Ledger LIMS

When laboratory processes are subject to audits by the Environmental Protection Agency or the Food & Drug Administration, maintaining error-free and compliant records is crucial. Ledger LIMS, developed by Simplicis, assists lab managers in ensuring that electronic records and signatures adhere to US FDA 21 CFR Part 11 regulations. Simplicis offers continuous support, including system maintenance and integration services, enabling labs to scale operations without sacrificing data and sample integrity.

Understanding Out-of-Specification Results

The FDA provides extensive guidelines for investigating out-of-specification (OOS) results. Ledger LIMS enhances workflow transparency, helping lab personnel identify the causes of OOS errors more efficiently. Simplicis also aids in troubleshooting these errors by analyzing the interaction between components and software, and by checking for system or component malfunctions or degradation.

Supporting Future Efforts

With the pressure on labs to innovate and boost efficiency, there is a risk of overlooking problematic data in the rush to advance compounds through research phases. Ledger LIMS includes features such as access restriction to samples and data, and a reconciliation function to ensure results align with initial order instructions. These checks-and-balances help prevent operator errors.

Ledger LIMS offers a comprehensive suite of controls and analytics to enhance data governance and monitor processes for compliance deficiencies. Simplicis provides solutions that enable labs to scale effectively, supporting long-term goals and ensuring robust process compliance.

According to a study by Tufts, seven out of eight compounds that reach clinical testing will fail, highlighting the importance of rigorous data management and compliance.