January 4, 2022
Get Faster and More Cost Effective WinSPC Validation with the IQ and OQ Toolkit
In its continuous effort to improve its software products and services, DataNet updated its software validation toolkit and services to enable DataNet customers to significantly reduce the time and costs associated with validating WinSPC Version 9.0 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 9.0. It contains about 30 test scripts that cover the basic functionality of WinSPC installation and software operation. 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 also 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, such as Life Sciences, a path from purchase-through-validation. Not only does WinSPC facilitate increasing a company’s overall productivity, but its validation toolkit and the related professional services significantly reduce the total cost of ownership.
For more information about DataNet’s software, validation services, and software validation toolkit, call (866) 4WINSPC.