Configure e-signatures within protocols to govern approvals
Reviews are an important aspect of maintaining sample and result quality. To ensure that samples meet standard metrics, regulated laboratories have checkpoints that require review of work completed, either by a peer or a supervisor. Reviewed work is considered approved once the signature of the reviewer is recorded. In the past, paper records of such approvals via signatures were required to be stored and maintained by organizations to meet regulatory standards.
Now, to enable electronic labs, regulating agencies have published standards describing how electronic approvals or signatures can be recorded and maintained. One such regulation that describes the proper implementation of electronic signatures is 21 CFR Part 11 from the United States Food and Drug Administration.
BaseSpace Clarity LIMS electronic signatures and electronic record management is implemented fully to the FDA standard. Using e-signatures, labs can: