Bring efficiency back to your lab: How aging technology hinders ideal performance

In this series, we review considerations for keeping your lab at the forefront of science. As we adjust to living and working in a pandemic and anticipate future global and geopolitical events, Waters remains dedicated to supporting your business and unlocking the potential of your science. Our holistic separations solutions and expert support help you innovate faster, more collaboratively, and more confidently. We’ll be sharing our considerations through our blogs, and would value hearing yours.

How much is your technology costing you?

Tried, true, and trusted. Your liquid chromatography (LC) system has served as your workhorse for years.

Over time, it becomes challenging to realize incremental value from your original investment. Your system’s value lessens as:

• Your security and compliance requirements grow
• Your testing demands increase
• The amount of data you manage multiplies

These all put pressure on your ability to ensure the quality of each analysis. At some point, it will be time for you to upgrade, but when is the right time, especially when your instrument might not be fully obsolete?

Following are some practical considerations to help you decide whether upgrading your technology makes smart business sense:

Is your chromatography data system obsolete?

Software is typically the first part of your instrument to become obsolete and its operating system is its heart and soul. The operating system manages your instrument’s processing and memory, as well as all of its software applications, including your chromatography data system (CDS).

Consolidation resulting from mergers, acquisitions, and restructuring is leaving many organizations with a sizable number of disparate instruments, outdated operating systems, and CDS brands that may no longer be supported by the manufacturer.

A recent Waters research finding indicated that lack of CDS system support ranked as the key driver to system replacement.

Outdated operating systems and software bring about a host of security and operational issues:

• Some instruments are unable to migrate to a Windows® 10 operating system, which requires that they remain on Windows 7. On January 14, 2020, Microsoft® discontinued support for Windows 7, which means there are no further software updates, including important security updates.
• If a part is needed for your IEEE instrument and it’s not available, the useful life of your system has effectively run its course – a tenuous place to be if it is a critical system to your productivity and business.
• As discovery and development workflows become increasingly collaborative and part of virtual environments, your laboratory’s infrastructure becomes more vulnerable to cybersecurity attacks. Older instrumentation can put you at a higher risk of malware, data breaches, and data theft.

If your instrument and your software are running on an outdated and/or unsupported operating system, and you want to avoid downtime and security risks from viruses or hackers, now would be a good time to upgrade. This is especially true for laboratories operating under FDA protocols, which require proof that both the operating system and all the software being used are current and incorporate the necessary firewalls. Waters systems uphold high levels of security within your lab and in the cloud and are synonymous with quality separations. Our new FlexUP Technology Renewal Program ensures you can easily and cost-effectively benefit from ongoing seamless upgrades to our latest LC and mass spectrometry instrumentation and software, eliminating the issues associated with outdated instrumentation.

Are you looking for confidence in compliance?

It takes time, money, and resources to generate your laboratory’s data, and your instrument and its software are your data’s lifeblood. Compliant data is the name of the game. Any loss or compromise of your data over its lifetime is a key compliance risk and a direct financial loss to your organization.

From the perspective of global regulators, your system needs to meet several functionality thresholds, including:

• Software and instrument configuration documentation
• Instrument qualification
• Metadata use and archival
• Audit trail functionality
• Compliance control for unattended working

Assuring regulatory authorities that your chromatography data supports the quality and consistency thresholds for your product is a substantial and costly undertaking.

As techniques and technologies across research, development, and manufacturing grow, more complex data is being generated. Regulatory authorities are continually modifying their guidelines, requiring you to keep up with the latest revisions.

As regulations continue to evolve, and if you are concerned about your system’s compliance status –seeing more of your time being spent on instrument qualification software validation than on your actual analysis – now would be a good time to upgrade. Waters offers an extensive portfolio of solutions, including industry-leading and easy-to-use Empower™ CDS, which seamlessly supports stringent compliance requirements in lab-based and cloud-based environments. All Waters Analytical LCs arrive at your lab Empower-ready.

Data quality matters

Data quality is critical in the decisions that support the safety and efficacy of your products. Whether managing data from one LC or hundreds, data needs to be durable, secure, and accessible to inform product quality assessments at the time of decision-making and for the full duration of the mandated retention period:

• Regulatory observations in pharmaceutical laboratories routinely cite concerns regarding the reliability of analytical methods, especially chromatographic methods, requiring your time to intervene, adjust, or repeat testing.
• Whether you are developing brand new methods, evaluating ways to improve the performance of your existing method, or looking for ways to ensure the continued reliability of your ongoing routine analyses, the quality of every analysis counts.
• Inspired by a suite of new ICH guidelines, many scientists today are managing their methods using a lifecycle approach for improving the consistency, ruggedness, and quality of their separations and enabling right-first-time analyses. Development and deployment of these analytical methods to modern, routine-use HPLC platforms mitigates the risk of invalidated data, continually adjusted or manual peak integration, and system suitability failures.

If you are concerned that your analytical method’s performance might be playing a role in data quality shortcomings, now would be a good time to upgrade. Our newest LC, the Arc HPLC System, is designed to receive your transferred methods seamlessly and run existing HPLC methods with improved robustness and precision over traditional HPLCs, avoiding system suitability failures and the out-of-specification of results. When paired with the appropriate Waters column technologies and Empower CDS, you’ll experience robust performance in routine analysis, facilitating data review, eliminating burdensome quality and compliance documentation, and improving the overall quality of your data.

When is it time to upgrade?

Your lab is on a tight budget with competing demands as your needs for security, compliance, efficiency, and quality grow.

There is no better time than now to take a look at the hidden costs of maintaining your older instrumentation. The gains that you’ll realize from reducing lab staff intervention and manufacturer’s service time, along with your newfound instrument uptime, improved capacity, and overall lab efficiency improvements will likely outweigh your investment in new instrumentation. There is no measure for the added confidence you’ll feel knowing that, as your testing needs change and grow and as compliance requirements evolve, you and your lab will be ready to take on what’s next.

What’s next from us? Your Waters team is ready to help by providing a complete assessment of your current technology and an evaluation of any potential business and/or compliance issues. Contact us today to discuss whether upgrading your technology makes smart business sense.

Learn more about our FlexUP Technology Renewal Program here.
Learn more about our full line chromatography systems, including the Arc HPLC here.
Learn more about Empower CDS here.