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Case studies

Measured results, achieved on the shop floor

Backlogs cleared, lead times shortened, inspection findings closed: discover how pharmaceutical sites have transformed their Quality with us, with the figures to prove it.

All case studies

Deviation management

Deviation backlog divided by 5 in 7 months, after a major inspection finding

Pharmaceutical CDMO · production site in France · 2025 – 2026

−79 %overdue deviations
−41 %processing time
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Deviation management

Deviation system redesigned across 4 sites: 64% fewer minor deviations

Biopharmaceutical group · headquarters and 4 sites in France · 2024 – 2025

−64 %minor deviations
−42 %major deviations
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Deviation management

45% fewer major deviations and an ANSM CAPA closed

Pharmaceutical company · 2 production units in France · 2025 – 2026

−45 %major deviations
−31 %deviations in total
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Batch records

From 0 to 90% of records right first time, and 65% less data

CDMO · solid dosage forms · 600-person site

0 → 90 %right first time
−65 %data
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Batch records

From 10% to 81% of records right first time on the move to commercial

Biologics production site · 50 people

81 %right first time
14simplified records
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Batch records

Up to 50% shorter batch record throughput time in 8 months

CDMO · sterile liquid dosage forms · 300-person site

−30 to −50%throughput time
3units managed
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Batch records

Batch records praised by inspectors, clearer and closer to the shop floor

Biologics production site · 700 people

13records coached
2025positive inspection
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Quality system management

Deviation backlog from 20 to 2 and no more overdue CAPAs, thanks to short rituals

API manufacturer · site of about 800 people · 2021 – 2022

20 → 2overdue deviations
5 → 0CAPAs closed late
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Quality system management

From 45% to 30% of deviations older than 30 days in one month of management

Pharmaceutical production site · 2 entities · 2019 – 2022

45 → 30 %deviations older than 30 days
35 → 27 daysaverage age
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Quality system management

Daily management to regain control of more than 700 deviations a year

Pharmaceutical company · injectables unit of about 200 people · 2023 – 2025

23 → 16overdue deviations in 1 month
−4 to 5 daysprocessing time
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Batch release flow

€6M of stock released and an anomaly backlog almost halved

Pharmaceutical CDMO · 2 production sites in France · 2023 – 2025

−€6Mblocked stock
−49 %overdue anomalies
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Human error

47% fewer “human error” deviations in 6 months

Clinical R&D site of about 1,000 people · packaging and distribution · 2023

−47 %human-error deviations
157weak signals reported
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Change control

Change control: 697 actions brought back under control in one summer

Pharmaceutical site of an international group · solid and liquid dosage forms · 2022

697actions under control
3 wksto launch management
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Quality culture

One day to bring meaning back to Quality: 96% satisfaction

Pharmaceutical production site in Switzerland · oral dosage forms and packaging · 2026

96 %satisfaction
5sessions in 1 week
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Quality organisation

A process-based organisation: twice as much autonomy in the pilot workshop

API manufacturer (CDMO) · pilot workshop of 20 people · 2022

× 1.9activities handled autonomously
85 %day-to-day autonomy
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Documentation and training

Documentation: from a 1-in-4 to a 7-in-10 chance of finding the right information

Implantable medical device manufacturer in Switzerland · two assembly lines · 2020 – 2021

1 in 4at the start
≈ 7 in 10target
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What would the result be for you?

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