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LabWare 5 to 8 LIMS Upgrade: Managing GMP Change for Non-LIMS Users

A global pharmaceutical company upgraded LabWare from version 5 to version 8. The project covered URS, FS, DS, validation, cutover, master data migration, and training for QC and QA users.

However, the upgrade also changed sampling plans and sample labels. This affected production, utilities, and support staff who never logged into LabWare but relied on its printed outputs.

After the upgrade, layouts changed, new information appeared, and familiar data moved. Yet operators still had to collect samples correctly, on time, and at the right locations.

The project team invited these employees to meetings. However, attendance was nearly zero because of workloads, shift schedules, and limited interest in the LIMS project.

Meanwhile, the upgrade had to continue, sample collection had to remain operational, and the PQS required documented change communication.

In this case, our team created a documented before-and-after communication package and distributed it through area heads and team leaders.

Challenges Faced

A detailed GAP analysis in Quality Management Systems is essential for identifying process deficiencies effectively.
  • Non-LIMS users were still affected: Production and utilities staff relied on printed LabWare sampling plans and labels without using the system directly.
  • Sampling plans and labels changed: LabWare 8 changed layouts, fields, and information positions, so operators needed clear guidance.
  • Live meetings had low attendance: Information sessions and walkthroughs reached few operators. Shift patterns, workloads, and scheduling conflicts limited participation.
  • Misunderstanding could affect GMP activities: Misreading sampling locations, frequencies, or labels could lead to deviations.
  • The project needed documented evidence: The project needed clear proof that non-LIMS users received the change communication.
  • Regulatory expectations covered impacted personnel: ICH Q10, EU GMP, and FDA guidance required structured change management, communication, and training.

Zamann Pharma Support’s Approach

  • Identify users of LIMS outputs: The impact assessment included employees who used labels, sampling plans, reports, and other LIMS outputs without accessing LabWare directly.
  • Create before-and-after visuals: The team compared LabWare 5 and LabWare 8 sampling plans and labels. It highlighted moved information, new fields, and unchanged process steps.
  • Use asynchronous communication: Because live meetings reached few operators, the team used a slide deck that employees could review on their own schedule and keep as a reference.
  • Work through team leaders: Area heads and team leaders received the material and were asked to share it with their teams. The project team remained available for questions.
  • Document distribution: The communication material and distribution trail became part of the change documentation.
  • Connect communication to change control: The approach documented impacted stakeholders, communication methods, training needs, and archived materials within the controlled change process.

Results Achieved

  • Operators received accessible guidance: Employees could review the revised sampling plans and labels even if they missed central meetings.
  • Operators had a contact point: The project team remained available for questions about the new formats.
  • Communication became documented evidence: The project retained the presentation and distribution trail within the change documentation.
  • The upgrade stayed on track: Asynchronous communication reduced the need to repeatedly reschedule poorly attended meetings.
  • The inspection explanation became clearer: The team could show who was affected, how communication was adapted, what material was distributed, and where evidence was archived. 
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FAQ

1. How should operators be informed when a LIMS upgrade changes sampling plans and labels?

Use before-and-after examples that show moved information, new fields, and unchanged steps. If live sessions are impractical, distribute the material through area heads or team leaders and retain evidence of communication.

 

2. What evidence should change control retain for non-LIMS users?

Retain the communication material, distribution records, documented follow-up, and relevant archived project documentation. In this case, the before-and-after presentation and its distribution trail formed part of the change documentation.

 

3. Why do non-LIMS users matter during GMP computerised-system changes?

They may perform GMP activities using system-generated outputs. In this case, production and utilities staff relied on printed sampling plans and labels even though they never logged into LabWare. Pasted text

 
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