Meet FDA Regulatory Requirements

Meet FDA Regulatory Requirements

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WinSPC: FDA 21 CFR Part 11 compliant SPC Software


WinSPC supports the FDA 21 CFR Part 11 requirement for electronic signatures, making it easier for manufacturers to ensure compliance while improving their overall product and process quality. WinSPC meets FDA 21 CFR Part 11 requirements throughout the following functionality:

  • Complete audit trail documentation
  • Lot traceability
  • Electronic signatures
  • Electronic records
  • Advanced security controls and password protection
  • Easy reporting for nearly any event, including: times, electronic signatures, change histories, corrective actions, and more
  • Central data storage in a single SQL database (critical system data such as passwords and configurations plus application-specific data like audit trail documentation are examples of data stored centrally)

Professional services for FDA-regulated industries


Our Solution Delivery team offers the expertise, software validation, and documentation services you need to meet FDA regulatory requirements.

Full-service validation
Our experienced Solution Delivery team can conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validation tests and resolve any testing deviations to assure FDA 21 CFR 11 compliance.

Validation project kit
Companies may choose to perform their own validation using DataNet’s validation project kit. Our Validation kit includes detailed, pre-written IQ and OQ validation test templates. The toolkit is designed to help project team members complete the necessary validation requirements on their own, including application-specific templates covering specifications and PQ test protocols.

Validation support
To remain compliant, a company must make sure that system changes and upgrades remain in validation. DataNet offers on-demand resources to assist you in upgrading and maintaining compliance throughout your product life-cycle.

>>Next: Turnkey support




 
Visit us at Booth #727 for a demonstration of our latest WinSPC release.
 
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