July 21, 2008
DataNet Makes it Faster and More Cost Effective to Validate WinSPC with its Enhanced Software IQ and OQ Toolkit
In its continuous effort to provide superior Statistical Process Control software products and services, DataNet recently updated and enhanced its software validation toolkit and services that will enable DataNet customers to significantly reduce time and costs associated with validating WinSPC Version 7.2 as part of the FDA’s 21 CFR Part 11 requirement.
FDA’s 21 CFR Part 11 requires companies to validate that their installed electronic record-keeping systems perform accurately, reliably and consistently and have the ability to detect invalid or altered records. DataNet’s Valitation Toolkit assists companies in validating WinSPC and the electronic record-keeping component of the FDA 21 CFR 11 requirement.
For virtually all Life Sciences companies, the process of validating software systems is complex and costly. DataNet has been one of the few Statistical Process Control software providers in the industry to offer expert software validation services and do-it-yourself validation toolkits.
DataNet’s Solution Delivery team offers years of experience in assisting Life Sciences customers with Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) of software systems.
For companies preferring to validate WinSPC on their own, DataNet’s validation toolkit includes detailed, pre-written IQ and OQ validation protocols specifically for validating WinSPC within a federally regulated environment.
The latest validation toolkit is a protocol for IQ and OQ of WinSPC 7.2. It contains about 29 test scripts that test the basic functionality of WinSPC covering installation and operation of the software. The protocol has been formatted and designed with detailed steps for executing the tests and documenting the results/actions required. The expected results are explained with screen shots.
DataNet’s Solution Delivery professionals use the toolkit as part of the validation services provided to FDA-regulated customers. In addition to the IQ and OQ services, DataNet provides PQ validation services focusing on how WinSPC is used in a live, production environment.
To ensure that the protocol includes all the features from the latest version of WinSPC, DataNet regularly updates the IQ and OQ protocols and can readily create/modify the PQ protocol. Now, with the ready-made IQ/OQ protocols and quickly created PQ protocol, DataNet customers can validate much faster when they choose to upgrade to the latest version of WinSPC in production.
DataNet offers regulated industries, like the Life Sciences industry, a “purchase through validation” advantage. Not only does owning WinSPC increase a company’s overall productivity, but the validation toolkit and services significantly reduce the Total Cost of Ownership. For more information about DataNet’s software, validation services, and software validation toolkit, call (866) 4WINSPC.