Sectors / Pharmaceutical / Tosara Pharma – Regulatory Training Case Study

Case Study · Pharmaceutical

Tosara Pharma: 70% savings on regulatory training per employee

An employee transformed the regulatory training process from a handwritten, time-consuming system to a computer-based approach — delivering trial savings of over 70% per employee per year.

Pharmaceutical Lean Practitioner Value Stream Mapping Process Mapping Standard Work

Industry

Pharmaceutical / Consumer Healthcare

Programme

Lean Practitioner

Location

Baldoyle, Dublin

70%+

Savings per employee per year on training

Digital

Computer-based training replacing handwritten

VSM

Value Stream Mapping used to assess impact

The Problem

Regulatory training: time-consuming, handwritten, and inefficient

Tosara Pharma — the Dublin-based manufacturer of Sudocrem, sold in over 50 countries worldwide — has been on a Lean journey since 2009. Employing 92 people at their Baldoyle facility, the company was voted Enterprise Ireland Lean Business of the Year 2018, recognising their commitment to continuous improvement.

An employee identified that the regulatory training process was a significant source of waste:

All training records were handwritten — time-consuming to create, maintain and reference
The process was inefficient — consuming disproportionate staff time relative to the value delivered
No easy way to verify training completion or compliance status across the workforce
Handwritten records created legibility and accuracy risks — problematic for a regulated pharmaceutical environment
The volume of regulatory training required across 92 employees made the manual approach unsustainable as the company grew

The employee saw an opportunity to assess the impact of computer-based training as a replacement for the handwritten system.

INSERT PHOTO — client workspace, team meeting, or relevant image

The Journey

From handwritten records to digital training with measurable savings

Challenge

Key Challenges

The team needed to:

Assess the time and cost impact of replacing handwritten training with computer-based training
Map the current training process to quantify the waste
Trial a computer-based approach and measure the results
Ensure the new system met all regulatory and compliance requirements
Create a scalable solution for 92 employees across the facility

Solution

The Lean Solution

Using Value Stream Mapping to map the current state and assess the impact:

Value Stream Mapped the full regulatory training process — from training identification through delivery to record completion
Quantified the time spent on handwritten record creation and maintenance
Designed and trialled a computer-based training approach
Measured trial results against the current-state baseline
Assessed savings per employee per year across the full workforce

“The Lean Manufacturing tools (5S and Kaizen) and concepts will provide measurable profits.”
— Tosara Pharma

Our Approach

8-Step Problem-Solving Process

Value Stream Mapping was the primary tool — it provided the data needed to compare the current handwritten process against the proposed computer-based alternative, quantifying the savings objectively.

Problem

Regulatory training is handwritten — time-consuming, inefficient, and risky for a GMP pharmaceutical environment.

Current State

Value Stream Mapped the full training process. Quantified time spent on handwritten record creation and maintenance per employee.

Target

Computer-based training system. Significant reduction in time per employee. Maintained regulatory compliance.

Root Cause

Root cause: no digital training system. All records handwritten. No automated compliance tracking or verification.

Countermeasures

Designed computer-based training approach. Trialled with selected employees. Measured time savings against handwritten baseline.

Implementation

Trial implemented and measured. Results compared against Value Stream Map baseline. Savings quantified per employee per year.

Evaluation

Trial results showed savings of over 70% per employee per year. Computer-based training proven to be faster and more reliable.

Standardisation

Computer-based training adopted. Regulatory compliance maintained. Scalable to all 92 employees across the Baldoyle facility.

INSERT PHOTO — process artifact, team, or results visual

Key Outcomes

Over 70% savings — per employee, per year

The trial delivered clear, measurable results:

Over 70% savings per employee per year. The computer-based approach dramatically reduced the time required for regulatory training — a saving that compounds across 92 employees.
Handwritten records eliminated. Training records are now digital — legible, searchable, auditable, and compliant with GMP requirements.
Compliance visibility improved. Training completion status can now be verified instantly, rather than searching through paper records.
Scalable solution. The system works for the current workforce of 92 and can scale as the company grows.
Part of a broader Lean culture. This project was one of multiple employee-led improvements at Tosara — contributing to their Enterprise Ireland Lean Business of the Year 2018 award.

Learnings

Value Stream Mapping provided the objective data needed to make the case for change — without it, the proposal would have been based on opinion rather than evidence.
The savings compound dramatically across the workforce — 70% per person multiplied by 92 employees represents a massive annual return.
Digital training isn’t just faster — it’s more reliable for a pharmaceutical environment where regulatory compliance is non-negotiable.
This project was part of Tosara’s broader Lean journey that began in 2009 — consistent investment in employee-led improvement eventually won them national recognition.

Conclusion

The company that won Lean Business of the Year

Tosara Pharma’s regulatory training project is one example of the continuous improvement culture that earned them Enterprise Ireland’s Lean Business of the Year 2018. Since 2009, the company has systematically empowered employees to identify and solve process problems — from regulatory training to production line operations. The result is a manufacturing operation that combines pharmaceutical compliance with Lean efficiency.

LeanTeams has worked with Tosara Pharma since 2009. You may also be interested in: Tosara Pharma – Operational Excellence. All our case studies are available on our sectors page.

Tools & Approaches Used