LabCORE (See more at www.lab-core.com)

LabCORE, P-Wave's web-based document and workflow management application for FDA regulated industries, enhances a biomedical or pharmaceutical company's ability to manage and access a much greater variety of business documents as part of their LIMS (Laboratory Information Management System.) Previously, companies and laboratories needing to comply with the FDA's 21 CFR Part 11 regulation found LIMS products could only efficiently store electronic data points. As a result, graphic output such as chromatographs were stored in a manner that increased costs as well as complexity. Because LIMS' databases could only accept machine-readable data, human readable documents had to be printed out and maintained as hard copy.

LabCORE represents a major improvement over existing LIMS products because it can manage many file types and can efficiently collect, organize, store, and retrieve a wide variety of both machine and human readable related documents. As an add-on product to a LIMS, LabCORE enables the user to reduce costs while still maintaining a top quality document management system.

Customer Success:
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Product Highlights:

• Compliant with FDA's 21 CFR Part 11 requirements as well as related requirements for Gamp4, Good Laboratory Practices, Good Clinical Practices, Good Manufacturing Practices and the USEPA's Good Automated Laboratory Practices.
• Unlimited scalability for supporting thousands of users and managing millions of documents
• LabCORE's open architecture makes adding new features practical and cost-effective
• Integrates with LIMS and other applications, such as ERP, accounting, etc.
• Interfaces to Oracle, Interbase, MySQL, Microsoft SQL, PostgreSQL and Sybase
• Access to industry-standard authoring tools such as Microsoft Word, Excel and PowerPoint
• Ability to easily scan, capture, and store existing documents or data from a variety of sources including direct from laboratory instruments
• Powerful workflow automation for defining and automating business processes associated with creating, reviewing, approving, distributing and archiving documents
• Lifecycle management to identify and enforce the stages a document must pass through, such as document review, document approval and document publishing
• Full-text searching allows users to easily find and retrieve documents based on their contents
• Robust security, based on specific users and their roles, protects an enterprise's valuable knowledge contained in their managed documents.
• Flexible Storage System (FSFS) allows extremely large numbers of documents to be stored in multiple locations, yet centrally managed from LabCORE's hub.
• Custom Client allows for the creation and integration of customized user programs and specialized interfaces to facilitate document and records management.
• LabCORE uses a fully 21 CFR Part 11 compliant Electronic Signature capability, whereby several individuals can digitally sign a document.
• Searchable audit trail that logs and archives all actions performed within LabCORE, including editing, adding, viewing and signing a document.
• Learn more by visiting www.lab-core.com