Challenge
A leading biotechnology company had to address cybersecurity and compliance gaps in its manufacturing and quality control sites. Out-of-date operating systems and instrument software left critical laboratory systems exposed, and the company needed to migrate to a more secure network. This was a very high-profile effort — one of the company's top three corporate objectives — with a global timeline that was visible at the top level and dates that could not be missed.
The Quality Control Instrument Resiliency (QCIR) project was initiated for this global migration, encompassing upgrades to over 600 systems including Chromatography Data Systems (CDSs), Laboratory Execution Systems (LES), Laboratory Information Management Systems (LIMS), and Chemical Inventory Management Systems (CIMS). The scope demanded tight coordination between the project team and infrastructure, network, and security functions across corporate and individual sites, including external support providers.
Approach
USDM Life Sciences provided expert technical guidance, business analysis, validation strategy and guidance, and troubleshooting for this ambitious project. Our work spanned program management, technical support, validation, quality approval, and global training.
Program Management
USDM developed a multi-year plan with targets that aligned with the global timeline. Because the dates had top-level visibility and could not be missed, the global team stayed very hands-on to facilitate coordination between the project team and infrastructure, network, and security — across corporate, sites, and external support providers.
Technical Guidance and Support
USDM offered in-depth technical guidance for instrument connections, instrument configurations, and software configurations that improved system resilience and efficiency. We provided subject matter experts who understood the CDS, LES, and LIMS systems to help the company meet its backlogged business requirements for enhancements, and we helped develop a repeatable playbook for each site to follow.
Validation Strategy and Guidance
USDM developed a global validation approach, providing guidance, support, and global templates for the local upgrade projects. We applied a risk-based approach — consistent with computer software assurance (CSA) thinking — to ensure the right level of testing for these critical systems while preserving 21 CFR Part 11 and data integrity requirements.
Quality Approval and Global Training
USDM ensured that all project elements met compliance requirements and the highest operational standards. We also contributed valuable input for global training programs on CDSs and other crucial instruments so employees could use the upgraded systems effectively.
Solutions Delivered
- Robust framework for system support and upgrade: For the company's critical laboratory systems, USDM reviewed release notes, qualified laboratory equipment, added new instruments, refined methods, and created reports.
- Validation managed services: Application lifecycle management (ALM) support was essential for new and existing analytical equipment and instrumentation to ensure regulatory requirements and operational standards were met.
- Change control: Ongoing change control support included impact assessments, quality approvals, and tracking mechanisms to help remediate security vulnerabilities — a discipline that extends naturally to third-party risk management across external support providers.
- Strategic multi-year planning: USDM gave the company's manufacturing sites a plan to upgrade analytical instruments, improve operational efficiency, and support their overall quality control compliance strategy, along with an Agile framework featuring project dashboards and reports.
Results
With USDM's support, the company reduced compliance and cybersecurity gaps caused by out-of-date operating systems and instrument software, and met one of its top three company-wide corporate objectives. A periodic review process and an upgrade cadence were implemented to ensure longevity, turning a one-time migration into a sustainable, repeatable practice.
This project is a testament to USDM's expertise in meeting an extremely critical and visible timeline, managing complex multi-site laboratory system upgrades, and sustaining quality control and resilience in the biotechnology industry. To keep your own QC lab systems secure, validated, and inspection-ready over time, explore USDM's continuous compliance managed services.