General Information: Document Type: Sources Sought Release Date: March 20, 2012 Response Date: April 3, 2012 at 10:00 am EST via e-mail to Contract Specialist: Vida Niles at Vida.Niles@fda.hhs.gov Description: Computer Data Integrity Training on Data Audit Enforcement This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantage businesses, HUB Zone businesses; veteran-owned small businesses, and women-owned small businesses). This notice is being posted for fact finding and planning purposes only and shall not be construed as an Invitation for Bid, a Request for Proposal, Solicitation, Request for Quote, or an indication the Government will contract for the items or services herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The Government does not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this source sought. Any response received will not be used as a proposal. NAICS CODES: 541690 No official solicitation currently exists in connection to this request for information (RFI). Also, if in the future an official solicitation is released, there is no guarantee that sources responding to this RFI will be included on the source list. **QUESTIONS WILL NOT BE ENTERTAINED AS A RESULT OF THIS NOTICE** The Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), Division of Acquisition Operations (DAO) is seeking to identify sources with capabilities and prior experience in training in detecting computer fraud. FDA makes no implied or in fact contract by issuing this Sources Sought. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Material that requires a non-disclosure agreement or that may be business sensitive will not be accepted. Please note that responses to this notice will not be returned. Project Title: Computer Data Integrity Training on Data Audit Enforcement Background The requirement for the validation of electronic systems in the regulated pharmaceutical industry brings challenges of how to apply the requirements to preserve integrity of data for manufacturing, testing and laboratory analysis. Audit trails maintain a record of system activity both by system and application processes and by user activity of systems and applications. In conjunction with appropriate tools and procedures, audit trails can assist in detecting security violations, performance problems, and flaws in applications. The FDA needs to create a clear approach on where scrutiny and enforcement are needed. The Office of Compliance needs to improve its understanding in how best to regulate electronic records, provide strategies and practical recommendations, including additional guidance and policies that may be needed. Objective The Office of Compliance seeks to procure the services of a contractor that has proven experience, expertise, knowledge and abilities to provide training to the Office of Compliance staff, especially the Office of Manufacturing and Product Quality and the Office of Scientific Investigations to determine how best to apply the requirements to address data audit integrity, archiving, the data transfer of information (i.e., transfer of information from electronic health records, data transfer from contractors to sponsors), and other data integrity issues under current regulations or determine if the existing regulations and guidance's need enhancements. This training and collaboration will help shape FDA and industry understanding of electronic data and information, and strengthen compliance and enforcement activities to support public health. Scope The contractor shall conduct the following tasks in accomplishing the objective of this contract. The contractor shall provide training on various methods for: Detecting fraud (Macros, proprietary software, other methods for analyzing data collected from regulated pharmaceuticals manufacturing firms), reviewing analytical data for potential electronic data fraud (e.g. data from spectrometry/chromatography), and methods of collecting data for forensic analysis, in relation to the Office of Information Management (OIM). Professional training, education, expertise, performance problems, and flaws in medical product and applications relevant to the specific needs of data-integrity and data auditing of computerized systems. Responses must include capability statements and duns number be sent to this notice no later than 10:00 a.m. EST on April 3, 2012 submitted by email to vida.niles@fda.hhs.gov,Vida Niles, Contract Specialist for consideration. Responses to this announcement will not be returned, nor will there be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and FDA may contact one or more respondents for clarifications and to enhance the Government's understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. NO TELEPHONE CALLS ACCEPTED.
