Instrument Qualification & Verification Services
Simplify your data integrity
- Agilent’s compliance solutions have been helping labs evolve and stay audit-ready with global standards for over 20 years. Automated qualification, metrology-based verification, and ACE software simplify workflows, reduce regulatory risk, and uphold ALCOA+ data integrity. Whether you're preparing for inspections or streamlining documentation, trust the #1 compliance provider to deliver expert, efficient services to keep your lab focused on the science.
- Automated qualification services: Streamlined compliance with paperless protocols that save time and reduce human error
- Metrology-based verification: Delivers precision testing aligned with ISO 17025 standards to validate instrument performance and accuracy
- Audit-ready ACE software: Our Automated Compliance Engine (ACE) software ensures data integrity to execute, document, and store every test
- Harmonized protocols: Standardize qualification across vendors and instruments for consistent, lab-wide compliance
- Configurable test programs: Adapts to SOPs, allowing labs to select specifications that match their internal compliance requirements
- Global standards alignment: Reduces regulatory risk by meeting USP <1058>, ISO 17025, and ALCOA+ data integrity expectations
Instrument Qualification & Verification Services
Simplify your data integrity
Compliance & Validation Services
Features
How it works
Ensure accuracy and reliability of your instruments with Agilent's Qualification and Verification services
Instrument qualification for regulatory
Regulated laboratories must demonstrate their analytical instruments are fit for use, and AIQ is the most effective way to do so. Properly executed AIQ reduces audit risk, protects data integrity, and ensures that results remain valid by confirming instruments perform as expected.
Agilent's Qualification service are designed to help support qualification needs at all necessary points in the instrument lifecycle, such as:
- Installation and Relocation: Ensures the instrument is set up correctly and ready for operation
- Scheduled Requalification: Operational Qualification (OQ) is typically required annually (or at a frequency defined by regulatory or internal policy) to confirm the instrument continues to meet operational specifications over time
- After Repairs: Repair Qualification (RQ) is triggered after any significant repair. RQ verifies the instrument is restored to a qualified state.
Streamlined, paperless qualification with ACE
How your instruments are qualified is just as important as the qualification itself. That's why we developed ACE: Automated Compliance Engine software to deliver consistent and streamlined qualification and verification services.
Unlike any compliance software in the market, ACE helps you implement a cost-effective qualification process to align with your SOPs and comply with the 2017 USP <1058> requirements.
Complete traceability is synonymous with data integrity and is key to reducing time spent reviewing and approving. Agilent compliance-certified engineers use automated protocols and testing equipment to quickly deliver your qualification report and certificate, so you can return to production faster. With plans and reports stored electronically, your documents are easy to find and minimize any risk of noncompliance.
Reduce cost and risk with Agilent Compliance
To address terminology inconsistencies in global regulatory quality guidance, Agilent has created this table to define and differentiate some common compliance terms for services that Agilent offers, so you can understand what's required for your lab and start working towards those objectives.
How you address laboratory compliance is dependent on the regulatory guidelines you are adhering to, industry you operate in, and customers you serve. Agilent's diverse compliance offerings help streamline what is required for your lab, allowing you to demonstrate compliance in a timely manner. This provides you the tools to meet important deadlines and exceed customer expectations with end-to-end traceability.
From qualification to validation: what level of compliance support do you need?
Compare Agilent’s Qualification & Verification services with Compliance Consulting and Validation to understand differences in scope, support, and use cases. Select the right solution for your regulatory requirements and data integrity goals.
Laboratory Compliance Risk Assessment Guide
Balancing essential standards of compliance with appropriate cost effectiveness is challenging to get right. To help laboratories understand potential laboratory compliance risks, Agilent has developed a risk assessment guide.
Compliance Consulting Products & Services
Streamline validation and improve audit readiness with Validation Starter Kits and Compliance Consulting services
Stories from the lab of efficiency and data integrity
"Compliance is never ending challenge. As an FSE, using ACE simplifies those challenges as the software automatically prompts for documentation or correction and provides clear directions for the required testing. This significantly reduces operator variability or error and allows me to focus more on the work and the customer rather than the paperwork."
~ Agilent Certified Professional
Documents & support: learn, troubleshoot & train
Explore educational videos, training modules, product support, and interactive tools—all in one place
Move Your Analytical Instrument Qualification to Agilent ACE
Brochure that compares Analytical Instrument Qualification using Agilent ACE with other options using Data Integrity and compliance with USP general chapter <1058> as a framework.
Brochure
Advantages and Management of Agilent Digital Qualification Templates
Brochure about Agilent's electronic approach of using EQPs and EQRs through the ACE software has a number of significant advantages over other options.
Brochure
Digital Equipment Qualification Plan (EQP) Management
Flyer about how Agilent has released EQP Manager to simplify electronic review and approval of EQPs.
Flyer
How to Comply with the 2017 Version of USP <1058> 5991-9419
This white paper provides laboratories with deeper insights into the significance of the changes implemented in the 2017 USP <1058> and practical information about how to comply with these changes.
White Paper
Preferences and Trends in Qualification Practices in Regulated Labs
In both qualification and computer software validation service categories, Agilent CrossLab Compliance Services is clearly selected as the first-choice leader and most-trusted compliance service provider.
Flyer
Agilent Compliance Services Differentiation
This flyer clarifies and differentiates Agilent compliance services verification, qualification, and computer system validation so laboratories can understand regulatory expectations and choose the right services for their needs.
Flyer
Frequently asked questions
Can Agilent help me assess my laboratory's compliance risk?
Use the Agilent Risk Guide to determine your level of compliance risk and what remediation actions to take.
What are the differences between Qualification, Verification, and Computer System Validation services?
Terms associated with laboratory compliance can have multiple meanings; what a term means at one company may differ from another. Learn how Agilent defines and differentiates common compliance terms.
Why is AIQ important?
Regulated laboratories must demonstrate that the analytical instruments they use are suitable for their intended use, and performing AIQ is the best way to do this. A well implemented AIQ process reduces potential audit risks associated with laboratory instruments and safeguards the data they generate.
Why do I need RQ (Repair Qualification) and what is the benefit of Agilent RQ program?
USP <1058> states that when a qualified instrument is repaired, it needs to be re-qualified before it is used: “The relevant OQ or PQ test(s) should be repeated after the maintenance or repair to ensure that the instrument remains qualified”. To support laboratories with different requirements, Agilent provides several RQ test plans.
Does Agilent guarantee a qualification pass?
When paired with a CrossLab Silver plan, Agilent guarantees a passing qualification for your system.
Is ACE (Automated Compliance Engine) validated and 21 CFR Part 11 compliant?
ACE is designed to integrate with 21 CFR Part 11 compliant processes and environments. For further information on how ACE achieves this, contact your local Agilent representative.
I had an IQ/OQ performed on my newly installed instrument. How frequently should my equipment be requalified?
Most customers choose to have OQs performed annually, although the FDA recommends you justify your re-qualificaiton schedule by considering frequency of use and compliance risk. In addition, the FDA recommends that systems are requalified after being repaired or relocated.
What instruments / manufacturers can Agilent support with compliance services?
Agilent can support compliance on most major makes and models of laboratory instrumentation.
To find out if Agilent can support the systems in your lab, contact your local Agilent representative.
Why does Agilent use ACE and not a CDS based workflow?
Agilent believes that using independent calculations outside of the CDS leads to a more objective, and therefore, more compliant qualification. In addition, this agnostic approach is paramount to the broad reach Agilent's multi-vendor capabilities.
Where can I find Agilent's qualification test suite?
Agilent's standard EQPs can be downloaded from EQP Manager. The standard EQPs contain the Agilent recommended tests, setpoints, and tolerances.
Can Agilent configure their qualification protocols to our URS?
Yes. ACE protocols are customizable, meaning that optional and extra tests can be added. And within those tests, setpoints and tolerances can be altered. Contact your local Agilent representative who can put you in touch with an EQP Admin to help you make the EQP customizations you need to align with your URS or SOP.
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Remote-enabled support that reduces trips, speeds fixes, and lowers environmental impact
- Agilent delivers high-performance services with sustainability in mind by reducing travel and leveraging remote support when possible
- Secure video, chat, and image annotation tools enable fast, accurate issue resolution with Agilent Virtual Tech Support
- Remote diagnostics help engineers arrive with the right parts, increasing first-time fix rates and reducing repeat visits
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The result: Fewer service trips, a lower carbon footprint, faster resolutions, and improved total cost of ownership.
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Consumables for repair
Typical consumables that may be included at no charge if they are needed to execute a repair under a covered plan.
Service advisor tool
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