Instrument Qualification Services

Instrument Qualification Services

Maximize compliance confidence while ensuring the integrity and accuracy of your results using Waters Instrument Qualification and Compliance Services.

Maximize compliance confidence while ensuring the integrity and accuracy of your results using Waters Instrument Qualification and Compliance Services.
Researcher or scientist running experiment at Immerse Lab

Navigating through analytical instrument system qualification and validation and staying on top of documentation requirements from regulators can be challenging and time-consuming.

Waters Instrument Qualification and Compliance Services team has helped labs meet their business and compliance needs effectively and efficiently for more than five decades. With more than 500,000 successful engagements, Waters experts are respected within regulated industries worldwide.

Our dedicated team ensures that your workstation, workgroup, or enterprise solution is fit for its intended use and meets your regulatory requirements.

Empower-Based System Services
Accurately determine overall system-level performance with audit-ready qualification data directly from your database from Waters Empower-Based System Services and the Empower SystemsQT Qualification Tool (SQT).

MassLynx-Based System Services
Meet MS and LC-MS compliance requirements for your laboratory using Waters MassLynx-Based System Services, which fully support GxP and 21 CFR Part 11 regulations.

waters_connect-Based System Services
Deliver connected science with compliance using waters_connect-Based System Services, and benefit from built-in data integrity controls that align with applicable regulatory guidelines.

Services for Agilent HPLC, UHPLC and GC Systems
Explore our compliance, maintenance, and repair services for Agilent HPLC, UHPLC, and GC systems controlled by Empower Software.

Professional Services
Meet lab software compliance requirements, qualify and validate lab instruments, keep current with regulations and produce quality LC-MS data using Waters Professional Services.

Analytical and Laboratory Services
Accelerate software adoption and improve laboratory effectiveness with Waters consultative services, software applications and analytical business tools.
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Instrument Qualification Services: Ensuring Accuracy and Compliance

Instrument Qualification Services help laboratories verify that their equipment is correctly installed, functioning as expected, and delivering reliable results. These services are essential in industries such as pharmaceuticals, biotechnology, food safety, and environmental testing, where accuracy and compliance with regulations like FDA, ISO, USP, and GMP are crucial.

The qualification process consists of three key stages:

Installation Qualification (IQ) Confirms that the instrument is installed correctly, in the right environment, and meets the manufacturer"s requirements. This includes checking documentation, verifying power supply, and ensuring proper setup to prevent errors.

Operational Qualification (OQ) Tests whether the instrument operates according to the manufacturer"s specifications. This involves running tests to assess accuracy, precision, and performance under controlled conditions, ensuring reliability in routine operations.

Performance Qualification (PQ) Evaluates how well the instrument performs with actual laboratory samples. Unlike OQ, this step tests real-world applications to confirm consistency, accuracy, and long-term reliability, especially in regulated industries.

A structured qualification process provides several benefits, including regulatory compliance, improved data accuracy, reduced equipment downtime, and easier audit preparation. By ensuring instruments function correctly, laboratories can minimize risks, avoid costly errors, and maintain high-quality results.

Waters Instrument Qualification Services offer expert support to help laboratories qualify a wide range of equipment, including HPLC, UPLC, and mass spectrometry systems. Their tailored solutions ensure compliance with industry standards, optimize instrument performance, and reduce operational risks.

For laboratories aiming to enhance compliance and accuracy, investing in a structured Instrument Qualification strategy is essential. Whether for new installations or ongoing validation, these services provide confidence in data integrity and regulatory readiness.