SAM #75F40126Q00330

FDA Procurement of Agilent OpenLab CDS and ECM Software Suite with Maintenance and Installation

The U.S. Food and Drug Administration (FDA) Office of Pharmaceutical Quality Research (OPQR) is seeking to procure and maintain Agilent OpenLab CDS and ECM software for laboratory operations in Saint Louis and Silver Spring. - Government Buyer: - U.S. Food and Drug Administration (FDA) - Center for Drug Evaluation and Research (CDER) - Office of Pharmaceutical Quality Research (OPQR) - OEM Highlight: - Agilent is the specified Original Equipment Manufacturer (OEM) for all software and related modules - Vendors Mentioned: - Agilent (OEM) - Products and Quantities Requested: - Open Lab ECM Enterprise Server Software (G3651AA): 3 units - Open Lab ECM Named User (G3657AA): 87 licenses - Open Lab ECM Instrument Connection (G6731AA): 42 connections - Open Lab Business Process Manager (G3653AA): 1 unit - GCMS Mass Hunter Software (G1701FA): 1 unit - LCMS QQQ Mass Hunter Software (G3337AA): 2 units - GCMS QQQ Mass Hunter Software (G6849AA): 2 units - Mass Hunter Access Control (G3339AA): 7 units - Mass Hunter TOF/QTOF Software (G3849AA): 3 units - Open Lab CDS Shared Services (M8305AA): 4 units - Open Lab Chem Station AIC (M8303AA): 14 units - Agilent LC Driver (M8510AA, M8500AA): 21 units (various part numbers) - Agilent 3D UV Driver (M8360AA): 11 units - Agilent GC Driver (M8400AA): 1 unit - Open Lab Chem Station Workstation (M8301AA): 4 units - Open Lab CDS Waters Acquity Driver (M8505BA): 2 units - Pro-rated Software Maintenance Agreement for OpenLab Chemstation (R3881A): 8 units - Core OpenLab ECM Classic Backend Migration (R4700RM): 3 units - Core OpenLab ECM Classic, IQ/OQ (R4700RQ): 3 units - OpenLab Shared Service, IQ/OQ (R4678RQ): 3 units - Open LAB CDS AIC Qualification (IQ/OQ) (R2329A): 16 units - Mass Hunter Software for GCMS QQQ (G1739FA): 2 units - G5330AA: 1 unit - Open Lab CDS Workstation (M8413AA): 7 units - OpenLab CDS Connection/Instrument Connection (M8431AA): 31 units - OpenLab CDS AIC (M8420AA): 3 units - CDS AIC Inst IQ/OQ (R4660RD): 3 units - CDS Client Inst IQ/OQ (R4662RD): 4 units - Notable Requirements: - All software and modules must be Agilent brand name - Includes installation, maintenance, and qualification (IQ/OQ) services - Compliance with Section 508 accessibility standards is required - Firm-fixed price contract structure - Purpose: - Supports laboratory research, regulatory activities, and data management for pharmaceutical quality research

Description

The Office of Pharmaceutical Quality Research (OPQR) is a CDER laboratory-based office that utilizes broad range of analytical methods and computer modeling to conduct research to evaluate the product and process design their impact on product quality. 

The Agilent OpenLab CDS (Chromatography Data System) and ECM (Enterprise Content Management) system currently in use at the Office of Pharmaceutical Quality Research (OPQR) needs a service contract to ensure that software is updated, and all reported problems are properly addressed. Agilent OpenLab CDS and ECM system is used on a daily basis in conjunction with various research and regulatory studies performed at OPQR.  It is the principal software used to control HPLC systems and to analyze and save chromatographic data.  Therefore, it is critical to the Office’s mission.

View original listing