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.