FDA 21 CFR PART 11

zenon consistently meets FDA 21 CFR Part 11 criteria across all of its modules. The zenon principle of setting parameters rather than programming, the high level of object orientation and managing multiple projects saves up to 90% of validation costs for new projects. FDA 21 CFR 11 stipulates that all electronic data must meet certain requirements to ensure comprehensive documentation of all processes that is safe from manipulation. Thus, a significant element in FDA 21 CFR Part 11 compliant projects is the audit trail.

Audit Trail in Editor

zenon records all project changes in the Editor, without exception (new creation, changes, deletions, copy and import of XML import). Changed object, change type, timestamp, user, workplace, old value, new value and a field for free comments are recorded. Data is saved in the project database. Data can be viewed in a clear list, filtered or exported in CSV format. This enables full traceability at the Publisher. Additionally, zenon's version management ensures the possibility to create project restore points at any time.

 

Fast Facts

Full compliance with FDA 21 CFR Part 11

Compliance with FDA 21 CFR Part 11 with just a mouse click

Consistent environment for HMI, SCADA and MES applications

Solution integrated in all modules

Independent of version

Audit trail at runtime

The Chronological Event List (CEL)serves as an FDA-compliant audit trail. All relevant changes are recorded here permanently and in a way that prevents manipulation. This covers target value requirements as well as revenue and changes to archive entries. The following information is recorded in the protocol: The CEL log documents that were changed, the new and old values, the date and time of the change, the user, the computer on which the change was made and the signature in the case of actions signed. In addition, a comment can be saved for each entry. Alarm management serves as an audit trail for alarms. Also here, all information regarding alarm confirmation is recorded in compliance with FDA. This ensures full traceability at zenon runtime.

 

Administration of users and subscriptions

According to FDA 21 CFR Part 11 , unauthorized access is not permissible, not even when systems protected by a username and password have a user logged in and the user leaves the workplace for a short period of time. zenon guarantees this with its signature concept: each user must perform their own verification before using the system, even if they are already logged into the system. This subscription process is saved in CEL. An editable signature text is also registered to allow the action taken to be recorded accurately.

21 CFR Part 11: FDA and the importance of system validation

 

For companies operating in the healthcare area and wishing to export their products to the United States, adopting 21 CFR Part 11 is of fundamental importance. This standard was created by the FDA and aims to regulate the computerized automation systems of p

harmaceutical industries.

 

Adapting to 21 CFR Part 11 can be interesting for many industries, since Anvisa (National Health Surveillance Agency) also has an equivalent standard, RDC 301/2019. It is worth remembering that the quality and safety of the production of companies linked to the health area must be constantly ensured, thus guaranteeing the minimum risk to patients.

 

For such control, it is necessary that the processes meet specific standards of the control bodies throughout the production chain, avoiding any error or violation. Thus, the two fundamental points of the 21 CFR Part 11 standard refer to the standards required for data storage and electronic signatures and for the entire life cycle of medicines, from development to distribution and sale.

 

What is system validation?

System validation is a step performed with the company that hires or purchases a system. It can be just software, equipment, or both. And it takes place from the initial stage — prospecting for solutions — to the post-installation and complete operation stage, where everything needs to be recorded.

 

Such records aim for a series of documents to automatically validate the system for the operation that the institution requires. For Anvisa, exclusively online processes are considered a type of software, and for this reason, they must be validated. This is true even if they are not installed on any machine.