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The intention of this document is 1. to assist labs searching for a laboratory informatics product with identifying their system needs and 2. to help labs better determine if a specific vendor/product meets their requirements in the form of a request for information (RFI). The idea is to allow users to incorporate a standardized specifications sheet in their comparison of various laboratory informatics products.

This questionnaire lists the extensive requirements of a scientific data management system (SDMS). It attempts to be comprehensive and includes many items that do not apply to every lab. Additionally, some laboratories' requirements include a functionality item not common to other labs. The last section, 1.7 "Custom functions," is designed for the vendor to insert any additional functionality that doesn't fall under the categories provided.

When referencing a particular item for someone else, use the section number followed by the requirement letter, e.g. 1.4.2.f for "Does your system allow the administrator to create custom screens, applications, and reports? Please give details."

Requirement code and notes

In responding to each requirement, the vendor must select a requirement code from the following:

• Y: Meets requirement in commercial off-the-shelf solution as delivered/configured (or vendor provides service)
• YC: Meets requirement only with customization (additional code, using a third-party application, etc.)
• N: Does not meet requirement
• I: Informational response only, N/A

The vendor should ideally enter a requirement code and a response for each functionality question.

Printing or saving

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Note: Tables are currently not being rendered in PDFs as we like through the MediaWiki Collection extension. While we sure would love for you to make a PDF of this document, be warned: the tables don't format as intended, using either the "Create a book" or "Download as PDF" processes. For now you're best off selecting "Printable version" and printing that instead.

1.0 Vendor information

1.0 Vendor information Company name Physical address Website LIMSwiki web page Contact name and title Contact e-mail Contact phone and fax Years in business

1.1 Vendor services

1.1 Vendor services Request for information Requirement code Vendor response a. The vendor offers an online demonstration and/or an on-site demonstration. b. The vendor provides a detailed project approach and plan that includes the project team, timeline, deliverables, and risk and issue management procedures. c. The vendor explains their overall project approach, acknowledgement of the deliverables, time/schedule constraints, and any other criteria for the project. d. The vendor provides reliable cost estimates and pricing schedules, including all products and services in the scope of work. e. The vendor details the amount of time and staff that purchaser will have to provide for the implementation process. f. The vendor can explain the maintenance and support offered during and after implementation, including times and methods of availability, issue escalation and management, etc. g. The vendor provides a support schedule for the implementation process, including optional support levels and their function and availability. h. The vendor provides support during the "go-live" period between system validation/operational deployment and final acceptance/beginning of maintenance and support agreements. i. The vendor provides a gap analysis after initial system installation, identifying the deliverables or tasks remaining. j. The vendor provides a table linking each deliverable to the corresponding user requirement specification it fulfills. k. The vendor uses a consistent training methodology for training new users. l. The vendor supplies SDMS-specific training program curricula. m. The vendor provides user, administrator, developer, installation, and reference manuals. n. The vendor provides design qualification documentation. o. The vendor provides installation qualification documentation. p. The vendor provides operation qualification documentation. q. The vendor provides performance qualification documentation during implementation. r. The vendor provides well-documented system upgrades that authorized users can independently install. s. The vendor provides source code for the system. t. The vendor provides an optional comprehensive set of test codes suitable for use by the purchasing facility.

1.2 Information technology

1.2.1 General IT 1.2.1 General IT Request for information Requirement code Vendor response a. The system operates with a traditional client-server architecture, with software installed on each machine that needs to access the system. b. The system operates with a web-based interface, hosted on a server and accessed via a web browser on most any machine. c. The system contains a single, centralized database that supports multiple sites and departments. d. The system's database conforms to the Open Database Connectivity Standard (ODBC). e. The system is designed so upgrades to the back-end database do not require extensive reconfiguration or effectively cripple the system. f. The system is designed to not be impacted by multiple users or failover processes. g. The system applies security features to all system files. h. The system applies login security to all servers and workstations accessing it. i. The system provides a workstation and server authentication mechanism. j. The system applies Secured Socket Layer (SSL) encryption on the web client interface. k. The system encrypts client passwords in a database, with support for multi-case and special characters. l. The system uses TCP/IP as its network transport. m. The system contains an archive utility that doesn't require off-line mode. n. The system provides local backup and restore capability without support intervention. o. The system maintains the transactional history of system administrators. q. The system architecture is modular or extensible, facilitating the addition of new functionality. 1.2.2 Hardware environment 1.2.2 Hardware environment Request for information Requirement code Vendor response a. The system proves compatible with a variety of hardware environments. b. The system can be utilized with a touch-screen. 1.2.3 Software environment 1.2.3 Software environment Request for information Requirement code Vendor response a. The system utilizes a non-proprietary database such as Oracle or Microsoft SQL Server. b. The system proves compatible with a variety of software environments.

1.3 Regulatory compliance and security

1.3.1 Regulatory compliance 1.3.1 Regulatory compliance Request for information Requirement code Vendor response a. The system supports 21 CFR Part 11 and EU Annex 11 requirements, including login security, settable automatic logouts, periodic requirements for mandatory password changes, limits on reusability of passwords, and full electronic signature. b. The system supports USP <232>/<233> requirements. c. The system supports GALP and/or GAMP standards. d. The system maintains date- and time-stamped audit trails of all data manipulation — such as changes to results, data analysis parameters, and methods — as consistent with all applicable regulations and standards, making the information available for review, copying, and reporting to authorized users. e. The system's audit log retains all data, prohibits any deletions, and allows user comments. f. The system maintains audit trails at least as long as the records to which they pertain. g. The system provides additional persistent auditing capabilities, such as the audit of cancelled uploads and scheduled system functions. h. The system provides the ability to both automatically and manually add secure electronic signatures to documents and other data. 1.3.2 Security 1.3.2 Security Request for information Requirement code Vendor response a. The system allows administrators and other authorized users to configure multiple levels of user rights and security by site location, department, group, role, and/or specific function. b. The system allows administrators and users to reset user passwords. c. The system features and enforces adjustable rules concerning password complexity, reuse, and expiration. d. The system can lock a user out after a specified number of consecutive failed login attempts. e. The system provides the option for automatic user logout based on keyboard or mouse inactivity. f. The system makes authority checks to ensure only authorized individuals can use the system to perform an operation. g. The system allows authorized users to modify records, while also maintaining an audit trail of such actions. h. The system prompts users to declare a reason for making changes to data in the system. i. The system allows authorized users to manually delete records, while also maintaining an audit trail of such actions. j. The system allows authorized users to generate a detailed user access record. k. The system provides email notification of lockout, security access, and improper workstation access. l. The system provides a mechanism to allow a user read-only access to stored data. m. The system allows automatic and/or manual holds or locks to be placed on data to ensure it goes unaltered or remains retrievable during a retention period. n. The system can first feed data from connected non-CFR-compliant instruments through a virtual environment that is compliant (audit trailed, secure, versioned, etc.) before being stored.

1.4 General system functions

1.4.1 General functions 1.4.1 General functions Request for information Requirement code Vendor response a. The system offers non-SDMS trained personnel the ability to easily access system data via an intuitive, user-friendly Windows-type graphical user interface (GUI) which permits the display of stored data. b. The system allows authorized users to configure their GUI to a specific language, character set, and time zone. c. The system permits remote access for users, system admins, and support agents. d. The system allows for the use of navigation keys to freely move from field to field. e. The system allows data tables to be sorted. f. The system can send on-screen output to a printer or file without contradicting view-only statuses. g. The system supports multiple instruments and users entering data simultaneously. h. The system contains one or more spell-check dictionaries that allow authorized users to add, edit, or remove entries. i. The system provides full metadata, keyword, and field search capability, including the use of multiple search criteria. j. The system allows users to search for similar records based upon a set of metadata tag values. k. The system allows users to build, save, and edit queries for future use. l. The system interfaces with or imports existing data from other systems and/or databases. m. The system provides data archival and retention functionality for electronic laboratory records. n. The system allows users to associate and store both sample- and non-sample-related objects such as images from microscopes, GCMS scans of peaks, PDF files, spreadsheets, or even raw data files from instrument runs for later processing. o. The system can store media objects like digital photos, bitmaps, movies, and audio files. p. The system can link objects to other objects, e.g. linking a standard operating procedure (SOP) to a test result. q. The system notifies users of events like the scheduling and completion of tasks. r. The system includes the ability to set up alerts via email. s. The system offers integrated or online user help screens? 1.4.2 Configuration and customization 1.4.2 Configuration and customization Request for information Requirement code Vendor response a. The system can easily and efficiently be modified to meet lab growth and changing business needs. b. The system has an application programming interface (API) or a similar software development toolkit (SDK). If web-based, the API should support Simple Object Access Protocol (SOAP), representational state transfer (REST), or both. c. The system allows a user to independently add fields without requiring reconfiguration of the system, even after routine upgrades and maintenance. d. The system allows for the integration of additional printers and scanners both locally and externally. 1.4.3 Receiving and scheduling 1.4.3 Receiving and scheduling Request for information Requirement code Vendor response a. 1.4.4 Analysis and data entry 1.4.4 Analysis and data entry Request for information Requirement code Vendor response a. o. Does your system allow file transfer of data from instruments via intelligent interfaces or multi-sample/multi-test ASCII files, with full on-screen review prior to database commitment? p. Does your system permit manual data entry into an electronic worksheet of test measurements and results? q. Does your system allow incorrectly inputted data to be manually corrected? 1.4.5 Post-analysis and validation 1.4.5 Post-analysis and validation Request for information Requirement code Vendor response a. c. Does your system read results from previously entered tests to calculate a final result and immediately display the calculated result? e. Can your system graphically display the results of one or more tests in a graph (normalized or otherwise) for the purpose of visualizing data or searching for possible trends? g. Does your system display the standard operating procedure (SOP) associated with each test result to ensure proper techniques were used? h. Does your system store test-related analysis comments with the test? q. Does your system validate/approve data prior to being moved to the main database? v. Does your system allow manual entry of QA and QC data not captured as part of the system's regular processes? 1.4.6 Instruments 1.4.6 Instruments Request for information Requirement code Vendor response a. The system bilaterally interfaces with instruments and related software based on the Unix and Windows platforms. b. The system can download data directly from laboratory instruments. c. The system can track and report on the usage of attached laboratory instruments. d. The system can automatically (or manually allow an authorized user to) remove an instrument from potential use when it falls out of tolerance limit or requires scheduled calibration. e. The system maintains a reportable database of preventative maintenance, calibration, and repair records for attached laboratory instruments. f. The system can schedule calibration, verification, and maintenance tasks on attached instruments and make that schedule available for viewing. g. The system allows users to create and edit instrument maintenance profiles. 1.4.7 External system interfaces 1.4.7 External system interfaces Request for information Requirement code Vendor response a. The system supports a library of common electronic data deliverable (EDD) formats. b. The system can transfer data to and from other record management systems. c. The system integrates with Microsoft Exchange services. d. The system can import data from and export data to Microsoft Word, Excel, Access, and/or Powerpoint. e. The system can interface with non-Microsoft programs. f. The system can interface with enterprise resource planning (ERP) systems. g. The system can interface with internal and external laboratory systems like laboratory information management systems (LIMS) and electronic laboratory notebooks (ELNs). h. The system can leverage the application programming interface (API) of other systems to establish integration between systems. i. The system provides a real-time interface for viewing live and stored data transactions and errors generated by interfaced instruments and systems. j. The system supports dockable mobile devices and handles information exchange between them and the system. k. The system supports the use of optical character recognition (OCR) software. 1.4.8 Reporting 1.4.8 Reporting Request for information Requirement code Vendor response a. The system includes a versatile report writer and forms generator that can generate reports from any data in the system. b. The system can interface with a third-party reporting application. c. The system allows the development of custom templates for different types of reports. d. The system maintains template versions and renditions, allowing management and tracking of the template over time. e. The system uses Microsoft Office tools for formatting reports. f. The system can indicate whether a report is preliminary, amended, corrected, or final while retaining revision history. g. The system can automatically generate laboratory reports of findings and other written documents. h. The system provides an ad-hoc web reporting interface to report on user-selected criteria. i. The system can automatically generate and post periodic static summary reports on an internal web server. j. The system can transmit reports in a variety of ways including fax, e-mail, print, and website in formats like RTF, PDF, HTML, XML, DOC, XLS, and TXT. k. The system includes a rules engine to determine the recipients of reports and other documents based on definable parameters. 1.4.9 Laboratory management 1.4.9 Laboratory management Request for information Requirement code Vendor response a. The system allows the creation, modification, and duplication of user profiles. b. The system provides document workflow management tools for streamlining their creation, review, modification, and approval.

1.7 Custom requirements

1.7 Custom requirements Request for information Requirement code Vendor response a. b. c. d. e. f. g. h. i. h. i. j.