QC Compliance Managed Services for a Global Biotech Company

A leading biotechnology company had to address cybersecurity and compliance gaps in their manufacturing sites. This included upgrading out-of-date operating systems and instrument software but also migrating to a more secure network. This was a very high-profile project as it was one of the top three corporate objectives.

The Quality Control Instrument Resiliency (QCIR) project was initiated for this global migration that included 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). USDM Life Sciences provided expert technical guidance, business analysis, validation strategy and guidance and troubleshooting for this ambitious project.

PROJECT SCOPE

Program Management: USDM developed a multi-year plan with targets that aligned with the global timeline.  This timeline had visibility at the top level and the dates could not be missed.  The global team had to be very hands on to facilitate coordination between the project team and infrastructure, network, security across corporate and sites including 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.  USDM provided SMEs that understood the CDS, LES and LIMS system to help them meet the backlogged business requirements for enhancements.  We helped them develop a repeatable playbook for each site to follow.

Validation Strategy and Guidance: USDM developed a global validation approach providing guidance and support to the sites including global templates for the local upgrade projects. USDM used a risk-based approach to ensure the right level of testing for these critical systems.

Quality Approval: USDM ensured that all project elements met compliance requirements and the highest operational standards.

Global Training: USDM contributed valuable input for global training programs on CDSs and other crucial instruments to ensure that 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: The ALM support in the project scope was essential for new and existing analytical equipment and instrumentation to ensure that regulatory requirements and operational standards were met.

Change Control: Ongoing change control support included impact assessments, quality approvals, and establishing tracking mechanisms to help remediate security vulnerabilities.

Strategic Multi-Year Planning: USDM provided the company’s manufacturing sites with a plan to upgrade analytical instruments, improve operational efficiency, and support their overall quality control compliance strategy.  Additionally, USDM developed an Agile framework with project dashboards and reports.

OUTCOME

With USDM’s support, the company reduced compliance and cybersecurity gaps due to out-of-date operating systems and instrument software and met one of the top three company-wide corporate objectives. Additionally, a periodic review process and an upgrade cadence was implemented to ensure longevity.

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 their commitment to quality control and resilience in the biotechnology industry.