Does Your Digital Tools Help Your Lab Be FDA 21 CFR Part 11 Compliant?
That’s a critical question. Whether you’re selecting your first ELN/LIMS or evaluating the effectiveness of your current digital solution, you need to verify that it meets the United States Code of Federal Regulations (CFR) Part 11 as it applies to a pharmaceutical lab that produces and utilizes electronic documents and signatures. Since 1997, Part 11 of Title 21 of the Code, has been the primary authority governing the standard of practice for electronic records. Pharmaceutical laboratories that plan on adopting digital solutions for documentation should ensure that the ELN or LIMS solution they are selecting is one that is FDA 21 CFR part 11 compliant.
In this article, we explain several key provisions of FDA 21 CFR Part 11 and answer commonly-asked questions.
What made 21 CFR Part 11 a necessity?
Advances in hardware and software technology made electronic records easier and faster to create and maintain than paper records validated with ink signatures. Electronic records saved labs time and money. However, regulatory agencies needed the means to ensure that electronic records and electronic signatures were as accurate and trustworthy as paper and ink documents. Thus, 21 CFR Part 11 was drafted and approved in 1997.
What are the operational purposes of 21 CFR Part 11?
The operational purposes of 21 CFR Part 11 focus, first, on granting access to documents only to authorized individuals who are properly identified and who meet access requirements. The second purpose of 21 CFR Part 11 is to safeguard data integrity by creating strong security measures that include strict password, login, and electronic signature protocols as well as a clear audit trail that monitors all changes to a record and enhances a lab’s ability to catch errors or detect unauthorized access to any document.
Which industries need to comply with 21 CFR Part 11?
There are a few exceptions, but generally, US companies that manufacture pharmaceuticals, food products, or medical devices must adhere to 21 CFR Part 11.
What are the 3 main parts of 21 CFR part 11?
General provisions. This section lays out the overall scope of the regulation and explains the types of documents to which it pertains.
Electronic records. Section 2 of 21 CFR part 11 establishes the requirements that electronic record-keeping systems must meet to be compliant. This section focuses on the necessity of 1) establishing and maintaining a traceable link between records and the signatures on them and 2) avoiding having the same signature on multiple documents. It also addresses the requirements for managing the security of documents and providing an audit trail in either a closed software system – one in which the people who control the content of the electronic records also control access to them – or an open software system, in which people other than those responsible for the content of electronic records control the access to them. Either way, part 2 mandates that all records include the printed name of the signatory and the date and time. Additionally, each signature must specify the meaning (role) connected to it, such as review or authorship.
Electronic signatures. The third section sets out specific requirements that electronic signatures must meet to comply with 21 CFR Part 11. Included among the provisions are verifying each person’s identity and assigning each individual a unique signature. The Code also stipulates that each electronic signature 1) has a unique code and password, and 2) is used only by an individual, not a group of individuals such as a department or a work team.
What qualifies as an “electronic document”?
The wording of Part 11 is comprehensive and includes “any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.”
Note that 21 CFR part 11 applies to:
Much more than text documents. A picture, graph, or chart falls under part 11. So does an audio file.
“Any combination” of files a company intends to submit electronically to the FDA. A photo attached to a hand-written file and then electronically submitted to the FDA must comply with section 21.
The whole “life” of the document. Any file created with a computer system falls under 21 CFR purview. So does every iteration of the file, regardless of how many times it is “modified, maintained, archived, retrieved or distributed.”
Any record–even a single file. Even if your company creates only one electronic document, you’re obligated to comply with 21 CFR Part 11.
How does the SciCord Informatics Platform help you be 21 CFR Part 11 compliant?
SciCord is a spreadsheet-based Informatics Platform that combines the compliance and structured aspects of a Laboratory Information Management System (LIMS) with the flexibility of an Electronic Laboratory Notebook (ELN). The ELN and LIMS functions integrate seamlessly and enable your company to quickly reap the benefits of enhanced data and time efficiencies as you continue to meet compliance standards and follow GLP.
SciCord utilizes the ALCOA+ model to ensure consistent data security and data integrity. The 9 components of the ALCOA+ model ensure that all captured data is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available.
The Attributable component of ALCOA+ is particularly relevant to 21 CFR Title 11 compliance. SciCord provides a comprehensive set of roles predefined with permissions. These permissions can be configured to suit your lab. You can also create custom roles as needed.
Records are easily traced to the person who collected the data, the place of origin, and the time of data collection. Unique electronic signatures identify individuals who create or modify the electronic records. An audit trail includes the author or modifier of the data, the timestamp of the original and modified data, and the location of the data within the system.
All of these features help you enforce your organization’s policies and compliance commitments. They also indicate that the SciCord Informatics Platform is designed fully compliant with CFR 21 Part 11, has passed FDA audits, and is suitable for GxP use.
Summary
Complying with all the requirements of 21 CFR title 11 can be tedious unless you have a robust ELN or LIMS solution in place. The specifications regarding the safety and integrity of electronic records, including electronic signatures and an audit trail, can be onerous.
The SciCord Informatics Platform solution meets all the 21 CFR Title 11 compliance requirements and provides a hybrid solution for data integrity and safety.
