Compliance to the regulations of the US Food and Drug Agency (FDA) is essential for companies that manufacture chemicals, drugs, and medical devices for use in the United States. The exact FDA standards that are relevant to each company depends on the specific day to day operations and the final product. For example, a therapeutics company that has developed a novel diagnostic device must ensure that the kit validation data collected during a clinical trial meet FDA guidelines.
Since there are many regulations covering a wide range of activities and products, the FDA is organized into specific centers and offices that specialize in specific topics. In March 2019 the FDA announced a new operational organization in response to the rapid innovations taking place in the industries regulated by FDA. For example, the Center for Devices & Radiological health is responsible for ensuring compliance of medical devices.
This blog post focuses on regulations relevant to Electronic Lab Notebook (ELN) software packages (AKA Digital Lab Notebook). Organizations that use Electronic Lab Notebooks may be covered by different FDA centers. To create a unified set of standards that can be applied across different FDA centers, the FDA has published Part 11 for organizations that use a digital workflow for the storage of electronic records and electronic signatures.
Since the publication of Part 11, the FDA has been rigorously monitoring the compliance of organizations where Part 11 is applicable. For a more information about FDA Part 11 enforcement, request our whitepaper.
In the eyes of the FDA, software can also be considered a medical device. Algorithms and software packages that are intended to provide decision support for the diagnosis, treatment, prevention, cure, or mitigation of diseases or other conditions are considered medical devices. A recently released draft guidance by the FDA aims to provide clarity on the scope of FDA's oversight on software that is considered a medical device. Software products can be developed in-house or obtained from third party vendors. In addition a piece of software can be validated as a standalone product or as part of companion
Not all softwaare solutions used within the life sciences industry can be considered a medical device. For example a digital workflow for collecting and reporting clinical trial data may not be considered a medical device if the software solution is not capable of performing data analytics or diagnosis. Therefore, Electronic Lab Notebook software packages that are not capable of providing clinical decision support are not within the scope of regulations covering medical devices.
Here's 5 quick facts about the application of Part 11 regulation to Electronic Lab Notebooks:
1- Electronic Lab Notebooks can automate Part 11 compliance in organizations using digital records and electronic signature. For example, since we have verified that LabLog Electronic Lab Notebook meets the requirements of FDA Part 11, data inputted and maintained on LabLog™ may be submitted to the FDA under requirements of the Federal Food, Drug, and Cosmetic Act (e.g. as part of a New Drug Application). In addition, LabLog™ may be used to satisfy record and/or record approval requirements contained in FDA regulations (e.g. 21 CFR Part 58, Subpart G). Therefore, LabLog™ needs to comply with 21 CFR Part 11 requirements related to electronic records as well as electronic signatures.
2- FDA Part 11 ensures that your data is secure. To be Part 11 compliance, ELN solutions need to be verified as meeting specific data security and availability requirements. By adopting a Part 11 verified ELN, an organization can ensure data security without the need to perform ad-hoc validations. Part 11 compliance also ensures privacy and disaster recovery.
3- Audit trails are very important. In recently published guidelines for Part 11, the FDA has emphasized the important of audit trails. A robust audit trail system built into an ELN solution satisfies the data trustworthiness requirement of Part 11.
4- Electronic signatures must be securely generated for a predefined purpose. FDAPart 11 places extra emphasis on how electronic signatures are generated and manage within an ELN system. The signatures need to have a specific purpose and the ELN vendor ideally needs to show that all electronic signatures are securely generated to minimize the risk of fraud. In additions, electronic signatures need to be displayed on all printed and electronic versions of signed documents.
5- Access to ELN systems must be tightly controlled. Since the ultimate purpose of Part 11 is to ensure data security and trustworthiness, there is shared responsibility for ELN vendors and the individual organizations to ensure system access is controlled and any attempts at unauthorized access are promptly detected.
Since we have verified that LabLog Electronic Lab Notebook meets the requirements of FDA Part 11, data inputted and maintained on LabLog™ may be submitted to the FDA under requirements of the Federal Food, Drug, and Cosmetic Act (e.g. as part of a New Drug Application). In addition, LabLog™ may be used to satisfy record and/or record approval requirements contained in FDA regulations (e.g. 21 CFR Part 58, Subpart G). Therefore, LabLog™ needs to comply with 21 CFR Part 11 requirements related to electronic records as well as electronic signatures. Request a demo today to learn more.