CrossLab Compliance

Data integrity is a significant driver in the compliance industry with which we must all comply. As the regulatory environment becomes more stringent, regulated labs must be prepared to prove that their data have not been compromised.

In response to this continued regulatory focus, Agilent offers an automated, electronic compliance solution designed to support the end-to-end Analytical Instrument Qualification (AIQ) process. To further fulfill data integrity and traceability requirements, we have recently upgraded our audit-ready, paperless instrument qualification software. Network Distributed ACE provides tighter integration with data sources and simpler workflow documentation. Its capabilities offer a fully harmonized instrument qualification approach, including 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.

Leveraging our configurable, vendor-neutral, and CDS agnostic platform, customers can feel confident in compliance to regulations.

Features:

• Minimize your regulatory audit risk - Agilent can help you implement cost-effective qualification process to align with your SOPs to 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.