Achieve Regulatory Compliance

Achieve Regulatory Compliance

Securely build product and process auditability into the manufacturing process

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.

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, FDA & USDA requirements
  • Comply with the electronic signatures requirements of 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 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.

Maintain an audit trail
Use 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 pass an ISO audit.
Quickly and cost-effectively perform software validation
Cost-effectively validate WinSPC software using DataNet’s Validation Toolkit. The Toolkit 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, TS FDA, and USDA
WinSPC meets the SPC requirements of certification protocols 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, TS, FDA, and USDA.