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: