Electronic signatures

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

FactoryTalk Optix Studio allows creation or integration of unique login profiles for each user, either through local FactoryTalk Optix users or Active Directory users.

If managing local FactoryTalk Optix users, during both the design time and runtime, the

User editor

widget allows to create and manage any newly created users, as well as the enablement of their login credentials.

Procedures should be implemented to ensure that user IDs do not get deleted or reassigned. It is recommended to disable user IDs rather than deleting them as a best practice.

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 FactoryTalk Optix Studio, once a user is sanctioned and a unique account has been created, the user is required to enter their login credentials and password to access the application. Furthermore, each user can be set so as to be prompted to change their password after their first login, either through Doman policy or through custom NetLogic script. This process validates the user identity.

Customer is responsible for informing the FDA about their willingness to use the electronic signature as a legally binding equivalent of traditional handwritten signatures.

Once a user has been sanctioned and a unique account with a password has been created in FactoryTalk Optix Studio, the user is required to enter their login and password to access FactoryTalk Optix Studio. This process validates the identity of the user to FactoryTalk Optix Studio.

Persons using electronic signatures shall, before 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.

Customer is responsible for informing the FDA about their willingness to use the electronic signature as a legally binding equivalent of traditional handwritten signatures.

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.

Customer is responsible for informing the FDA about their willingness to use the electronic signature as alegally binding equivalent of traditional handwritten signatures.

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.

If required, customer is responsible for providing any proof of the use of electronic signature as a legally binding equivalent of traditional handwritten signatures.

In FactoryTalk Optix Studio it is possible to set up the

File sign and verify

NetLogic to electronically sign files and verify the signed files integrity.

Electronic signatures that are not based on biometrics shall:

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

FactoryTalk Optix Studio requires two components for user identification: a user name and a password.

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.

FactoryTalk Optix Studio requires the user identification through a unique login ID and a password that need to be entered into the initial login section of the application. The user shall re-enter their login ID and password after every logout. This can be implemented by use of login forms.

The FactoryTalk Optix Studio electronic signature process requires the logged in operator to provide their password. The operator cannot execute any electronic signature unless they have previously logged in to the application. When an electronic signature is configured in such a way to require an approver’s signature, the approver shall enter their unique login ID and password for each electronic signature executed.

When an individual executes one or more signings not performed during one continuous period of controlled system access, each signing shall be executed using all electronic signature components.

Customer shall implement logout procedures to enforce the user log off at the end of any period of controlled system access, and the user login when the next access period starts. An auto-logout feature can be set to ensure that a workstation is not left unattended. This is done by creating an inactivity timer set to trigger specific actions (such as a logout) after a given time.

In the FactoryTalk Optix Studio signing workflow, it is possible to configure single objects or operations.

The FactoryTalk Optix Studio electronic signature process requires the logged in operator to provide their password. The operator cannot execute any electronic signature unless they have previously logged in to the application by providing their unique login ID and password. When an electronic signature is configured to require an approver’s signature, the approver must enter their unique login ID and password for each electronic signature executed.

To be used only by their genuine owners.

The customer is responsible for ensuring that the genuine owner is signing the electronic signature and that the password is not being disclosed to others. In FactoryTalk Optix Studio it is possible to set a genuine owner, such as a user or group, or a user and a group, or a user only, for individual signing workflows.

To be administered and executed to provide confidence that attempted use of an individual’s electronic signature by anyone other than its genuine owner requires the collaboration between two or more individuals.

The customer should implement appropriate procedures to handle situations that require an electronic signature by anyone other than its genuine owner. It is possible to set multiple genuine owners in the signing workflow.

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

FactoryTalk Optix Studio supports biometric devices connected to panels and allows to manage authorizations for accessing biometrics data.The implementation of any measures aimed at meeting this requirement lies with the customer.

Persons who use electronic signatures based on the use of identification codes in combination with passwords shall employ controls to provide confidence that their security and integrity. Such controls shall include:

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

FactoryTalk Optix Studio allows to configure individual domain security settings. A user account can be disabled or inactivated without deleting the user’s login ID.

FactoryTalk Optix Studio keeps all login IDs to help prevent reuse or reassignment of previously created login IDs.

Confirming that identification code and password issuances are periodically checked, recalled, or revised (for example, to cover such events as password aging).

FactoryTalk Optix Studio enables you to integrate domain security settings for account management. Alternatively, FactoryTalk Optix Studio enables you to configure these security settings for local Factorytalk Optix accounts: password expiration, password aging, password complexity requirements, account expiration, disabling of accounts, lockout after several invalid login attempts, and forcing a password change at the first login.

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.

The customer is responsible for implementing loss management procedures.

Use of transaction safeguards to help 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.

All the users activities are logged in databases and it is possible to generate reports.

FactoryTalk Optix enables you to integrate domain security settings for account management. Alternatively, security mechanisms for local FactoryTalk Optix accounts are provided to detect any unauthorized use if rules for authorized use are maintained. For example, a rule might stipulate that an account gets locked after three incorrect login attempts.

Login attempts, whether successful or not, are logged by the system.

Initial and periodic testing of devices, such as tokens or cards, that bear or generate identification code or password information to help verify that they function properly and have not been altered in an unauthorized manner.

Customer's management procedures shall include periodic test and validation of any devices that may risk the integrity of a user’s identification.

An administrator user can check any activities in the activities logger and deploy deploy partial permission or remove the access for a particular user at runtime.