Electronic Document Management with LabCORE™

FDA regulations require the electronic storage of all Laboratory Information Management Systems (LIMS) data for a period of seven to ten years. Current systems can only efficiently store electronic data points, and are reduced to storing graphic output such as chromatographs inefficiently. LabCORE, developed by P-Wave, Inc., represents a major improvement over existing products because it can manage many file types and efficiently organize and retrieve related documents.

LabCORE provides Electronic Document Management and workflow into a single enterprise class application that is FDA 21 CFR Part 11 compliant. Within LabCORE, data can be received from a variety of inputs such as scanned documents and electronic documents. LabCORE allows for customizable interfaces suitable for web-based access. It also offers role-based security, providing access to information based on an individual's role in the company. LabCORE provides complete traceability and audit tracking throughout the system. LabCORE creates a searchable format for document retrieval and can be integrated with P-Wave's other products, ProcedureCenter™ and TrainingCenter™, to create a full-featured, easily updateable system for a biotech company's knowledge assets.

Modules:

• Capture - captures documents from many sources including scanned pages, e-forms, email, application files and reports
• Storage - stores, manages and retrieves documents of all types including text, emails, pictures, graphics, audio, and video, in an internal database or externally on a file system
• Catalog - categorizes documents to enable easy search and retrieval using keywords, metadata, and full-text indexing
• Workflow - automates the routing and distribution of documents according to flexible business rules - Also allows version control of existing documents.
• Access - accesses documents via a browser, print, or native applications like Microsoft Office and XML
• Control - controls access to documents using role-based authentication with a complete audit trail noting who has accessed documents and when they were accessed

Features:

• Compliant with FDA's 21 CFR Part 11 requirements
• 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 P-Wave's ProcedureCenter and TrainingCenter 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
• 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.

For more information about LabCORE, contact:
Mark Ferrero
President
P-Wave Inc.
591 Canal Street, Suite 304
Reading, Pennsylvania 19602 USA
markf@p-wave.com
www.lab-core.com
+1.610.372.7890 x22