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Confidently Navigate Electronic Records Compliance with waters_connect for Quantitation

Meeting data integrity expectations, including 21 CFR Part 11 compliance, continues to be a significant challenge for laboratories. As regulatory requirements evolve, the shift from paper-based records to more efficient and complete electronic records is becoming essential – not just for compliance, but for improving overall laboratory productivity and data reliability.

Simply implementing an informatics platform that incorporates Part 11 or Annex 11 technical controls does not automatically ensure compliance or guarantee data integrity. However, selecting a system with technical controls is a critical foundation for any laboratory operating in a regulated environment.

waters_connect for Quantitation is designed to support laboratories in this process, helping to ensure compliance and reduce administrative burden through key capabilities and features like:

  • Restricted system access to protect data
  • A fully automated audit trail for complete traceability
  • Secure electronic signatures to verify records

Download the white paper for a detailed overview of how waters_connect for Quantitation integrates technical controls that support 21 CFR 21 and Annex 11 compliance, so labs like yours can confidently meet global electronic record regulations.