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How to Comply with the 2017 Version of USP <1058>

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Agilent offers a comprehensive set of compliance services, including instrument and software qualifications (IQOQ, OQ, and RQ) based on USP <1058> analytical instrument qualification (AIQ), and is a foundation for data integrity. We provide an automated, electronic compliance solution designed to support the end-to-end USP <1058> AIQ process.

Network-distributed ACE 3 platform provides tighter integration with data sources and simplified workflow documentation. The fully harmonized instrument qualification approach includes consistency across instruments, configurable testing to match your standard operating procedures, end-to-end traceability, electronic reports and signatures, and the ability to maintain critical data within your organization’s network

Features:

  • Minimize your regulatory audit risk—Agilent can help you implement a cost-effective qualification process to align with your SOPs and comply with the 2017 USP <1058> requirements.
  • Standardize your program—Agilent CrossLab automated compliance engine (ACE) software assures adherence to protocol, accurate results, consistent calculations, and paperless reports that are easily stored, searched, and retrieved.
  • Reduce time and costs—a truly cost-effective qualification service that reduces review and approval time. Qualification plans and reports are available electronically to ensure data integrity and easy storage, as well as search and retrieval.
  • Improve efficiency—Agilent compliance-certified engineers use proven automated protocols and testing equipment to quickly and reliably deliver your qualification report and certificate to get your systems back into production faster.
  • Simplify your documentation workflow—your Agilent CrossLab Installation qualification (IQ) and operational qualification (OQ) reports provide audit-ready documentation with complete traceability to minimize your risk of noncompliance.
  • Adaptable to your SOP—configurable test programs allow you to select specifications that enable testing over the operational range of your instrument according to the requirements of your specific SOP.

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