Life Sciences

Real-time Statistical Process Control & Analysis for the Life Sciences Industry

Prevent Product Defects
Improve Product Release Cycles
Maximize Productivity and Profitability
Reduce Waste
Meet FDA Regulatory Requirements

DataNet Quality Systems provides Life Sciences manufacturers with a real-time Statistical Process Control (SPC) solution to automate, monitor, control, and improve product and process quality, resulting in better products, faster release cycles, and increased profitability.

Through a combination of real-time SPC software, implementation and configuration services, software validation, and a variety of extended support and service programs, DataNet offers a comprehensive solution designed to support your team throughout the entire quality control program lifecycle.

Real-time SPC software
IQ, OQ, PQ Validation Services
Web-based Manufacturing Intelligence

FDA 21 CFR 11 Compliance
Installation and Training Services
Extended Service and Support

Superior support for FDA-regulated industries

Ensure compliance with 21 CFR Part 11
WinSPC supports the FDA 21 CFR Part 11 requirement for electronic signatures, making it easier for manufacturers to ensure compliance while focusing on product and process quality. WinSPC offers the following functionality designed specifically to enable you to comply with FDA 21 CFR Part 11:

Complete audit trail documentation
Lot traceability
Electronic signatures
Electronic records
Advanced security controls and password protection
Event log: Store and retrieve nearly any type of system-wide activity, such as edits to data or specification limits, failed log-ins, and more
All system data and application data are stored centrally in a single SQL database (passwords, configurations, audit trail documentation, etc.)

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Log, store, search, trace & audit your process quality data using WinSPC's event log
WinSPC's system event log allows you to store virtually any vital process information, such as electronic signatures, corrective actions, systems edits and more. The enhanced filtering and search functions make it easy to produce reports for company audits and comply with regulatory requirements. Of course, all the event log data is stored in a central, secure database for compliance with FDA 21 CFR Part 11.

Search, store, sort, report, print, archive or export logged events
Capture audit trail documentation
Enable complete traceability
Capture electronic signatures
Perform fast queries

Software Validation

DataNet’s WinSPC Software Validation services allow you to quickly and cost-effectively validate your SPC software.

Installation Qualification
Operational Qualification
Performance Qualification
Validation Toolkits

Learn more about DataNet's Software Validation services

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Get Started

Download a free trial of WinSPC
Get a web demo of WinSPC and find out if it is right for you
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Customers & Industries

Free technical white papers to make choosing a quality solution for your organization easier.

Arkwright cuts product waste by 10-15%

“WinSPC resulted in improved process & product quality and productivity. This has been a critical step in the continuation of Arkwright's Six Sigma project management initiatives & the company's commitment to quality…”

Best-In-Class Manufacturers Trust DataNet Quality Control Software:

Abbott Laboratories
Becton Dickinson
Black & Decker
Con-Agra
Harley-Davidson
Hewlett Packard
Hitachi
Mannington
Minute Maid
Nestle-Purina
Panasonic
Pinnacle Foods Corp.
Sara Lee