Process Compliance
When your processes are subject to Environmental Protection Agency or Food & Drug Administration audits, your records must be error-free and compliant with federal regulations. Ledger LIMS, by Simplicis, helps lab managers ensure their electronic records and electronic signatures are compliant with US FDA 21 CFR Part 11. Simplicis also provides ongoing support, including system maintenance and integration services, so lab operations can scale easily without compromising data and sample integrity.
Understanding Out-of-Specification Results
The FDA has lengthy guidelines for the investigation of out-of-specification results. Ledger provides transparency throughout the workflow, allowing lab personnel to more easily identify the causes of OOS errors.
Simplicis can also assist in troubleshooting OOS errors by examining how components and software are exchanging information, and checking systems and components for malfunction or degradation.
Supporting Future Efforts
Labs are under increasing pressure to innovate and to increase efficiency. Working faster, however, can produce mixed results – in the rush to move a compound to the next phase of research, teams may overlook problematic data or other issues that could cause a compound or drug to fail in the development phase.
7 out of 8 compounds that reach the clinical testing phase will fail.*
The ability to restrict access to samples and data, and a reconciliation function that ensures results match the initial order instructions are just a few of Ledger’s checks-and-balances that prevent operator errors. Ledger’s full suite of controls and analytics enhance data governance and monitor processes for compliance deficiencies.
Simplicis creates solutions that allow labs to scale effectively. If you’re interested in strengthening your processes to support your long-term goals, contact us.
SOURCE: Seiffert, Don. (2014, Nov. 21). Tufts study: it takes eight drugs in clinical trials to get one approval. Boston Business Journal.