FDA Title 21 CFR Part 11 Checklist

Workflows for Confluence

Confluence

Processes

11.10 (a)

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

Put a validation plan in place. Get expert advice to ensure the scope and the method of validation are most appropriate to how you use the system.

11.10 (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.

Workflows serves an extensive history of pages, including all Approvals that took place (plus e-signature info)

Confluence pages may be exported to PDF and MS-Word. The built-in PDF export may be upgraded with 3rd party apps to provide more comprehensive page metadata in the exported page.

Determine your favored technique for exporting pages from Confluence, and check this information comprises of all the necessary components.

11.10 (c)

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

Put in place a backup policy. Keep backups for the duration required by your records retention policies.

11.10 (d)

Limiting system access to authorized individuals.

Workflows apply all Confluence access restrictions and authorization. It also allows you to specify the permissions for certain actions.

 Confluence allows for the definition of users and groups, and content access control can be based on those groups.

11.10 (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.

Workflows serves an extensive history of pages, including all Approvals that took place (plus e-signature info)

Each modification to a Confluence page becomes a new (unofficial) version. Versions can be compared to show the modifications made.

Confluence needs to be configured and used in a way which supports this requirement:

1. Pages are never deleted but are retired and kept in the system (so that the history is retained).

2. Official versions of pages need to be managed.

11.10 (f)

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

Workflows language provides control mechanisms to support a wide range of business rules.

Configure Workflows to reflect your defined approval process.

11.10 (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.

Workflows verifies the user has the necessary authority to perform key functions, and supports role-based and electronically signed approvals.

see 11.10(d)

see 11.10(d)

11.10 (h)

Compliant Electronic Document Management Systems must use device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.

N/A

N/A

N/A

11.10 (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.

Train your team to use Confluence and Workflows.

Maintain training records.

11.10 (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.

Write company policies to ensure that login information is not shared with others and that signatures are not performed by others.

11.10 (k)(1)

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.

System documentation may be managed within Confluence, using the approval mechanism provided by Workflows.

If system documentation is managed in Confluence, then use Confluence’s “provide access” segregation mechanisms to protect it.

Manage system documentation securely.

If managed in Confluence, this information should also be exported so that it can be used when the system is down (ie, for recovery). This information should be secured to avoid a security breach.

11.50 (a)

Compliant Electronic Document Management Systems ensure that signed electronic documents contain information associated with the signing, clearly indicating all of the following:

1. The printed name of the signer.

2. The date and time when the signature was executed.

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

Workflows provides the 'Approval Information' dialog, for each approval that takes place on a page. This dialog provides the following data for each approval (electronic signature):

1. The full name of the user

2. Date and time of approval

3. The name of approval, which constitutes the meaning of the signature.

11.50 (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).

The Page Info and Dialogs can be printed out to show a clear report of the approvals.

11.70

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.

The linkage between approvals and the Confluence pages is part of the database tables and cannot be falsified through manipulation of the page.

11.100 (a)

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

Workflows uses a 2FA system where users set up their access themselves on their mobile device. This can't be re-used/re-assigned.

11.100 (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.

The 2FA set-up requires users to authenticate themselves using their Confluence email address.

The identity of individuals should be verified before they are granted access.

11.100 (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 requires you to submit to the FDA a document in regards to your use of electronic signatures.

11.200 (a)(1)

Electronic signatures shall employ at least two distinct identification components, such as an identification code and password.

In Workflows, an individual electronically signs an approval by providing their Confluence access credentials: email address and 2FA OTP (One-time password).

These credentials are validated through Workflow's authentication interface.

Define an appropriate workflow, specifying where approvals require electronic signatures.

11.200 (a)(1)(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.

Workflows requires that full credentials are provided for each signature. These are composed of two elements: email address and 2FA OTP (One-time password).

11.200 (a)(1)(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.

Workflows requires that full credentials are provided for each signature. These are composed of two elements: email address and 2FA OTP (One-time password).

11.200 (a)(2)

(Electronic signatures) shall be used only by their genuine owners

 Implement awareness and accountability policies to ensure that login information is not shared with other individuals and that signatures are not performed by another person.

Implement security measures on the infrastructure level to protect and identify breaches.

11.200 (a)(3)

(Electronic signatures) shall 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.

Confluence provides certain protections to password information (i.e. encryption).

More information is provided here.

These protections alone are not sufficient to meet this criteria, but should be seen as part of the solution.

The infrastructure including any user directory and user access mechanisms, need to be setup in a way that protects from the possibility of:

1. re-setting of password information by a single administrator (which will then enable them to posture as another user).

2. theft of password information.

3. breach of access and fraudulent signature.

11.300 (a)

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.

The 2FA OTP that is generated every 30 seconds will be unique to all users.

In Confluence, email is a unique identifier.

Any user sign-on mechanisms should be set in a way that ensures uniqueness across the board.

11.300 (b)

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

Workflows has an Approval Token admin settings, where a list of all Approval Tokens are visible, along with the user, it's expiry date and the ability to revoke the Token at any time.

 Confluence provides the means to make users 'inactive'. That way users may be blocked from accessing the system without losing their historical data.

Put policies in place to ensure that your user list and access rights are current. For example:

1. off-boarding of staff needs to include discontinuity of their respective user accounts.

2. access rights are periodically reviewed.

11.300 (c)

Following loss management procedures to electronically de-authorize 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.

Workflows has an Approval Token admin settings, where a list of all Approval Tokens are visible, along with the user, it's expiry date and the ability to revoke the Token at any time.

If you are using tokens or other devices to help gain system access, take measures to manage theft, loss etc of those devices.

11.300 (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.

If a user, attempts to use his Approval Token more than 10 times incorrectly then their token is revoked and they have to sign up a new Approval Token.

Implement security monitoring and protection.

11.300 (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.

Relates to a scenario in which you are using tokens or other devices to help gain system access.