WinSPC® Software from DataNet Satisfies 21 CFR Part 11 Requirement
DataNet Quality Systems provides the most robust real-time Statistical Process Control (SPC) software available to the medical device and pharmaceutical industry. WinSPC offers manufacturers a single solution for automated and manual data collection, real-time alarms, and advanced analytics that facilitate continuous improvement.
Award-winning WinSPC software has long been a trusted quality control solution chosen by manufacturers throughout the world. Renowned for its ease of use, WinSPC includes granular security and traceability capabilities, some of which are:
- Permission-based access to each functional area
- A built-in audit trail that maintains original product and process configurations, specifications, collection methods, and data values and that fully complies with the Electronic Records and Signatures requirement of FDA Title 21 CFR Part 11
- Configurable password controls that include: expiration dates, reuse prevention, masking, encryption, and the locking of a user account when the maximum number of incorrect password submissions is reached
- The automatic closing of the Data Collection window based on a configurable period of inactivity
- The ability to require users, when making certain changes, to supply a reason for making the change
These capabilities further enhance WinSPC’s reputation as the premier SPC solution for world-class medical device and pharmaceutical manufacturers.
Additional features that distinguish WinSPC include:
- Client/server architecture supporting deployments on Oracle and SQL Server databases
- Centralized administration that minimizes configuration time
- Direct data collection from almost any external source, such as gauges, serial devices, CMMs, PLCs, lab equipment, electronic testing equipment, and barcode readers
- Over 90 professionally formatted, ready-to-use reports that satisfy almost any information need imaginable
- Real-time alarms enabling immediate corrective action