Many manufacturers–especially those in the Food & Beverage, Pharmaceutical, and Life Sciences industry–are subject to strict regulatory requirements surrounding electronic record keeping, product traceability, and security. Additionally, many manufacturers in the transportation and consumer goods industries must maintain ISO certification to satisfy customers and win new business. WinSPC offers a variety of features that enhance and support a company’s ability to cost-effectively comply with ISO, TS, FDA and USDA regulatory requirements.
Support FDA 21 CFR part 11 requirements for electronic signatures and forced log-outs for system security The FDA 21 CFR Part 11 regulation 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 user-defined groups.
Securely store and centralize all electronic records WinSPC securely stores all data in a centralized application database to comply with data security requirements, electronic signatures, and audit traceability requirements.
Record every system event WinSPC’s event log maintains a record of every system event, including specification limit changes, deletion of event log items, electronic signatures, and system configuration changes. This lowers documentation costs and ensures 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’s event log filter allows users to quickly retrieve nearly all system activities such as startup/shutdown, security, administration, data collection, and violations.