21CFR Part 11 - Electronic Event Records and Electronic Signatures

Telemetry2U Compliance

Telemetry2U’s IoT Platform ( https://telemetry2u.com) is 21CFR compliant in regard to electronic event records and electronic signatures (eSignatures) as described in Part 11 (Subparts A,B, and C).

21CFR is an optional feature enabled on a per-client basis, contact sales for more information or to have it activated.

Once 21CFR is activated on a company account, all relevant events or tasks will require approval by an authorised user before any changes can be saved. Approval is given when the authorised user enters their Username and Password in a section called 21CFR confirmation required found at the bottom of every relevant page. In order to approve any 21CFR tasks, the 'approver/authorised user' must have the Confirm CFR21 Action role assigned under User Access Controls. Read more about how to do this in Section 6.2.3 - User Access Controls.

With 21CFR activated, all relevant events/tasks are electronically recorded and made available for download in the from of an Audit Report by checking the Audit events checkbox. Read more about how this can be done in Section 5.1- Creating and Editing Audit Reports).

The section below provides details on the FDA's 21CFR Part 11 along with some notes on how Telemetry2U complies with each section.

Green Tick

= Fully Compatible with 21CFR.

Warning

= Compliant with user control via SOPs (Standard Operating Procedures).

Any notes relevant to Telemetry2U's compliance are on grey backgrounds below each point.

Section 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:

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

Telemetry2u.com provides both Device and System Audit trails detailing user activities.

Green Tick

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.

Telemetry2u.com can be used to generate complete copies of all records in both human readable and electronic form - which can be used for inspection, review and copying by the agency.

Green Tick

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

Green Tick

d) Limiting system access to authorized individuals.

Green Tick

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.

Green Tick

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

Green Tick

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.

Yes - please see Sec. 11.10 d).

Green Tick

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

N/A

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.

Green Tick Warning

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.

Green Tick Warning

k) 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.

Green Tick Warning

2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.

Green Tick Warning

Section 11.50 - Signature Manifestations

a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:

1) The printed name of the signer;

Yes - please see Sec. 11.10 e).

Green Tick

2) The date and time when the signature was executed; and

Yes - please see Sec. 11.10 e).

Green Tick

2) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.

Yes - please see Sec. 11.10 e).

Green Tick

a) The items identified in paragraphs a1), a2), and a3) 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 - please see Sec. 11.10 e).

Green Tick

Section 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 - please see Sec. 11.10 e).

Green Tick

Subpart C - Section 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.

Green Tick

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 the responsibility of the end user. The end user requires thier own SOP's

Green Tick Warning

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 the responsibility of the end user. The end user requires thier own SOP's

Green Tick Warning

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 the responsibility of the end user. The end user requires thier own SOP's

Green Tick Warning

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 the responsibility of the end user. The end user requires thier own SOP's

Green Tick Warning

Section 11.200 - Electronic Signature Components and Controls

a) Electronic signatures that are not based upon biometrics shall:

Green Tick

1) Employ at least two distinct identification components such as an identification code and password.

Green Tick

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.

Green Tick

ii) 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.

Green Tick

2) Be used only by their genuine owners; and

Please see Sec. 11.100 a).

Green Tick

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.

Please see Sec. 11.100 a).

Green Tick

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

N/A

Section 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:

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.

Please see Sec. 11.100 a).

Green Tick

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

Green Tick

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.

Green Tick Warning

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.

Green Tick

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 the responsibility of the end user. The end user requires thier own SOP's

Green Tick Warning

Recorded Events

Below is a list of all audited events that are recorded by Telemetry2U users who have 21CFR enabled on their company account. All events are recorded with a Time stamp, the User who initiated the event, the Event Type, and the Entity Involved.

  • Action added
  • Action deleted
  • Action modified
  • Action step added
  • Action step deleted
  • Action step modified
  • Alert added
  • Alert condition added
  • Alert condition deleted
  • Alert condition modified
  • Alert deleted
  • Alert modified
  • Alert notification group added
  • Alert notification group removed
  • Certificate added
  • Certificate deleted
  • Confirm action failed - invalid e-mail or password
  • Confirm action failed - not authorised
  • Document electronically signed
  • Login failure - account locked out
  • Login failure - incorrect password
  • New user account created
  • Node access granted to user
  • Node access revoked from user
  • Node added
  • Node calibration performed
  • Node command sent
  • Node deleted
  • Node input label added
  • Node input label deleted
  • Node input label modified
  • Node modified
  • Notification group added
  • Notification group deleted
  • Notification group member added
  • Notification group member changed
  • Notification group member removed
  • Notification group modified
  • Roles granted to user
  • Roles revoked from user
  • Scheduled job added
  • Scheduled job deleted
  • Scheduled job modified
  • User confirmed action with password
  • User details added
  • User details deleted
  • User details modified
  • User has asked for resend of e-mail confirmation
  • User has changed password
  • User has confirmed e-mail
  • User has confirmed e-mail change
  • User has initiated forgotten password request
  • User has logged in
  • User has logged out