The Importance of Qualification for Laboratory Instruments and Software: Ensuring Accurate Results

Optimal instrument performance—why is it necessary?

Laboratory instruments are essential tools that enable scientists to progress scientific research and produce cutting-edge products by obtaining accurate and reliable data. However, the performance of these instruments can become compromised over time due to improper maintenance, general wear and tear, and other issues, resulting in the production of inaccurate results. Examples of compromised instrument performance include:

• Lack of calibration: Some instruments like balances and pH meters must be regularly adjusted to ensure they are producing readings within a specified tolerance (calibration). If these instruments are not calibrated correctly, the readings they produce may be inaccurate and unreliable
• Lack of qualification: Some instruments like HPLC and GC must be regularly qualified to ensure that they are producing readings within a specific tolerance to ensure reliability and accuracy of the data they generate.
• Lack of computer system validation: Computerized systems should be validated to ensure data integrity by holistically testing the hardware, software, and business applications against user requirements. If this regulatory requirement is not fulfilled, computerized systems may produce inaccurate results or fail, causing serious repercussions.
• Ineffective preventive maintenance: If instruments are not properly maintained, instrument malfunction or failure can occur or may even go undetected. This can not only cause unexpected downtime and repair costs but also impact the accuracy of results.
• Improper cleaning: Following regular cleaning procedures can keep instruments in optimal condition. However, if an instrument is not effectively or regularly cleaned, it could transfer contaminants to samples and compromise results.
• General wear and tear: Heavy use of instruments can, over time, lead to wear and tear of parts. Not regularly inspecting instrumentation could result in these parts going undetected, ultimately impacting instrument performance.

Even if your instrument appears to be working normally, its performance should be qualified regularly to ensure your lab is obtaining accurate data.

What is an instrument qualification?

Qualification is the process of verifying and documenting that laboratory instruments and software are functioning correctly and producing accurate results. The qualification process involves testing and validating the performance of instruments and software against established standards and user requirements.

Why is accuracy so important?

As mentioned previously, if your laboratory equipment and instruments are not calibrated or qualified properly, or are not working at their optimum, they are at risk of producing inaccurate data. Even if they seem to be working as normal, instrument qualification guidance and user requirements can change, impacting your instruments and invalidating the results they provide. For analytical results to be valid, an instrument must be suitable for its intended use. The consequences of inaccurate or invalid results are serious and include:

• Misleading conclusions and erroneous scientific interpretation
• Wasted time and resources
• Failure to comply with regulatory requirements, leading to loss of license
• Damaged reputation of laboratories and companies
• Legal and financial liabilities

By performing regular qualification, labs can identify and address potential issues before they become major problems. Regular qualification also helps labs to stay compliant with regulatory requirements and standards. This is particularly relevant for pharmaceutical labs, which must demonstrate suitability during audits and inspections.

Another important regulatory requirement after qualification of instruments that has been showing up in FDA audit reports is ensuring data integrity in the laboratory. In such cases, computer system validation, which is applicable to the computer systems connected to the qualified instruments, need to be validated to ensure that data is secure and meets regulatory guidelines to ensure data integrity. To do this, the hardware, software, and business applications of computer systems must be validated against user requirements.

How regularly should qualification be performed?

How frequently you need to perform qualification depends on many factors:

• Regulatory requirements: Industries like pharmaceuticals, biotechnology, and environmental monitoring are subject to strict regulatory standards, which may specify how often certain types of instruments should be calibrated and qualified.
• Manufacturer recommendations: Manufacturers may have recommendations for how often their instruments should be calibrated and qualified to ensure optimal performance.
• Instrument criticality: Critical instruments and software typically play a crucial role in ensuring accuracy, reliability, and integrity of results within processes that strictly require precise measurements and minimal variability. Therefore, these instruments require qualification more often than less- critical instruments.
• Frequency of use: Instruments that are used more frequently than others will require qualification more often.
• Environmental conditions: Factors such as temperature, humidity, and contaminant exposure can impact instrument performance; thus, instruments exposed to more extreme conditions may require more frequent qualification.
• Updates: Instrument or software updates can affect operation and processing of data. Therefore, it is recommended that the instrument or software is requalified after an update.
• Changes to lab infrastructure or equipment: If a lab undergoes renovation or installs new equipment, these alterations may impact the lab environmental conditions and necessitate requalification.
• Process or method changes: Alterations to experimental methods and processes may alter the intended use of an instrument, requiring requalification to ensure compliance.

Ultimately, there is no one-size-fits-all approach to establish a suitable qualification schedule—instead, careful consideration of a range of factors is required.

Can qualification be performed in-house?

Labs can perform qualification of their instruments in-house, which may offer cost savings and the ability to tailor the qualification process to the specific needs and workflows of the laboratory. However, to choose this approach, the following challenges and considerations must be taken into account:

• Training of personnel: To perform qualification in-house, personnel must be qualified to carry out the process accurately. This may involve the implementation of regular training, which costs time and money, and requires careful planning.
• Standards, equipment, and traceability: Labs must have access to nationally or internationally recognized standards and suitable equipment to perform qualification. Traceability of measurements to these recognized standards must be established to ensure reliability and accuracy of qualification results.
• Documentation: It is crucial that a good documentation process is established before performing qualification in-house. Labs that rely on the use of paper- or spreadsheet-based qualification protocols create data integrity risks from human error, manipulation of results, and more.
• Excess of information: The high number of data integrity guidance documents now available contributes to many labs being overloaded with information and struggling to implement compliant qualification solutions in a timely manner.
• Avoiding a one-size-fits all approach: As mentioned previously, determining the frequency of qualification requires consideration of several factors. Furthermore, using a one-size-fits all qualification approach, such as a service vendor’s standard protocol alone, can be a risk, as it may not fit your labs specific user requirements or satisfy the range of use of your instruments—which are both essential for compliance.

While many labs decide to perform qualification internally, other labs—particularly those in highly regulated industries—may choose to outsource their qualification to a professional service provider.

What are the benefits of employing a professional service provider for qualification?

The benefits of hiring a professional service provider like Agilent to perform instrument qualification include:

• Expertise and experience: Professional service providers are highly trained and experienced to perform qualification and have familiarity with a wide range of instrumentation, increasing confidence in qualification results. This also means that labs will not have to organize qualification training for their staff, saving time and money.
• Traceability: A professional service provider will maintain traceability to nationally or internationally recognized standards to ensure qualification results are reliable and accurate.
• Specialized equipment and software: Professional service providers usually have access to state-of-the-art equipment and software for qualification to ensure accuracy. This also negates the need for a lab to purchase this equipment itself.
• Time savings: Employing a professional service provider can save you time training staff, creating a qualification schedule, performing qualification, and writing reports. Instead, a professional service provider will perform qualification and generate a report for you.

Why choose Agilent for qualification services?

Independent surveys have shown that qualification services provided by Agilent are recognized globally as number one. Our qualification services are:

• USP <1058> compliant: Agilent qualification services are designed to be compliant with USP <1058>. The USP is the only major pharmacopeia with a chapter dedicated to analytical instrument qualification.
• Multiplatform: Agilent provides one of the widest ranges of electronic qualification services in the industry. Our qualification services can be performed on many types of instrumentation and software.
• Multivendor: Our qualification services are not limited to Agilent instrumentation. Our experts are trained to perform qualification on a range of both Agilent and non-Agilent instruments and software.
• Customized: Agilent offers custom qualification solutions that are specific to your user requirements, minimizing compliance risks during regulatory inspections.
• Harmonized: We deliver harmonized qualification services globally using Agilent Automated Compliance Engine (ACE) software, which uses electronic protocols and reports to ensure qualification services are configurable to laboratory requirements in a compliant and efficient way.
• Data integrity assured: Our experts can install network-distributed ACE within your networked firewall to provide assured ALCOA+ data integrity compliance during analytical instrument qualification.

Keep your lab compliant and results accurate

Optimal performance of laboratory instrumentation is crucial for accurate data and scientific progress. Compromised instrument performance can result in inaccurate data, triggering serious repercussions from wasted time and resources to legal and financial liabilities. Qualification is essential to ensure that laboratory instrumentation is performing correctly and in compliance with regulatory requirements, preventing these serious consequences.

Although performing qualification in-house offers some potential benefits, outsourcing to a professional service provider like Agilent can offer several advantages over in-house qualification. By partnering with Agilent, you can leverage the expertise from a recognized leader in analytical instrument qualification, and benefit from multivendor, multiplatform, harmonized qualification services to ensure your lab is compliant and performing optimally.

If you are unsure whether your lab instruments and computer systems are compliant, or if any of your instruments need qualification, contact our lab services experts to find out more on how they can help you achieve your laboratory compliance goals.