How a CDMO Keeps High-Pace Inspections on Track

Company Background

Lonza is a Swiss-headquartered contract development and manufacturing organization (CDMO) that partners with pharma and biotech companies worldwide. Its Houston-area site focuses on large-scale cell and gene therapy and viral vector manufacturing under strict regulatory oversight. During inspection weeks at the Houston location, inspectors can review almost every part of operations. Quality must respond in real time, pull the right evidence from multiple groups, and clearly assign ownership for each request so nothing is missed. Relying on scattered files and email threads makes it hard to stay organized and keep every answer accurate and traceable.

The Challenge

Quality Assurance at Lonza Houston is responsible for pulling records needed for inspection requests from every team being audited. Vanessa G., Quality Assurance Specialist IV, is often at the center of that effort. When inspections are active, requests arrive quickly and frequently need supporting evidence right away. QA is pulling information from several groups, confirming who owns each deliverable, and keeping inspectors updated while timelines stay tight. Before ACE Inspection, Vanessa and the team relied on Microsoft Teams chats and other communication tools to stay organized. Important updates could get buried, and ownership wasn’t always clear. They needed a better way to track requests in real time, keep inspectors informed, and cut down on the back-and-forth that builds during a busy audit.

How ACE Inspection Helped

Configurable to Lonza’s Processes

Lonza adopted ACE Inspection as a central library to manage inspection requests and evidence, adapting and integrating the system into the way the Houston team runs inspections. Vanessa emphasized that the system was set up with “customized workflows to meet [our] already established and working process,” rather than forcing a new approach. The configuration was supported by an onsite working session with the ACE team to walk through real inspection scenarios and align steps and responsibilities.

Portal That Keeps Everyone in Sync

Vanessa pointed to ownership as one of the biggest shifts. She said ACE helps “get the request assigners more involved” because requests go straight to the people responsible for fulfilling them, and it “shifts the responsibility for uploading the document to the person,” spreading the work across the team instead of bottlenecking with one audit lead. She noted that the team can easily tell when someone is working on a request and when it’s done, which helps inspections stay organized and on track without overwhelming back-and-forths.

Ongoing Partnership and Support

Vanessa highlighted the value of having a dedicated Account Manager who stays closely connected to the team with one-on-one support. Through ongoing check-ins, Lonza has been able to suggest adjustments that could help their team work more efficiently. That feedback helps the ACE team continue to refine the system, keeping it aligned with real-life customer workflows.

Results

After bringing the inspection tool into their processes, Lonza saw improvements in how inspections are managed:

• Customized workflows that match how inspections run onsite.
• Clear, shared accountability for every request.
• Continued collaboration with the ACE team to keep the process sharp.

“I would definitely recommend ACE as a software system to keep track of requests.”

–Vanessa G., Quality Assurance Specialist IV, Lonza

See what ACE Inspection Can Do for Your Team

Lonza uses ACE Inspection to keep inspections organized, accountable, and easier to manage during audits. If you want similar control and visibility, contact our team today to explore how ACE can support your next inspection.