User:Shawndouglas/sandbox

Sandbox begins below

1.1 Evaluation demonstration requirements

a. The solution must be available for full demonstration (preferably online), and the provider must be able to conduct an on-site demonstration. Explain your ability to meet these conditions.

1.2 IT requirements

1.2.1 IT General

a. Single database that supports multiple laboratory sites and laboratory departments

1.1 Evaluation demonstration requirements Functional requirement Requirement code Notes a. Available for full demonstration (preferably online) and provider able to conduct an on-site demonstration 1.2 IT requirements 1.2.1 IT general Functional requirement Requirement code Notes a. Single database that supports multiple laboratory sites and laboratory departments b. Client passwords encrypted in database with support for multi-case and special characters c. Secured Socket Layer (SSL) encryption on web client interface d. System designed so upgrades to back-end database do not require extensive reconfiguration or effectively cripple the system e. System provides all secured users access to its data via the Internet, LAN, or direct modem connection f. LIMS database conforms to Open Database Connectivity Standard (ODBC) g. All LIMS system files capable of having security applied to them h. All servers and workstations accessing LIMS system have login security i. LIMS able to use TCP/IP as its network transport j. Sized to not be impacted by multiple users or failover processes k. Archive utility without off-line l. System provides a workstation and server authentication mechanism m. System provides local restore capability without support intervention n. System Interfaces with database using ASP/ASP.net o. System able to maintain transactional history 1.2.2 Hardware environment Functional requirement Requirement code Notes a. System compatible with the hardware environment 1.2.3 Software environment Functional requirement Requirement code Notes a. System utilizes a non-proprietary database such as Oracle or Microsoft SQL Server b. System compatible with the software environment 1.3 Regulatory compliance requirements Functional requirement Requirement code Notes a. LIMS has security consistent with 21 CFR Part 11 and 40 CFR Part 3; system has security to enter the system, settable automatic logouts, periodic requirements for mandatory password changes, limits on reusability of passwords, and full electronic signature; provides a single point of access for all programs associated with the system for ease of administration and use b. Audit trail and specifications violation trails maintained; audit trail includes result changes, header information changes, as well as the user, date/time, and a required reason for the changes as a standard part of the application c. System maintains an audit trail of all data manipulation, consistent with all applicable regulations and standards d. System provides user selectable NELAP-compliant internal chain of custody that tracks all samples and associated containers from the time they are collected until disposed of e. System meets all standards of The NELAC Institute f. System provides persistent auditing capabilities g. System meets government requirements for handling classified information and documents h. System includes automatic date and time stamping i. System provides the ability to insert/manage secure electronic and/or digital signatures j. System supports ISO/IEC 17025 k. System supports 21 CFR Part 11 l. System supports 40 CFR Part 3 m. System supports HIPAA requirements n. System supports GALP and/or GAMP standards 1.4 General functional requirements 1.4.1 General Functional requirement Requirement code Notes a. Tracks status and workflow of the accession throughout the laboratory lifecycle, from submission to final analysis, including receiving, diagnostic testing, diagnostic test result reporting, and billing b. System supports barcoded specimen labeling and tracking c. System supports multiple customer payment sources (e.g. grants} d. System can track current status of diagnostic tests in an accession e. System contains spell-check dictionary that allows authorized users to add, edit, or remove entries f. LIMS includes system administration ability to reset user passwords g. LIMS can interface with or import existing data h. LIMS can be configured to meet the characteristics of the laboratory i. Optional comprehensive set of test codes suitable for use by the purchasing facility j. Vendor provides a support schedule for the implementation process, including optional levels k. Vendor can detail the amount of time and staff that purchaser will have to provide for the implementation process l. Vendor can explain function and availability of additional support capabilities m. System capable of storing multiple sample-related objects such as pictures, documents, PDF files, etc., including any instrument-generated format outputs from equipment n. System capable of storing sample comments, special information fields which are project- or sample-specific, user defined fields, data objects like scanned chain of custodies and digital photos of such items as sample events, bitmaps, movies, .wav audio files, and Word documents o. User able to store object files such as pictures from microscopes, GCMS scans of peaks, or even raw data files from instrument runs for later processing p. LIMS provides non-LIMS trained personnel access to the LIMS data via a simple Windows-type browser interface which permits the display of data from sample points, projects, or user-defined queries q. System provides for application-based security by limiting external users to functions they are password-privileged to perform r. System provides sample tracking from login through final reporting and invoicing