SOURCES SOUGHT
70 -- Electronic Laboratory Notebook is an essential requirement for planning and recording of data generated in the laboratory. This has fueled the development of software programs that can be termed and Electronic Laboratory Notebook (ELN).
- Notice Date
- 4/3/2009
- Notice Type
- Sources Sought
- NAICS
- 511210
— Software Publishers
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-ELN09-RFI
- Response Due
- 5/8/2009
- Archive Date
- 7/7/2009
- Point of Contact
- Cheryl Miles, 301-619-7148<br />
- Small Business Set-Aside
- N/A
- Description
- EXECUTIVE SUMMARY: The U.S. Army Medical Research and Materiel Command (USAMRMC) is the Armys medical materiel developer and logistician. Under this command structure, the MRMC has a number of institutes that conduct laboratory research science. The laboratory notebook is the primary document for planning and recording of data generated in the laboratory, consequently the proper maintenance of a laboratory notebook is an essential requirement for conducting research. However, the traditional paper laboratory notebook has become inefficient and ineffective for storage of all forms of data being collected in the modern research laboratory. This situation has fueled the development of software programs that can be termed an Electronic Laboratory Notebook (ELN) and are designed to completely replace paper forms of record keeping. ELN software available today features single entry of data from a wide range of electronic sources and storage of that data in a fully documented, patent compliant, retrievable form in an electronic database. This document details the requirements for ELNs to be used in the USAMRMC discovery research laboratories and the process to be used to evaluate vendors and vendors ELN applications for implementation into these laboratories. 1.0 PURPOSE AND SCOPE 1.1 Purpose The U.S. Army Medical Research and Materiel Command (USAMRMC) is the Armys medical materiel developer and logistician. The command has four major Core Capabilities: "Shape future medical solutions through research, advanced technology, and partnerships "Execute streamlined medical logistics, facilities and acquisition management "Develop, integrate, acquire and sustain medical IM/IT solutions "Provide best business practices and program management solutions The USAMRMC is the executive or lead agency responsible for: "The Medical Chemical and Biological Defense Research Program (MCBDRP) "Military Human Immunodeficiency Virus (HIV) R&D Program (Acquired Immune Deficiency Syndrome (AIDS)) "Military Infectious Diseases Research Program (MIDRP) "Global Emerging Infections Surveillance and Response System (GEIS) "Use of Investigational New Drugs for Force Health Protection "DoD Food and Nutrition Research, Development, Test, Evaluation, and Engineering Program "Combat Dentistry Research Program "Gulf War Illnesses/Force Health Protection Research Program "Peer Reviewed Medical Research Program (PRMRP) The USAMRMC conducts laboratory research at the following institutions "U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). "Walter Reed Army Institute for Research (WRAIR). "U.S. Army Medical Research Institute for Chemical Defense (USAMRICD). "U.S. Army Research Institute of Environmental Medicine (USARIEM) "U.S. Army Institute of Surgical Research (USAISR) "U.S. Army Aeromedical Research Laboratories (USAARL) "U.S.Army Center for Environmental Health Research (USACEHR) 1.2 Scope This Requirements Specification document is provided to the system owner (MRMC) as a high level statement of what the ELN must do, as defined by the unique user populations requiring a laboratory notebook record. This document will allow selection of a information technology capability which best meets the requirements. Although this document addresses several technical configuration requirements of the ELN, it concentrates on the business needs of the USAMRMC at this time. Maintaining a laboratory notebook is a necessary requirement for conducting experimental science. It is the primary document for planning and recording of data generated in the laboratory, it is the source of stored information for retrieval of data generated over time, and it is the primary document used to support a patent position in court or in an administrative proceeding before the U.S. Patent & Trademarks Office. Consequently the proper maintenance of a laboratory notebook is an essential requirement for conducting research, replicating and validating results, and securing proper recognition for our scientific accomplishments. This requirement is recognized by all investigators working in a research laboratory and investigators are trained in the proper method of maintaining a bound paper notebook. Such notebooks are issued by the institute, are the property of the institute, and are returned to the institute upon completion. Command and Institute policies as well as requirements to protect Intellectual property entail that paper notebook pages be numbered, that each page is signed and dated by the investigator, and that each page is counter signed and dated by an individual, not involved with the project, who is familiar with the technology and experimental approach. However, over the past two to three decades it has become increasingly evident that the bound paper notebook record cannot be inclusive when recording data in a modern biological and/or chemical laboratory. The data being collected is in diverse formats and some formats cannot be easily stored in a bound paper notebook. Examples include films showing radioactive images, an array of readouts from a variety (e.g. liquid and gas columns; stained and dried acrylamide gels; film and paper imaging) of chromatographic apparatus, animal telemetry readouts, databanks of information generated by projects involving nucleic acid sequence analysis, and screening data of chemical compound libraries. Due to their size or fragility, many of these sources of data require a storage location other than a notebook, incurring difficulties in documentation, storage location, and data retrieval. Bound paper notebooks require the attachment of printed copies of any electronic documents or images generated during laboratory data collection. Consequently, the paper notebook has become an inefficient and insufficient method of storing data. This fact is now better appreciated throughout the research and legal community and the long standing requirement for a bound paper laboratory notebook record for documenting intellectual property has been questioned. With the development of computer software for compiling all forms of electronic data, and with the acceptance of electronic signatures on most legal documents, the U.S., European, and world-wide patent offices have stated that electronic data, if properly stored and annotated, will be permitted as evidence in support of an intellectual property position (para 4.1). 2.0BUSINESS OBJECTIVE To evaluate the present status of ELNs for the chemical, biological, and medical research laboratories and determine if one or more can be implemented for use in the wider-range of MRMC laboratories, the following business questions must be addressed: 2.1General 2.1.1The System must interface with an Oracle database. 2.1.2 The System must be fully compatible with Microsoft programs using either the Windows or Apple platform. 2.1.3 The System must be accessed by CAC based security or by password based security when CAC access is not available. 2.1.4 The System must be able to track/retrieve key information such as project name, author, experimental method, date, and other keywords. 2.1.5 The System must have a capacity to lock-down data with a date-time stamp (version control). 2.1.6The System must maintain integrity of stored data, which cannot be compromised for at least 30 years (para 4.2). 2.1.7The System should have flexibility in supporting unstructured journal style information recording and allow user to revise the notes easily. 2.1.8The System should support handwriting recognition and content storage as both image and text. 2.1.9The System should support bidirectional data exchange integration with other data systems. 2.1.10The System must be web-based to facilitate remote access from within laboratory suites, access across command laboratories, and require no additional software (e.g. ActiveX, or Citrix). 2.1.11The System should be able to accept data from a Tablet PC, PDA, or other commonly used electronic communication devices. 2.1.12The System must have automatic or passive save page feature. 2.1.13The System should accommodate the use of Internet Explorer, Safari, and FireFox browsers. 2.1.14The System must be able to attach/embed high content data formats not limited to the following file extensions: gif, xls, txt, ppt, pzf, doc, png, and pdf. 2.1.15The System must be able to use English as the primary language. 2.1.16The System should have capability to produce output in PDF format. 2.1.17The System must allow real-time data access. 2.1.18The System should allow users to add data as it is available, not full page by full page (i.e. not require completion of a page prior to moving forward). 2.1.19The System should be, at a minimum, Internet Protocol version 6 (IPv6) compliant. 2.1.20The system should have a single screen that summarizes the open work tasks for each user. 2.1.21The System must utilize electronic signature of both notebook author and a second user witness (para 4.1). 2.1.22The System must be compliant with Section 508 of the Federal Rehabilitation Act (amended 1998) (para 4.3). 2.1.23The System should provide online help and be accessible to the system users. 2.2Data 2.2.1The System must accommodate notebooks with an unlimited number of pages. 2.2.2The System should allow for meta-data fields on files for exportation. 2.3Security and Regulatory Compliance 2.3.1The System should not leave information in the local machines cache, nor leave cookies on the local machine when in offline mode. 2.3.2The System must be compliant with U.S. Code of Federal Regulations (CFR) Title 21 part 11 to include: secure, computer generated, time-stamped audit trail recording operator entries and actions that create, modify or delete electronic records; ability to generate accurate and complete copies of records in both human readable and electronic form; authority checks to ensure only authorized individuals can use the system, electronically sign or alter a record.(para 4.1) 2.3.3The System must integrate into an https: web server using Secure Sockets Layer with 128 bit encryption. 2.3.4The System must allow configurable password expiration, password expiration notification, and logon attempt lock-outs. 2.3.5The System should provide the ability to alert administrators when unusual database activity occurs (i.e. security breaches, massive data deletion), or when database maintenance will be required. 2.4User Management 2.4.1The System must allow unique user permission levels based on roles and allow for the configuration of the permission levels. 2.4.2The System must allow different user rights and access for different studies. 2.4.3The System should be able to accommodate multiple users with the same roles and with the same access within a given study. 2.5Training 2.5.1The System should accommodate general system training by providing a training environment that is not linked to the live database. 2.5.2The System training must be provided in English. 2.5.3The System training must include role based training. 2.5.4The System training should be able to be conducted in the following formats: by Video Teleconference (VTC) and Instructor-Led. 2.6Database and Application Auditing / Compliance 2.6.1The System should provide the ability to track a baseline set of database events including user logins, schema modifications, connect times, and system updates. 2.6.2The System should provide the ability to create ad-hoc reports. 2.7Database Provisioning and Management 2.7.1The System should provide tools to conduct the following activities: 2.7.1.1 Database Management 2.7.1.2 Instance Management 2.7.1.3 Schema Management 2.7.1.4 Security Management 2.7.1.5 Storage Management 2.7.1.6 Workspace Management 5.7.1.7 System should support an Oracle 10g (or later) back end database 2.8Vendor Additional Requirements 2.8.1Vendor must transfer knowledge to the USAMRMC support staff to enable them to manage the IT related functions to support the system. This education plan must enable USAMRMCs rapid ownership of the system, including all setup and administrative functions required to support the system (para 4.4). 2.8.2Vendor must be able to support a full technology transfer of their software and utilities to the USAMRMC, which will result in the USAMRMC being capable of completely independent operation and maintenance (para 4.2). 2.8.3Vendor should demonstrate other components that are supported with their ELN 2.8.4Vendor must include in their licensing agreements a description of their responsibility for resolving any flaws in the licensed software. 2.8.5Vendor must include, in the development plans for their software and utilities, how a licensee will gain access to the new versions of the software over time. 2.8.6Vendor should be able to discuss how their help desk capability may be leveraged by the USAMRMC on a permanent or ad hoc basis. 2.8.7Vendor must include ared to demonstrate their software without requiring access to Department of Defense network. If vendor has the capability to access the internet through independent wireless network carriers they may do so at their own expense. 2.8.8Vendor must be prepared to demonstrate their capabilities at Fort Detrick, MD. 2.8.9Vendor must be able to host an audit by the USAMRMC Quality Management Office (QMO). 2.8.10Vendor must have available for review: Quality System documentation, System Development Lifecycle documentation, and Validation documentation during the audit. 2.8.11Vendor must be able to describe their problem resolution and escalation process. 2.8.12Support personnel for this system must be United States citizens. 2.8.13Vendor must be able to provide expert witness (reimbursable) to explain how system works and assure that data is accurate, fixed as of a certain date, and has not been altered. 3.0 EVALUATION CRITERIA The vendors system: 3.1 is user friendly; 3.2 meets all Business Requirements listed in this document; 3.3 accommodates user specific templates; 3.4 is adaptable to research MRMC research laboratories and scalable to enterprise level; 3.5 is able to operate in a 24/7 mode with minimal downtime. 4.0 REFERENCES 4.1 21 CFR Part 11; 37 CFR, Sections 41.152, 41.207; and Federal Rules of Evidence. 803(6), 901(a) and 1001(3). 4.2 U.S. Department of Defense (DoD) 5015.2-STD Electronic Records Management Software Applications Design Criteria Standard. 4.3 Section 508 of the Rehabilitation Act of 1973, as amended in 1998, 29U.S.C. 794(d). 4.4DOD 5200.28-STD; Department of Defense Trusted Computer System Evaluation Criteria Standard; DODI 8500.2, Information Assurance (IA) Implementation, included references and implementing agency regulations and policies. 5.0 Cost Estimates Please provide a rough estimate for implementing an MRMC ELN based on the following quantities and implementation schedule: Total Software Units Total Units 90Testing 3 6 Months 410Initial Implementation FY 10 915Mid-Term Implementation FY10 490Complete Implementation FY11 1905TOTAL
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- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD<br />
- Zip Code: 21702-5014<br />
- Zip Code: 21702-5014<br />
- Record
- SN01785048-W 20090405/090403220220-311922c8467422340ed3f63beebf3c5a (fbodaily.com)
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