Instrument Qualification
Network-distributed ACE (NDA) 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.
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Product Details
- 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.
- Key Literature
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Move Your Analytical Instrument Qualification to Agilent ACE
Compares Analytical Instrument Qualification using Agilent ACE with other options using Data Integrity and compliance with USP general chapter <1058> as a framework.
- Brochures
- English
- 14 Nov 2023
- 1.42 MB
Analytical Instrument Qualification
A comparison of qualification approaches across electronic, Excel, or paper-based protocols for HPLC.
- Technical Overviews
- English
- 15 Nov 2019
- 1.99 MB
Agilent CrossLab Network Distributed ACE (Alcoa+)
Agilent CrossLab Network Distributed ACE: How it Satisfies ALCOA + Data Integrity Requirements
- Flyers
- English
- 29 Jul 2022
- 212.28 KB
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Enterprise Edition provides the independently tested tools that ensure you never again need to review a handwritten report, use multiple protocols, or rely on nonproven in-house developed compliance programs that have not been evaluated.
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USP Analytical Instrument Qualification Compliance
Complying With the New USP General Chapter on Analytical Instrument Qualification
Compliance Consulting
Our CrossLab compliance consulting services are focused on critical areas such as computer system validation (CSV) for GAMP5 (risk-based approach and V model) and part/annex 11 (electronic records and signatures), audits/assessments for data integrity, and custom procedure writing. An example of custom procedures writing is helping laboratories comply with the 2017 USP <1058> for AIQ.|Agilent has developed validation starter kits, a comprehensive suite of generic validation documents that will accelerate the process to save both time and money. Harness Agilent CrossLab global compliance expertise to enable your lab to focus on your science and increase core productivity.