, attestation checks at enrollment and a restricted list of accepted authenticator models.

Validation of systems

Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

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.

Protection of records

Protection of records to enable their accurate and ready retrieval throughout the records retention period.

Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.

Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.

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).

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.

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. (1) The certification shall be signed with a traditional handwritten signature and submitted in electronic or paper form. Information on where to submit the certification can be found on FDA's web page on Letters of Non-Repudiation Agreement. (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.