Comply with Regulatory Requirements

Securely build product and process audit-ability into the manufacturing process

Benefits

• Meet regulatory and customer requirements
• Reduce risk
• Increase customer satisfaction
• Lower the cost of compliance
• Improve the ability to sustain regulatory compliance
• Simplify the compliance process
• Fulfill ISO, TS, QS requirements
• Comply with FDA 21 CFR Part 11

Features

Support FDA 21 CFR part 11 requirements for electronic signatures and forced log-outs for system security The FDA 21 CFR Part 11 regulation published by the FDA was designed to enforce the integrity and security of records that are stored electronically within industries governed by the FDA. WinSPC supports the electronic signatures, data security and audit traceability requirements of the FDA. Additionally, WinSPC supports advanced security policies and allows system administrators to: easily manage and organize a large volume of system users, manage system-wide security policies, and assign role-based privileges to managers, administrators, shop-floor operators and other “defined” groups.
Securely store and centralize all electronic records Enable WinSPC’s optional event log feature to capture and trace any system event that takes place within WinSPC. This enables your company to lower documentation costs by capturing and storing this data electronically. WinSPC’s securely stores all data in the application database to comply with data security requirements, electronic signatures, and audit traceability requirements of the FDA.
Record every system event WinSPC’s event log maintains a record of every system event, including the deletion of event log items, electronic signatures, and system configuration changes. This assures that your organization, if required, can trace any and all process events that take place within WinSPC.
Search, sort, filter and report on almost anything WinSPC event log filter allows users to quickly retrieve nearly all system activities such as startup/shutdown, security, administration, data collection and violations.
Maintain an audit trail Using WinSPC to cost-effectively maintain an electronic audit trail. By capturing the right information within WinSPC, quality managers can quickly and easily produce the necessary information to withstand an ISO audit.
Log all changes to customer specifications Use WinSPC’s event log to capture and record any changes to customer specification. For instance, if a specification limit was changed within WinSPC, a system administrator can search the event log to determine when the change was made and by whom.
Quickly and cost-effectively perform software validation Cost-effectively validate WinSPC software using DataNet’s Validation Toolkit. It contains a complete set of test procedures and documentation templates required to meet the software validation requirements of the FDA. Alternatively, DataNet’s solution delivery professionals offer turn-key software validation services that include Installation Qualification, Operational Qualification and Performance Qualification of your WinSPC software solution. Get more information on DataNet Software Validation services.
Support compliance requirements/activities for ISO, QS, TS FDA, and USDA  WinSPC meets the SPC requirements of ISO certification and enables your company to quickly and cost-effectively measure, analyze, monitor and report quality procedures within your organization to effectively meet and/or assure compliance with ISO, QS, TS, FDA, and USDA.