LabFlow Software
LabFlow, LLC, an Invivoscribe company, is developing 21 CFR part 820 compliant software to integrate data, information, and provide real-time financials for multiple inter-dependent but independent companies, including foreign subsidiaries and distributors. This comprehensive ERP software package is built on the backbone of the commercial Microsoft Dynamics NAV product and requires approximately the same degree of customization, but its capabilities and features extend well beyond the limits of the MD NAV product. LabFlow helps manage and coordinate GMP manufacturing processes - from receipt of raw materials through batch records to finished goods - with full inventory management. This system allows our employees to track the transfer and sale of products to CLIA- and CAP-accredited clinical testing laboratories, foreign distribution centers, and other end users.
Real Value for Molecular Diagnostics' Businesses. Strict Guidelines; HIPPA Compliant
LabFlow's capabilities are of real value for businesses operating in the areas of personalized molecular medicine and personalized molecular diagnostics. The fully integrated system handles clinical specimens in a manner familiar to LIS and LIMS users, but internally these specimens are tracked as if they were raw materials within a rigorous GMP manufacturing environment. Patient samples are tracked with chain of custody, from specimen receipt and accessioning, through specimen processing, test setup, test interpretation, results reporting, and archiving of amplified products and residual material. All specimens, data and clinical results are handled compliant with HIPPA and international standards to ensure patient confidentiality.
R&D Management
R&D activities are managed under design control, from feasibility, IP assessment, to transfer and acceptance of final manufacturing and QC specifications by our manufaturing group in production.
February 2010 Launch
The first fully integrated business package was launched on February 1, 2010. We anticipate that a commercial package will be available for customers 1Q 2011. LabFlow incorporates 21 CFR 820 compliant business processes into workflow. The software can be configured so that compliance is required to move manufacturing and other processes through the system; making it impossible to proceed until all required steps have been completed and digitally signed off on by authorized second person(s). Authorized accounts can be set up with expiration dates to ensure that those with signature authority are current in their training and with all other compliance requirements. Despite the range of features, this package requires minimal customization, is scalable with minimal IT support, and will integrate with a majority of LIS, LIMS, and business packages.