User:Shawndouglas/sandbox/sublevel7

An important part of many labs' concerns is compliance with the regulations and/or standards that apply to their particular areas of operation. These may be merely advisable in some cases, such as a commercial lab's marketability and competitiveness, or they may be mandatory, as in clinical labs for instance, where CLIA and HIPAA are the law, or environmental, water or wastewater labs who are regulated by the EPA.

One of the main reasons many labs even seek to employ a Laboratory Information Management System (LIMS) or Laboratory Information System (LIS - the term used more usually in medical labs) is in fact to help them make sure they meet the requirements of applicable regulations and standards, and to make audits much more simple and quick. LabLynx's LIMS/LIS, with the robust, enterprise-level ELab at its core, has always been an ideal solution for many reasons, and especially in this regard. In fact, it was initially developed in joint partnership with real-world regulated laboratories with compliance as one of its chief objectives.

Like previous versions of ELab, the current version supports all applicable regulations and standards, including:

• ASCLD
• NELAC
• 21 CFR Part 11
• 40 CFR parts 3, 6, 16, 29, 45, 50, 51 etc.
• CLIA
• HIPAA
• CAP
• GLP/GALP/GAMP/GCLP
• HL7
• Section 508
• ISO 17025, 9001 etc.
• ASTM
• IEEE
• ACS standards
• More...

LabLynx customers report tremendous satisfaction on the part of auditors when they discover ELab as the LIMS in operation. It provides exactly what they need, clearly and swiftly, documenting the processes that support applicable regulatory and standards compliance. Useful features include the Audit Trail function and Data Warehouse, as well as archived reports and complete sample records.

It is important to keep in mind that no matter how well any given application such as the LabLynx LIMS and LIS supports regulatory compliance, it is not the tool, but rather the users, whose actions determine compliance. Even the most fully compliant system cannot completely guarantee compliance. For instance, if standard procedures allow more than one person to login under a given username/password, then audit trail documentation is compromised. There are many ways any system can be undermined, so it is important that SOPs allow a regulatory-compliant system to meet compliance objectives.

There are additional resources to learn more about regulatory compliance and standards, both generally and specifically. LIMSbook.com is one very good source, along with LabCourses.com, all available through your sciCloud.net® community.