Case Studies
Case Studies
Proven Results That Deliver Impact
We focus on delivering measurable improvements that make a real difference to laboratory performance, efficiency, and quality.
Case Study 1: Inspection Remediation
Challenge
Site that had failed 2 FDA PAI with around 40% observations in QC
Approach
Train and empower team to own observations and remediate
Result
- Cross trained multli skilled empowered team
- Improved compliance especially around data integrity
- Zero observations in QC from both FDA and EU PAI inspections
Case Study 2: Stability Compliance Improvement
Challenge
Release samples consistently prioritised over stability leading to multiple stability deviations
Approach
Performance assessment to understand bottlenecks and lean lab process to balance mixed value flow line
Result
- Improvement of stability testing compliance from 50% to >95%
- Shorter, consistent and reliable cycle times for both release and stability
- Clear insight into lab capacity improving stability planning
Case Study 3: Improve Lab Productivity
Challenge
To absorb a 10% increase in release volume with no increase in headcount
Approach
Review testing strategies and QC Quality systems to simplify and standardise as well as Lean Lab principles of pull rather than push
Result
- Release volume absorbed with no increase in head count
- Clear insight into lab capacity to make informed resourcing decisions
- Simplified quality system for QC
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These Results in Your Lab?
Let’s identify where your biggest opportunities lie and turn them into measurable success.