Life science organizations face a wide range of challenges today. The industry is increasingly competitive, for instance. Changing consumer demand, evolving audience demographics, price sensitivity – these are just some of the issues your organization faces. The Code of Federal Regulation (CFR) called 21 CFR Part 11 is that dictates how life sciences organizations handle electronic records and electronic signatures. We will link to the full text of the standard below.
You also must contend with increasing government regulation, such as 21 CFR Part 11, which deals with how your organization stores and accesses digital records, and the use of electronic signatures. Do those regulations apply to your learning management system? Absolutely, they do. However, the actual impact may not be quite what you expected. In this guide, we’ll take a look at what you should know.
What is 21 CFR Part 11?
21 CFR is a section of the Code of Federal Regulations. Part 11 specifically deals with:
- The use and storage of electronic records in all systems used within your business, including your learning management system
- The use, issuance, and control of electronic signatures in all systems used within your business, including your learning management system
According to the 21 CFR Part 11 full text and the subsequent clarifications and guidance offered by the FDA:
FDA considers part 11 to be applicable to the following records or signatures in electronic format (part 11 records or signatures):
- Records that are required to be maintained under predicate rule requirements and that are maintained in electronic format in place of paper format. On the other hand, records (and any associated signatures) that are not required to be retained under predicate rules, but that are nonetheless maintained in electronic format, are not part 11 records. We recommend that you determine, based on the predicate rules, whether specific records are part 11 records. We recommend that you document such decisions.
- Records that are required to be maintained under predicate rules, that are maintained in electronic format in addition to paper format, and that are relied on to perform regulated activities. In some cases, actual business practices may dictate whether you are using electronic records instead of paper records under § 11.2(a). For example, if a record is required to be maintained under a predicate rule and you use a computer to generate a paper printout of the electronic records, but you nonetheless rely on the electronic record to perform regulated activities, the Agency may consider you to be using the electronic record instead of the paper record. That is, the Agency may take your business practices into account in determining whether part 11 applies.
Accordingly, we recommend that, for each record required to be maintained under predicate rules, you determine in advance whether you plan to rely on the electronic record or paper record to perform regulated activities. We recommend that you document this decision (e.g., in a Standard Operating Procedure (SOP), or specification document).
- Records submitted to FDA, under predicate rules (even if such records are not specifically identified in Agency regulations) in electronic format (assuming the records have been identified in docket number 92S-0251 as the types of submissions the Agency accepts in electronic format). However, a record that is not itself submitted, but is used in generating a submission, is not a part 11 record unless it is otherwise required to be maintained under a predicate rule and it is maintained in electronic format.
- Electronic signatures that are intended to be the equivalent of handwritten signatures, initials, and other general signings required by predicate rules. Part 11 signatures include electronic signatures that are used, for example, to document the fact that certain events or actions occurred in accordance with the predicate rule (e.g. approved, reviewed, and verified).
How Does the 21 CFR Part 11 Full Text Apply to Your Learning Management System?
There are several obvious ways that 21 CFR Part 11 applies to your organization’s learning management system. These include:
- Electronic Records: Your LMS records and stores a very wide range of electronic records. These include things like employee training plans and schedules, test results, training analyses, and a great deal more.
- Electronic Signatures: Everyone who accesses your LMS must have their own electronic signature – the username/ID and password, combined with change-reasons and time/date stamps – that provide authorization for any actions taken or changes made within the system.
Does the FDA Really Care about Training Records?
Yes, the FDA can and will inspect your electronic training records. In fact, in many instances, training records are among the first inspected during a compliance audit. Therefore, it’s critical to choose an LMS that is built from the ground up with 21 CFL Part 11 in mind.
What Steps Must Be Taken?
The same steps need to be taken with your LMS as with any other electronic system your organization uses to record, store, or access digital records. These include:
- Validating: Validate the LMS to make sure that it is fit for your needs and usage scenarios. Make sure that the system’s features and capabilities match your requirements today, as well as in the future.
- Control Versions: You must have control over all versions of the courses contained within the LMS. Track revisions of content, new versions, training transcripts, and more.
- Auditing: Any change to data recorded by and stored in your LMS must include an audit trail that explains who, when, and why alterations were made.
- Reporting: You should have access to both granular and high-level information via built-in reporting tools within your LMS.
eLeaP Can Help
For most life science organizations, building an in-house LMS from the ground up to comply with the 21 CFR Part 11 full text is a daunting task. At eLeaP, we designed our groundbreaking LMS to provide all the functionality demanded by the FDA’s regulations and to empower you and your learners while simplifying compliance and delivering the quality training your team needs.