FDA’s Office of Biotechnology Products (OBP) regulates product quality (chemistry, manufacturing, and controls) of protein therapeutic products indicated for human use for the American public. OBP conducts laboratory-based studies and investigations as part of it’s regulatory mission. These studies include investigation of pharmaceutical mechanisms of action, examinations of the relationship of product quality attributes to adverse events, and analyses of analytical methods and manufacturing failure modes. To more efficiently achieve governmental digital document standards and collaborate with other internal stakeholders, OBP requires acquisition and support of electronic lab notebook (ELN) software. An ELN sytem will allow OBP to greatly reduce or eliminate paper-based records, digitally document results with 21 CFR part 11 compliant electronic signatures and audit trails, and collaborate seamlessly with collaborators in CDER.
The SciNote ELN or the equivalent software salient characteristics shall consist of the following:
- support local (on premises) installation on local virtual servers
- be browser-based and should support Chrome and Edge functionality.
- have audit trails (system, records, data, etc.)
- meet the standards of ISO 17025
- not have any client-side plugins (Java, etc.)
- have support for Single Sign-on
- be able to provide a workflow or system that allows for electronic supervisor review and approval of experiments
- be able to require that all records must have time and date stamp
- be able to create experiments that have versioning
- have basic project management capabilities including the ability to assign tasks to users, assign due dates, monitor the progress of tasks, etc.
- have the ability to generate a single report (section of package) from multiple experiments within a project or multiple reports from a single experiment (e.g., a summary report from project by a lead analyst)
- have the ability to track, via audit trail, when external reports are generated by the ELN
- include the ability to create project, workflow, and task templates
- provide Forms, fields, and tagging functionality
- have the ability to customize the User Interface (UI) (background color, text size, icon size, 508 compliant)
- provide the ability to share experiments (organized by project, user permission to read other’s projects, only comments)
- provide analysts/administrators with the ability to leave comments (trackable, history)
- have the ability to provide robust collaboration functionality (resolved button, or equivalent function, required)
- be able to preserve dynamic data (hotlink)
- have the capability to have automatically populated fields by pulling information from local databases
- have the capability to work with/access multiple databases (Internal FDA system, FACTS, DARRTS, STARLIMS)