Controlling pharmaceutical manufacturing operations would be much more difficult without software. Information-technology
(IT) solutions can store information and make it available to relevant personnel in laboratories, production lines, and at
the enterprise level. The technology thus facilitates quick and informed decisions and provides early alerts about failures.
This month's IT products buttress pharmaceutical operations in various ways. AspenTech's application aids batch-process development
by facilitating the sharing of information. Sparta Systems's quality-management software ensures that data are accurate by
linking to appropriate sources. Master Control's software lets users download documents to familiar applications.
Software performs solubility and reaction modeling
AspenTech (Burlington, MA) has introduced version 7 of its aspenONE software, which is designed to enhance batch-process development
by creating a framework where recipes can be created, refined, and passed from the research to the pilot and manufacturing
stages. Based on four or five solubility measurements of a new chemical entity (NCE), the software generates thermodynamic
constants and estimates the NCE's solubility in untested solvents.
aspenONE software AspenTech www.aspentech.com
Users also can enter reaction data that the software matches with a thermodynamic model to simulate how a reaction will work
under untested conditions. These capabilities can eliminate as much as 80% of a company's experimentation in solvent selection
and route selection, according to Jamie Hintlian, AspenTech's vice-president of pharmaceuticals. The new aspenONE software
generates recipes consistent with ISA-88 based on user input, and draws from a database of chemical properties for thousands
Quality-management software offers web services
The TrackWise enterprise quality-management solution from Sparta Systems (Holmdel, NJ) now includes web services that allow
the software to integrate with common enterprise resource planning (ERP) systems. Through web services, the software can validate
master data by comparing them to the appropriate sources in real time. TrackWise allows third-party systems to access its
key functions (e.g., the automated creation of quality events) and gain a consolidated view of quality information. The software
reduces manual steps that are potential sources of error.
TrackWise software Sparta Systems www.sparta-systems.com
Quality-management suite offers enhanced training features
Master Control (Salt Lake City, UT) has introduced version 8.0 of its quality-management suite (QMS), which is designed to
meet the needs of quality, regulatory, submission-publishing, and manufacturing groups. The software's robust training module
now allows users to schedule classes in addition to assigning classrooms and instructors, says Lane Hirning, the company's
senior product manager. The QMS triggers training when tightly controlled documents such as work instructions are modified.
Master Control software Master Control www.mastercontrol.com
The new version of the product integrates with common applications, thus enabling users to work with familiar software. For
example, personnel can download documents from the QMS directly into Microsoft's Word program. Users also can receive and
sign off on tasks using Microsoft's Outlook application.
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