The Regulation
FDA’s Electronic Records and Electronic Signatures Rule (“Part 11”) defines the requirements for submitting documentation to the FDA in electronic form, as well as specifying the criteria for use of electronic signatures. These regulations, which affect the creation, maintenance, transmission, storage, modification and submission of electronic records, have added new challenges to the regulated life science industries. To verify conclusions you make from test data, the FDA wants to be able to use the same tools to evaluate data that you did. The FDA also requires that you can account for every detail as to how you arrived at your results. The key to such data evaluation and manipulation is a means to control the metadata — the data that software uses to render your data into meaningful reports.
Protein Metrics' Solution
Protein Metrics BYOSPHERE® software is CFR Part 11 compliant-ready. Designed to maintain and provide traceability for the instrument raw data, the associated metadata, and the processed data and reports, BYOSPHERE has the following features to enhance your Part 11 compliance program:
- Security, Access Limitations, and Authority Checks allow you to control which functions users are allowed to perform, and which folders, files, and Dashboards a user can access.
- Audit Trails: Granular, time-stamped records track any actions which create, modify or delete result files, ensuring traceability of all changes and updates.
- Electronic Signatures: When users are satisfied with their analysis report, they can electronically sign it. Signature states and transitions are customizable and managed within the Regulatory module.
- Record 'Approval' (locking) prevents unauthorized manipulation of metadata and reports. Mass spectrometry raw data can also be associated with metadata and reports, facilitating protection and traceability.
- Sophisticated Single Sign-On (SSO) enabled login, inactivity and session response timeouts, and many other features serve to help you ensure that your mass spectrometry data analysis is in full compliance with Part 11 regulations.
Available Features
| Versioning, custody & provenance tracking of all input files, raw files, and project files | YES |
| Automated reproducible analysis with robust LC-UV and LC-MS data integrations | YES |
| Enforced user logins & timeouts with access logs of any changes | YES |
| IdM verification for user authentication | YES |
| Fine-grained system permissions with defined user roles | YES |
| Audit trails for project actions from client application | YES |
| Audit trails for project actions from browser application | YES |
| Audit trail viewing and export | YES |
| Version control history of project and reports | YES |
| Electronic signatures for projects and reports | YES |
| Locking of signed/approved projects and reports | YES |
| Ability to lock and export PDF reports | YES |
| IQ/OQ documentation available (PQ services available for discussion) | YES |
Contact us to learn how you can rely on BYOSPHERE to meet your 21 CFR Part 11 compliance requirements.
In today’s regulated environments, it is more important than ever to ensure that your experiments meet the highest standards of traceability, reproducibility and accuracy.
Protein Metrics has all the tools and expertise to assist you in meeting your compliance requirements.