Staying Current: Why Upgrading Matters for Your Lab’s Future

In the fast-paced world of life sciences, staying current isn’t just a best practice, it is a necessity. As technology evolves, so do the risks of your lab falling behind and risking non-compliance with CGMP standards. With general releases of Windows® 10 reaching end of support on October 14, 2025,¹ now is the time to ensure your lab is prepared for the future and ensure both your operations and data are safe.

The Clock is Ticking on Windows 10

Microsoft officially announced that Windows 10 will no longer receive security updates or support after October 2025. Should a regulated organization opt to remain on Windows 10 past the support date, it is critical that you have a documented risk assessment following the principles of ICH Q9 with robust and ongoing vigilant monitoring to ensure data is not compromised.

For laboratories operating in regulated environments, this presents significant risks, including:

• Security vulnerabilities will no longer be patched.
• Compliance risks increase as unsupported systems fall out of regulatory alignment.
• Operational disruptions may arise from incompatibility with newer software and hardware.

The Risk of Falling Behind

Running outdated infrastructure makes you a prime target for cyberattacks.² In a regulated laboratory, the potential for data loss has not only an operational impact, but also serious implications with respect to data integrity should data no longer be available for the full retention period required. Staying on unsupported operating systems, as well as applications, increases your risk of non-compliance.

“15.10. Updated platforms. Operating systems and platforms for applications should be updated in a timely manner according to vendor recommendations, to prevent their use in an unsupported state.

15.11. Validation and migration. Validation of applications on updated operating systems and platforms and migration of data should be planned and completed in due time prior to the expiry of the vendor’s support.” – The Draft Guideline: Revised Annex 11 – Computerized Systems³

Outdated software puts your data at risk and can expose your lab to:

• Cybersecurity threats targeting unpatched vulnerabilities
• Data loss issues and unauthorized access compromise data integrity
• Audit failures due to non-compliance with GxP or other regulatory standards

Why Upgrade to Windows 11?

Maintaining current infrastructure helps you to keep your data safe and is important for disaster prevention. Leveraging Windows 11 ensures you are supported and helps you to better cope with ongoing security threats. Staying current with your operating system also enables you to align with regulatory expectations.

“Operating systems and network components (including hardware) should be updated in a timely manner according to vendor recommendations and migration of applications from older to newer platforms should be planned and conducted in advance of the time before the platforms reach an unsupported state which may affect the management and integrity of data generated by the system.” – PIC/S Data Integrity Guidance³

Windows 11 offers secure architecture for your regulated environment, including:

• Enhanced security architecture with TPM 2.0 and virtualization-based protection
• Improved performance for data-intensive applications
• Improved security with modern security standards compatibility
• Enhanced data reliability to support compliance with data integrity and security expectations by addressing newly identified vulnerabilities with updates

Empower Software and Windows 11: Stay Current and Confident

Waters supports your commitment to data integrity and compliance. Our Empower Software (versions 3.9.0 and up) offers full, tested support for Windows 11, to ensure:

• Seamless performance on modern hardware
• Enhanced security
• Ongoing support aligned to maintain a state of control

This alignment helps laboratories meet regulatory expectations for validated systems, secure data environments, and long-term reliability across the software lifecycle.

How Waters Can Help

Upgrading can be complex and time consuming. From assessing the impact of updates to validating changes, our experts help you navigate each stage as you strive for continued compliance, including:

• Windows 11 readiness assessments for your Empower Software environment
• Migration planning and validation support tailored to your organization
• Expert guidance to ensure compliance and minimize downtime

Waters is here to support your journey—because innovation starts with a strong foundation. Stay current, stay secure, stay ahead of the competition and speak to a Waters representative today about upgrading your Empower Software.

参考文献

1. https://support.microsoft.com/en-us/windows/windows-10-support-ends-on-october-14-2025-2ca8b313-1946-43d3-b55c-2b95b107f281
2. https://www.waters.com/content/dam/waters/ja/library/white-papers/2020/waters-whitepaper-DurableDataforNonITALabManagersGuidetoEnsuringYourEmpowerDataIsSecureandAvailablefromCreationThroughtheFullMandatedRetentionPeriod-720006866.pdf
3. https://health.ec.europa.eu/document/download/40231f18-e564-4043-94de-c031f813d38b_en?filename=mp_vol4_chap4_annex11_consultation_guideline_en.pdf
4. https://picscheme.org/docview/4234