General Principles of Software Validation; Final Guidance for Industry and FDA Staff
Maynard, MA (PRWEB) October 5, 2007
QuadTech, a leading provider of electrical safety test and passive component measurement solutions, today released CaptivATE 3.2, the latest version of its electrical safety testing automation software. A key feature in the updated software is the ability to output test data to a csv file for easy import from CaptivATE into any enterprise system, such as a Manufacturing Execution System (MES).
QuadTech understands that thorough and accurate documentation is essential in the manufacturing of medical devices. QuadTech VP Technical Operations, Robert M. Brown says, "CaptivATE 3.2 has been developed in strict accordance with QuadTech's documented Software Development Lifecycle (SDLC) process to build-in quality. As an ISO certified company, QuadTech's SDLC process relates to the overall QuadTech Quality System, ensuring quality controlled software."
QuadTech's SDLC also supports medical device manufacturers validation requirements for off-the-shelf (OTS) software, as defined in the "General Principles of Software Validation; Final Guidance for Industry and FDA Staff", Version 2.0, dated January 11, 2002.
Additionally, the FDA's Quality System regulation, 21 CFR PART 820, requires that "when computers or automated data processing systems are used as part of production or the quality system the [device] manufacturer shall validate computer software for its intended use according to an established protocol." This has been an FDA regulatory requirement since 1978 - part of the FDA's medical device "Good Manufacturing Practice" (GMP). QuadTech makes meeting this requirement easy by providing an Installation Qualification and Operational Qualification (IQOQ) protocol, which enables customers to quickly, easily and confidently verify the installation and operational parameters are performing as specified.
The following QuadTech products are supported by CaptivATE 3.2: All Sentinel Systems, Guardian 6100 Plus Electrical Safety Analyzer, Guardian 6100 Electrical Safety Analyzer, Guardian 6000 Plus Electrical Safety Analyzer, Guardian 6000 Electrical Safety Tester, Guardian 1000 Multi-Purpose AC/DC/IR/SC Series Hipot Testers (CE Mark), and the Hybrid 2000 AC/DC/IR/DCR Analyzer.
The operational enhancements and user interface improvements in CaptivATE 3.2 were incorporated in an effort to continue better serving QuadTech customers. For more information, please visit http://www.quadtech.com.
QuadTech, an ISO 9001-Registered company, is a solutions provider enabling Medical Device Manufacturers and other manufacturers requiring electrical safety test measurement solutions to test the safety and quality of their electrical products while ensuring compliance to FDA and other regulatory agencies. QuadTech offers a complete line of instrumentation and solutions including LCR meters, hipot and ground bond testers, safety analyzers, megohmmeters, milliohmmeters, systems and software, as well as calibration and repair services. Based in Maynard, MA, QuadTech has a worldwide network of direct sales and distributors who service and support customers around the globe. QuadTech is dedicated to doing everything in its power to assist the customer in achieving their testing objectives.