Meaningful results are the heartbeat of any laboratory. When results must be reliable, every piece of equipment must perform flawlessly. However, ensuring accuracy and precision is not just about routine upkeep; it is about understanding the key processes that keep your equipment performing at its best.
Equipment inaccuracy costs labs billions annually in wasted materials and failed audits. Some of these inaccuracies are due to a misunderstanding of important terminology.
Many people confuse or overlook the terms qualification, calibration, verification, validation, and system suitability testing (SST).
These terms may seem interchangeable, but each serves a distinct role. Skipping or misapplying them can cause:
Accuracy refers to the degree to which a measurement aligns with the true value or target, while precision denotes the consistency of measurements, regardless of their proximity to the target. For instance, in measuring a product's weight, achieving accuracy means to obtain the exact weight, whereas precision indicates that repeated measurements yield similar results, even if those results deviate from the true value.
We use clear definitions at METTLER TOLEDO to ensure consistency across industries, regions, and applications. Knowing these distinctions helps you make informed decisions and maintain high standards, whether installing new equipment or conducting routine checks.
Each process plays a vital role in maintaining accurate, precise, compliant, and efficient lab operations and helps to answer the following:
Is the instrument correctly installed and ready for its intended use?
Does the instrument’s measurement align with a certified reference standard?
Does the instrument consistently perform within predefined tolerances?
Does the entire analytical system perform correctly?
Does the computerized system work as intended? Does it meet user expectations (requirements) and specific regulations?
Ignoring one or more of these steps can lead to inaccurate and imprecise results and operational setbacks, especially in industries where reliable results are crucial. These services are essential for maintaining the integrity of your lab’s vital equipment, including:
Before any lab equipment can be trusted for accurate and precise results, it must be adequately qualified.
Instrument Qualification verifies that an instrument is installed correctly, operates as expected, and meets regulatory and operational standards. This process provides confidence in the instrument's performance from the beginning.
While equipment owners are responsible for qualification, the complexity of modern instruments often leads labs to rely on manufacturers ' expertise. METTLER TOLEDO provides comprehensive qualification services to streamline this process and eliminate uncertainty.
METTLER TOLEDO also recommends that you perform an initial calibration after qualification. This action helps to ensure the instrument's accuracy in its environment and confirms that the equipment operates within specified tolerances and is ready for optimal performance.
Instrument Qualification Consists of Three Key Steps:
Ensuring Proper Setup
IQ answers the question: Is the instrument installed correctly and ready for use?
This step verifies that the instrument is delivered as expected, installed according to predefined specifications, and placed in a suitable environment for safe and effective usage.
IQ is typically performed when:
A METTLER TOLEDO Service Technician assesses all components, verifies installation, and ensures that environmental conditions support proper operation. Detailed documentation is provided, which may be required for regulatory compliance.
Confirming Functional Accuracy
OQ answers the question: Does the instrument perform correctly?
Once the IQ is completed, the OQ verifies that all hardware and software functions operate correctly under controlled test conditions.
During OQ, a METTLER TOLEDO Service Technician runs a series of operational tests to confirm that:
This qualification step ensures that the equipment works correctly before being used actively.
Ensuring Consistent Output
PQ answers the question: What procedures and tests should be performed to ensure correct and continued performance during routine operation?
This step verifies that the instrument delivers reproducible results when used as intended in the lab’s daily operations.
PQ is an ongoing process for checking equipment's consistent and accurate performance throughout its life cycle. This ensures:
Depending on the industry regulations, you might need to provide more details for some or all of these qualification steps.
Calibration is the process of comparing measurement values delivered by a device to those of a reference standard with known accuracy. This is an essential step for any laboratory that uses measuring equipment, such as balances, scales, moisture analyzers, or thermal analysis instruments. Calibration is crucial for ensuring that laboratory instruments provide accurate, precise, and consistent measurements. It involves checking an instrument's reading against a known certified reference standard.
This process helps identify any differences and prevents errors that could impact research, production, or compliance. By spotting and correcting these differences early, laboratories can maintain their precision and meet regulatory standards.
Calibration involves testing an instrument at multiple measurement points across its operational range. A METTLER TOLEDO Service Technician carefully evaluates deviations to ensure the instrument operates within acceptable tolerances. These deviations can result from:
Calibration schedules are determined through risk assessment, considering factors like instrument criticality, usage frequency, and regulatory requirements. High-risk instruments or instruments used in critical processes often require more frequent calibration to maintain measurement integrity.
Calibration steps include:
Regular calibration is vital for quality control. It ensures ongoing measurement accuracy and compliance with the International Organization for Standardization (ISO), Good Manufacturing Practices (GMP), and various Pharmacopoeia standards. By proactively calibrating instruments, labs avoid costly errors, regulatory violations, and unreliable data.
If deviations exceed acceptable tolerances, adjustments may be necessary to bring the instrument back into compliance.
As stated, calibration checks how accurate and precise an instrument is by comparing its measurements to a known reference.
If significant deviations are found during Calibration, adjustments are made to restore accuracy and ensure that the instrument meets acceptable limits. These adjustments are only performed when deviations exceed established tolerances, and must be carefully executed to:
Adjustments following a failed calibration help restore accurate, repeatable results, safeguarding data integrity and regulatory compliance.
Laboratory instruments need to work well at installation and continue delivering precise results throughout their life cycles. Performance Verification continuously checks that an instrument remains compliant with predefined requirements and consistently produces accurate data.
Why Regular Performance Checks Are Important
Over time, frequent use, environmental conditions, and aging components can cause instruments to drift from their original specifications. Verification catches these deviations early, helping to prevent:
Usually, the schedule and method of performance verification are defined during the initial Performance Qualification (PQ). This means that both the frequency of verification and the testing approach are determined at the outset, ensuring long-term consistency in monitoring instrument performance. Laboratory personnel and METTLER TOLEDO Service technicians perform these assessments. They follow strict industry and regulatory guidelines.
Regular performance verification helps labs avoid costly errors while ensuring continuous performance and compliance. By proactively verifying instrument performance, labs maintain confidence in their data and prevent unnecessary downtime.
In analytical laboratories, accuracy is not just about the instrument - it is about how the entire system works together to produce reliable results. System Suitability Tests (SST) are common in analytical chemistry to complement Preventive Maintenance and Calibration.
They verify that an analytical system works correctly before sample analysis. These tests assess key performance indicators such as resolution, retention time, peak shape, and system precision, confirming that the system is fit for its intended use.
For titration systems, METTLER TOLEDO GSST includes:
By integrating system suitability testing, laboratories can verify seamless component interaction, meet regulatory expectations, and maintain confidence in their analytical results. This essential step ensures that instruments and methods remain fit for purpose, preventing costly errors and reinforcing the reliability of laboratory data.
Even when an instrument is installed correctly and its components are qualified, the system’s ongoing suitability for specific methods must be verified. Changes in instrument condition, environmental factors, or procedural inconsistencies can compromise results. SSTs bridge the gap between instrument performance and real-world application, ensuring the complete system performs as expected.
METTLER TOLEDO focuses on Computerized Systems Validation (CSV) as a logical addition to our instruments and laboratory control software offering. We help our customers comply with regulations such as US FDA Title 21 CFR Part 11, EU GMP Annex 11, and others.
CSV is a detailed process mainly consisting of three different steps:
While customers are responsible for CSV, METTLER TOLEDO supports this process with comprehensive Validation Manuals. These manuals are split into:
Since PQ is specific to the end-user business process, the customer is responsible for the definition and execution of this part.
All in all, the Validation Manuals 2 offer a structured approach to documenting validation procedures and outline key validation topics, including:
Our LabX Software System Validation Service helps customers meet user requirements and regulatory expectations. It provides structured validation documentation to comply with regulations such as FDA 21 CFR Part 11, EU GMP Annex 11, etc.
Each process ensures accuracy, reliability, and compliance. This comparison clarifies their roles for optimal lab equipment performance.
| Process | Purpose | Key focus | Examples of Applications |
| Qualification | Ensures that newly installed equipment is appropriately set up and fit for its intended use. | Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ). | Verifying a new analytical instrument or relocating existing equipment. |
| Calibration | Determines measurement accuracy by comparison to a reference standard. | Measurement traceability, measurement accuracy, and adjustments when necessary. | Routine calibration of balances, pipettes, and temperature-sensitive instruments. |
| Verification | Confirms that an instrument continues to meet operational performance criteria over time. | Periodic assessments and compliance documentation. | Regular testing of pH meters or moisture analyzers to ensure accuracy. |
| System Suitability Testing (SST) | Ensures the entire analytical system (instrument, software, necessary accessories and method) performs correctly before use. | Whole system performance check, adherence to regulatory guidelines. | Performing METTLER TOLEDO General System Suitability Test (GSST) for titrators. |
| Validation | Confirms that processes and software systems function correctly and consistently for their intended use. | Process validation, software compliance, and regulatory documentation. | Validating LabX software for compliance with FDA 21 CFR Part 11 and EU GMP Annex 11. |
Our expert METTLER TOLEDO technicians support and service your laboratory equipment throughout its entire lifecycle, to meet your specific needs and requirements.
Why METTLER TOLEDO Service is different?
More than 50 countries and 1 500 technicians
Tailored solutions throughout your entire equipment's life cycle
Harmonized and audit-proof procedures
Manufacturer's expertise and spare-parts reliability
In more than 50 countries
Head of Laboratory Service
With more than a decade in service and equipment lifecycle management, Sasha leads the development of innovative service solutions for evolving hardware and software systems for laboratory environments. Focused on efficiency, reliability, compliance, and customer satisfaction, Sasha integrates smart strategies and transformative service solutions to ensure lab managers can seamlessly achieve their research, quality control, and productivity goals.
