21 CFR Part 11 applies to FDA-regulated industries. It requires that controls are put in place to ensure electronic records and signatures are accurate, authentic, trustworthy, reliable, confidential and equivalent to paper records and handwritten signatures on paper. These controls includes elements such as access control, data protection, system validations, audit trails and where applicable, electronic signatures control.
Functions and Options Relevant to 21 CFR Part 11
BD Biosciences offers several instruments and software with features such as password protection, electronic signatures and audit trails to support our customers with their 21 CFR Part 11 compliance.
BD FACSuite™ and BD FACSuite™ Clinical Applications are software used to operate the BD FACSLyric™ Flow Cytometer, acquire samples, and analyze the data. The BD FACSuite™ Clinical Application supports BD IVD assays with predefined assay templates. The BD FACSuite™ Application is designed for user-defined assays and collaboration through the unique assay transfer feature, providing simple, reproducible and transferrable assay setup facilitating instrument-to-instrument and site-to-site standardization. Both applications include password protection, audit trail, electronic signatures and IQ/OQ procedures, assisting in supporting 21 CFR Part 11 compliance and electronic record integrity.
The BD FACSDuet™ Premium Sample Preparation System is a comprehensive fully automated flow cytometry sample preparation system that offers automatic sample transfer through physical integration with the BD FACSLyric™ Flow Cytometer. It automates manual error-prone steps and helps automate sample preparation for both IVD and user-defined assays. It provides lab traceability with easy-to-pull reports of specimens, worklists and reagents to facilitate inventory and data management.
BD FACSDuet™ Sample Preparation System helps labs to be compliant with 21 CFR Part 11, including user management and password protection as well as audit trails.
BD Infinicyt™ Software is a standalone analysis software that offers a variety of classic features and several more-advanced capabilities, such as automated gating and identification. Automated gating is a key pillar in the Next Generation Flow™ technique, which standardizes the workflow of predefined assay panels from sample preparation to automated analysis and reporting. The software includes many security tools and features supporting 21 CFR part 11 compliance.
BD FACSLyric™ Flow Cytometer with the BD FACSuite™ Clinical and BD FACSuite™ applications, BD FACSDuet™ Sample Preparation System, BD FACSDuet™ Premium Sample Preparation System and BD Infinicyt™ software are in vitro diagnostic medical devices bearing a CE mark.
BD FACSLyric™ Flow Cytometer, BD FACSDuet™ Sample Preparation System and BD FACSDuet™ Premium Sample Preparation System are open systems for which CE-IVD applications have been validated by BD and the systems can also be used for user defined assays/ protocols which are to be validated by the user. Refer to the respective IFU for further details.