Paradiso works with your company to be Part 11 compliant
The Part 11 compliance in Pharmaceutical and food companies talks about the requirements that are necessary to run properly your pharmaceutical or food services with all the regulations that the FDA (Food and Drug Administration) needs. Part 11 compliant standard is the regulation established for e-signatures, auditing, and record keeping. Regulations like the FDA request that your Learning Management System (LMS) is validated for intended use in LMS part 11 compliant.
Title 21 CFR Part 11, commonly known as Part 11 compliant regulation, is the section of the Code of Federal Regulations (CFR) that deals with Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. It defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.
In order to comply with the specified regulations dictated by law, an LMS must count with specific characteristics in its system settings, such as the ability to track the events developed inside the platform. Also, it must have a compliant storage capacity and an e-signature featuring.
What’s the reason to be LMS Part 11 compliant?
This is an increasingly requested requirement from customers and prospects in the Food and drugs sector who are required to adhere to this. A Company using Paradiso LMS can be FDA CFR Part 11 Compliant.
The compliance seeks to regulate the criteria in which electronic records and e-signatures are considered reliable, safe and equivalent to physical records. For this subjects, the FDA has set a list of standards to be followed in order to have Part 11 compliant.
Could a learning platform Solution be LMS Part 11 compliant?
Any solution by itself is compliant. A validation needs to be done across an entire solution, from end-to-end. This includes the data center, the server and related appliances, and the administration of these components. This validation is necessary regardless of whether an organization is using the hardware and software on-premise or if it is hosted via SaaS.
It must be stressed that Part 11 compliance depends on both the technical controls implemented by the LMS and Company controls such as policy and procedure that must be met by the Company itself.
How does Paradiso LMS comply with the Part 11 compliant requirements?
|Requirement||Paradiso LMS features|
|The system shall employ transaction safeguards preventing the unauthorized use of passwords and/or identification codes.||Paradiso LMS includes protection against force password attacks, which will suspend accounts following too many failed login attempts during a specified time period.|
|The system shall detect and report unauthorized use of passwords and/or identification codes to specified units.||Paradiso LMS logs and reports on failed login attempts, sending an email to administrators. Date and time, IP address and username of failed logs are all recorded in the system logs and reported to administrators.|
|The system shall require that passwords be periodically revised.||Paradiso LMS supports setting a password expiry period with an optional notification to the user.|
|The system shall require that each combination of identification code and password is unique, such that no two individuals have the same combination of identification code and password.||Username is unique for every account.|
|The system shall require all attempted uses of an individual’s electronic signature by anyone other than its genuine owner to require the collaboration of two or more individuals.||A user should not share their username and password with other system users. The company should have procedures in place to enforce this.|
|The system shall require the use of all electronic signature components for the signings not executed during a single continuous period of controlled system access.||If the user is not logged in, then their privileges are extremely limited. In order to sign in again, they will need both username and password before they are able to perform any signature action.|
|The system requires the use of all electronic signature components for the first signing during a single continuous period of controlled system access.||In Paradiso LMS, the first signing refers to the user logging into the system. At this stage, the user must enter their username and password to be authenticated as a valid system user. Subsequently, all actions performed are linked with the identity they logged in as.|
|The system shall allow all subsequent signing during the same continuous period of controlled system access to use at least one electronic signature component.||Paradiso LMS give continuous access to the system until the user logs out or their session times out. If a specific action requires the entry of username and password.|
|The system shall ensure users are timed out during periods of specified inactivity.||Paradiso LMS can handle the session timeout. If the user isn't active for that length of time the user is automatically logged off the system. In addition, we provide a log of active sessions.|
|The system shall employ at least two distinct identification components such as an identification code and a password.||Paradiso LMS default authentication method uses 'username' and 'password' for login. Paradiso LMS offers multi-factor authentication functionality if it is needed.|
These are only some of the requirements that Paradiso LMS has taken in the count to make sure that your company becomes Part 11 compliant. It is necessary to clarify that Paradiso LMS is not fully compliant with this regulation. This is because the e-learning industry does not need to be compliant with part 11 by itself. However, Paradiso LMS provides all the options and features necessary for your pharmacy or food company to have a properly structured LMS that complies with the laws dictated by FDA.
Rely on Paradiso Learning Management Software to run all your company’s training processes without having to worry about Part 11 compliance, we will work hand to hand with your company to reach it.
If you would like to get further information about Part 11 compliance and/or try Paradiso LMS, contact our sales team at [email protected]