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 Vendor requirements Functional requirement Requirement code Notes a. Vendor offers full demonstration (preferably online) and can conduct an on-site demonstration b. Vendor provides optional comprehensive set of test codes suitable for use by the purchasing facility c. Vendor provides a support schedule for the implementation process, including optional levels d. Vendor can detail the amount of time and staff that purchaser will have to provide for the implementation process e. Vendor can explain function and availability of additional support capabilities f. Vendor has a consistent training methodology for training new users g. Vendor provides support during the "go-live" period between system validation/operational deployment and final acceptance/beginning of maintenance and support agreements h. Vendor provides design qualification documentation i. Vendor provides installation qualification documentation j. Vendor provides operation qualification documentation k. Vendor provides performance qualification documentation during implementation l. Vendor provides user, administrator, developer, installation, and reference manuals m. Vendor provides a gap analysis after initial system installation, identifying the deliverables or tasks remaining n. Vendor provides description of maintenance and support offered during and after implementation, including times and methods of availability, issue escalation and management, etc. o. Vendor provides a detailed project approach and project plan that includes the project team, timeline, deliverables, and risk and issue management procedures p. Vendor provides a table linking each deliverable to the corresponding user requirement specification it fulfills q. Vendor provides a reliable cost estimates and pricing schedules, including all products and services included in the scope of work r. Vendor supplies LIMS-specific training program curricula s. Vendor supplies information about their overall project approach, acknowledgement of the deliverables, time/schedule constraints, and any other criteria for the project 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. System 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. System capable of storing multiple sample-related objects such as pictures, documents, PDF files, etc., including any instrument-generated format outputs from equipment j. 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 k. 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 l. 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 m. System provides for application-based security by limiting external users to functions they are password-privileged to perform n. System provides sample tracking from login through final reporting and invoicing o. System produces internal chain of custody data to track individual sample containers and test results p. System eliminates (or significantly reduces) redundant data entry and paper trail q. System manages archived, paper-based laboratory records r. System has a screen print function s. System has an analyst communication log t. System has configurable role-based security u. System utilizes role-based presentation of menus and functions v. System has supervisor override of chain of custody w. System provides automatic logout based on keyboard or mouse inactivity x. System prompts users for a reason for changes to database record y. System allows authorized personnel to review audit logs z. System's numbering scheme allows for sub-numbering while maintaining parent-child relationships aa. Chain of custody is printable for items, cases, projects, and batches ab. System has inter-lab transfer function ac. System allows queries of legacy data ad. Audit log retains all data, prohibits any deletions, and allows user comments ae. System search engine permits multiple search criteria af. System permits remote access for users, system admins, and support agents ag. System supports the definition and maintenance of edit tables and lists ah. System allows modification of records by system admins, with audit trail ai. System allows entry, maintenance, and administration of customers, suppliers, and other outside entities aj. System links or embeds standard operation procedure (SOP) access ak. System provides single data entry, automatically populates other data fields, and remembers pertinent and relevant data so it doesn't need to be re-entered, selected, or searched for al. System provides an intuitive, user-friendly graphical user interface (GUI), consistent with Microsoft products am. System captures data from all laboratory processes, ensuring uniformity of statistical reporting and other electronic data shared with designated users of the data an. System provides data archival and retention functionality ao. System efficiently utilizes standardized data input points and enhanced individual workload tracking ap. System provides full database keyword and field search capability aq. System provides read-only access to contract laboratory results ar. System allows use of navigation keys to freely move from field to field as. System allows data tables to be sorted at. System issues sequential numbers for chain of custody au. System allows multiple users to connect simultaneously to contract lab av. System notifies users of events like the scheduling, receipt, and completion of tasks aw. System includes the ability to set up alerts via email ax. System includes the ability to search multiple databases ay. System supports multiple users entering data simultaneously az. Data migrated into system converts cleanly to allow for reporting of historical sample collection 1.4.2 Configuration and customization Functional requirement Requirement code Notes a. User can independently add fields without requiring reconfiguration of the system after routine upgrades and maintenance b. System supports customized screens with user-definable information specific to an analysis c. System allows addition of universal fields on all samples logged into the system at any time during or after implementation, while neither voiding the warranty nor requiring vendor review at a later date d. System can expand to accommodate a new discipline e. System can integrate additional printers and scanners f. System allows the system admin to create custom screens, apps, and reports g. System dynamically changes captions (labels) on system fields h. System has dynamically configurable limit periods and notification hierarchy i. System can be easily and efficiently modified to meet lab growth and changing business needs 1.4.3 Receiving and scheduling Functional requirement Requirement code Notes a. System creates and maintains an electronic accession record for each accession received b. Electronic accession records support digital picture and document uploads in standard formats c. System allows users to handle billable and non-billable tests on the same accession d. System supports tracking of shipping and receiving e. System can receive accession/analysis request information from web-enabled forms f. System can process automated uploading of field-derived sample collection data g. System supports a user-configurable, spreadsheet-style, templated multi-sample login without requiring additional programming h. Multi-sample login supports the modification of sample or sample batch information prior to actual login i. Multi-sample login supports ad-hoc samples not predefined in the sample point list j. System can print user-definable chain of custodies, worksheets, routing sheets, and custom labels upon login k. System creates, saves, and recalls pre-login groups for routine samples to simplify recurring logins l. System includes comprehensive sample scheduling, tracking, and sample flow management m. System provides a comprehensive view of all samples and projects in the system using a color-coded status view of the current and scheduled samples via user configurable templates without requiring additional programming n. System schedules routine samples on an hourly, daily, weekly, or monthly basis, allowing them to be enabled and disabled as a group o. System streamlines login of recurring sampling projects p. System supports automatic assignment of analysis requests q. System can generate a monthly sampling schedule from a schedule database q. System can generate labels for recurring samples and sample groups 1.4.4 Analysis and data entry Functional requirement Requirement code Notes a. System provides auto-commenting for common laboratory result comments b. System provides normal data range values for diagnostic tests c. System includes default input values for diagnostic tests d. System stores non-narrative textual results in searchable fields e. System's user interface displays visual indicator such as status icons to indicate a sample's status in the workflow f. System allows incorrectly inputted data to be corrected g. System able to fully manage all aspects of laboratory quality control as well as report and chart all quality control data captured in the lab h. System supports a variety of test protocols, each capable of storing test comments, test required, and special information like GCMS conditions or special objects associated with the test i. System provides for a single test code requiring multiple analytes as targets j. System supports and qualifies text-based tests j. System supports single-component tests such as pH, BOD, CD, etc. k. System allows user to specify a single-component, multi-component, or narrative text test or group of tests, which represent all tests required l. System allows QA/QC test to be easily created and associated with the primary analytical test m. System provides colored visual indication of previously entered data as well as new data associated with a single sample When a result is entered, with the indicator changing color if the value is out of specification n. System allows file transfer of data from instrument or user-generated files, with full on-screen review prior to database commitment o. System reads results from previously entered tests to calculate a final result and immediately displays the calculated result p. System permits result entry via intelligent instrument interfaces or multi-sample/multi-test ASCII files q. System provides high-volume multi-component transfer of results with ability to automatically match samples to data files in either a backlog mode or a designated file mode, to parse the data, and to review and commit the sample data. r. System checks data files for specification and corrects them for specific reporting and analyte limits and qualifiers like dilution factor, automatically assigning qualifiers based on project analyte limiting s. System allows on-screen review of the stored result, diluted result with corrected MDLs, and qualifiers after running samples for multiple dilutions such as GCMS t. System stores test-related analysis comments with the test u. System displays the standard operating procedure (SOP) associated with each test result to ensure proper techniques are used v. System limits LIMS test code authorization to only qualified personnel and maintains their certification(s) to run assigned tests w. System uses a menu-driven process for results validation x. System's results validation process can access all information about a sample or group of samples, including comments or special information about the sample y. System allows authorized users to review all analytical results, including pricing, spec violations, history or trend analysis by analyte, and comments z. System validation screens check each result against its individual sample location specifications (both warning and specification limits) aa. System supports validation at the analysis and sample level, while also prohibiting sample validation when analysis validation is incomplete ab. System permits user-generated and modifiable Excel calculations on all tests ac. System automatically flags out-of-range quality control limits ad. System provides an overview of all outstanding analyses for better coordination of work schedules ae. System permits manual data entry into an electronic worksheet of test measurements and results af. System electronically transfers an item during testing from one functional area to another ag. System provides secure electronic peer review ah. System provides a base for a quality assurance program, including proficiency testing, scheduled maintenance of equipment, etc. ai. System allows automated or semi-automated data insertion aj. System updates sample/item status when tests are completed ak. System calculates monthly QA/QC percentages for testing al. System distinguishes between QA/QC duplicates and normal samples am. System distinguishes between routine and duplicate analysis an. System tracks changes in data structure and content ao. System allows user-friendly changes of data ap. System can validate/approve data prior to being moved to the main database 1.4.5 Instruments Functional requirement Requirement code Notes a. System bilaterally interfaces with instruments and related software b. System provides a database of preventative maintenance, calibration, and repair records for laboratory equipment, preferably supported by standardized reporting c. System downloads data directly from laboratory instruments d. System Schedules calibration/verification tasks in the worksheets or work flow process e. System permits the defining and exporting of sequences to instruments 1.4.6 External system interfaces Functional requirement Requirement code Notes a. System can direct output from ad-hoc queries to a computer file for subsequent analysis by other software b. System can exchange data with National Identification System (NAIS) tracking systems c. System provides a library of common and/or basic electronic data deliverable (EDD) formats d. System can transfer data to and from another record management system e. System supports dockable mobile devices f. System can import data from and export data to Microsoft Word, Excel, and/or Access g. System integrates with Microsoft Exchange services h. System can interface with contract laboratories to electronically retrieve datasheets, sample analysis, and other related information i. System can interface with non-Microsoft programs 1.4.7 Reporting Functional requirement Requirement code Notes a. System clearly differentiates released preliminary data from fully validated results b. System electronically transmits results via final report only when all case reviews have been completed by the case coordinator c. System can automatically post periodic static summary reports on an internal web server d. System provides ad-hoc web reporting interface to report on user-selected criteria e. System can transmit results in a variety of ways including fax, e-mail, print, and website in formats like RTF, PDF, HTML, XML, DOC, XLS, and TXT f. System supports multiple web browsers when viewing online reports g. System capable of creating QA/QC charts for all recovery, precision, and lab control samples via a full statistics package h. System includes several standard reports and query routines to access all samples with the pending status through a backlog report that includes the following criteria: all laboratory, department, analysis, submittal date, collection date, prep test complete, location, project, sample delivery group, and other user-selectable options i. System produces a read-only progress report that allows printed reports of sample status and data collected to date j. System automatically creates and transmits a separate exception report for all stored out-of-specification data k. System displays history of previous results for an analyte's sample point in a tabular report, graphic trend chart, and statistical summary l. System creates and transmits exception trails and reporting for all entered out-of-specification results m. System permits sample progress reports to be viewed locally or remotely based on security application limits and/or sample ownership n. System prevents a sample from being placed in a report queue until approved o. System includes a versatile report writer and forms generator p. System includes a custom graphic generator for forms q. System allows development of specific templates for different types of reports r. System can produce management and turn-around time reports and graphs s. System can produce customized final reports t. System can create and automatically update control charts u. System generates, stores, reproduces, and displays laboratory reports on demand, including narrative v. System generates, stores, reproduces, and displays laboratory, statistical, and inventory reports on demand, including narrative w. System can send on-screen output to printer or file x. System allow users to query and print chain of custody y. System supports report queries by fields/keys, status, completion, or other variables z. System prohibits issuing reports outside of qualified areas aa. System can generate reports from any data in tables ab. System uses Microsoft Office tools for formatting reports ac. System can automatically produce laboratory reports of findings and other written documents ad. System can automatically produce individual and aggregate workload and productivity reports on all operational and administrative activities ae. System can generate template letters for semi-annual reports af. System permits database access using user-friendly report writing and inquiry tools ag. System maintains template versions and renditions, allowing management and tracking of the template over time