Case Study 

Normon Laboratories Reduces Equipment Qualification
and Validation Times by 30% to 40% With ValGenesis

Customer Profile
Normon Laboratories is a leading
pharmaceutical company in Spain
specializing in the development,
manufacture, and distribution of generic
drugs. With five main divisions—Generic
Drugs, Hospital, Dental, OTC, and
International—Normon offers a wide
range of high-quality products, including
tablets, capsules, oral solutions, and
injectables. Its modern manufacturing
facilities are among the most advanced
in Europe, supporting its mission to offer
accessible and affordable healthcare
solutions worldwide.
Headquarters: Tres Cantos, Madrid,
Spain
Employees: More than 3,000
Founded: 1937

Case in Brief 

Normon Laboratories' diverse qualification and
validation needs, spanning computer system
validation (CSV), process validation, and equipment
qualification, required a versatile and effective digital
solution capable of managing all aspects of the
validation and qualification lifecycle. Because the
system is intuitive, easy to use, and robust, Normon
chose ValGenesis to streamline processes and
significantly improve efficiency across the board.

Results Highlights
• Equipment qualification times reduced
by 30 to 40%
• Laboratory equipment requalification times
reduced by 60%
• Real-time visibility eliminated documentation
“black holes” by making documentation easy
to locate at all times
• Accelerated approvals through parallel review
• 1.3-ton reduction in paper waste
• 270,000 fewer sheets of paper printed annually

"By reducing initial qualification times by 30 to 40
percent and equipment requalification times by as
much as 60 percent, we’ve significantly increased
efficiency, allowing us to complete more validations
without adding resources," said Carlos Villena
Morales, technician responsible for qualifications
and calibrations within the Quality Control and
Microbiology area of Plant Technical Services.

Weaknesses
of Traditional Validation

Plant Technical Services manages a wide range
of validation and qualification activities, including
laboratory equipment and room qualifications,
process validations covering hundreds of batches,
and cleaning validations for oral and injectable
products. The team is also responsible for aseptic fill
process simulations, which are critical to maintaining
stringent quality standards, as well as for central
computer systems validation, laboratory and factory
equipment, and multiple manufacturing areas that
require installation qualifications.

With such a wide range of responsibilities, relying
on paper-based processes slowed down operations
considerably. Manual workflows prolonged
lead times and limited visibility into the status of
documentation.

"One of the biggest drawbacks was the lack of
traceability of documentation. Documents were
misplaced or lost in ‘black holes’ during reviews,
causing delays in approvals and increasing
compliance risks," said Anja Bijedic Mitranic,
technician responsible for qualifications and
calibrations within the Quality Control and
Microbiology area of Plant Technical Services.

Another significant problem was the disproportionate
amount of time spent on documentation. Manual
data entry, fixing tests, and traceability management
took up more time than the validation work itself.
Long review and approval cycles diverted even more
resources from higher-value tasks.

Selecting the Ideal Validation Solution

Normon needed a validation system that could
replace paper-based processes with a modern,
digital approach. Equally important, the platform had
to be easy to use so validation teams would adopt it
without problems.

After evaluating multiple options, Normon selected
ValGenesis, recognizing its ability to provide:

• Real-time Traceability: The system provides realtime
tracking, ensuring that documents remain
visible and accessible at every stage of the
validation lifecycle.

• Improved Compliance Monitoring: Electronic
signatures, audit trails, and risk-based workflows
improve compliance and reduce administrative
burden.

• Optimized Document Management: Automated
approvals, configurable templates, and structured
workflows accelerate validation cycles and
improve operational efficiency.

• Future-Proof Scalability: The SaaS-based
architecture guarantees seamless integration
with Normon’s IT systems, providing the flexibility
needed for future growth.

• Streamlined Risk Management: A robust risk
management module simplifies and accelerates
risk assessment procedures, reducing complexity
and manual effort compared to paper-based
processes.

• Seamless System Adaptability: The system
integrates seamlessly into existing workflows,
allowing teams to maintain familiar
documentation formats such as Microsoft Word
while transitioning to a fully digital system.

"We chose ValGenesis becuase it's intuitive, easy to
use, and robust. The system was perfectly suited to
the way we work, which made the transition much
easier," said Bijedic Mitranic.

Efficient
Implementation

Ambit, a trusted ValGenesis implementation partner,
supported the deployment of the ValGenesis platform
at Normon. Taking a phased approach, the team
began with the qualification of laboratory equipment
in Phase 1. Consistent communication among
Normon, ValGenesis, and Ambit ensured alignment
throughout the process, contributing to a smooth and
successful deployment. Future phases will expand to
the plant and equipment qualification areas, as well
as CSV areas.

Implementation was further facilitated by the
standardized procedures for documentation
that already existed at Normon. The team had
standardized its documentation and processes
five years earlier, which made it easier to integrate
ValGenesis without major disruptions. The company
also dedicated significant time to training and
preparation, ensuring a smooth transition.

Streamlined Operations
and Measurable Results

Since implementing ValGenesis, Normon has
transformed its qualification and validation
processes. One of the most significant improvements
has been having absolute traceability of
documentation, knowing in real time what phase
the document is in and where it is. The system's
real-time tracking capabilities ensure that each
document remains visible and traceable throughout
the validation and qualification process. The ability
to track a document’s progress at any given moment
has drastically reduced the risk of misplaced or lost
files, providing auditors with immediate access to
relevant documentation.

Approval cycles have also become significantly
more efficient. Previously, manual document review
processes created bottlenecks, as reviews and
approvals had to be completed sequentially. With
parallel document review, multiple stakeholders can
evaluate and approve documents simultaneously,
drastically reducing approval times and accelerating
validation and qualification workflows.

The risk management module has further improved
efficiency by automating critical assessments.
Instead of performing manual calculations, teams
can now enter data directly into the system, which
instantly generates risk assessments. This capability
has reduced errors, standardized assessments, and
significantly shortened the time required for riskbased
decision-making.

"The risk management module is very fast," said
Villena Morales. "Normally, we would calculate
severity, detectability, and probability manually,
multiplying different factors. With ValGenesis, we
simply input the data, and it provides the result
automatically. For us, it's fantastic."

The time required for equipment qualification has
also improved significantly. Initial qualification times
have been reduced by 30 to 40 percent, while certain
types of equipment have seen reductions of up to
60 percent. By automating the entry of results and
tracking of tests, Normon has drastically reduced
manual validation efforts, allowing teams to focus
on higher-value tasks rather than administrative
burdens.

Beyond increased efficiency, the platform has had
a significant impact on sustainability. By eliminating
270,000 printed sheets of paper per year, Normon has
reduced paper waste by 1.3 tons and prevented 1,741
kilograms of CO2 emissions. The switch to a digital
validation system has not only cut costs associated
with paper, printing, and storage but has also
aligned with Normon’s commitment to environmental
responsibility.

Expansion Plans

Normon continues to broaden its use of the
ValGenesis platform. The company plans to roll out
digital qualification and validation capabilities to
all Plant Technical Services functions, doubling the
number of licenses. As part of this initiative, Normon
intends to leverage the system to draft and approve
URS documents—reinforcing its commitment to
continuous improvement and digital transformation.

There are also plans to integrate the ValGenesis
platform with SAP and TrackWise, further enhancing
data connectivity and operational efficiency.

"We see ValGenesis as a key part of our long-term
strategy, enabling us to continuously improve
efficiency and compliance while adapting to evolving
business and regulatory demands," said José Maria
Torres Rubio, responsible for the Qualifications
Section of Plant Technical Services.

With each expansion phase, the platform strengthens
Normon’s validation framework, increasing efficiency,
improving compliance, and positioning the company
for future growth.

Normon by the Numbers: Validation Excellence at Scale

From laboratory equipment to large-scale manufacturing processes, Normon manages a vast and complex
validation workload. The numbers below highlight the scale of its operations and the critical role the ValGenesis
platform plays in ensuring compliance and efficiency.

• Lab equipment qualifications: 370 pieces of equipment per year
• Computer systems validations: 24 core computer systems, 48 spreadsheets, 44 laboratory equipment
systems, 148 factory equipment systems (SCADA)
• Machine qualification: 440 pieces of equipment classified annually
• Process validations: 220 manufacturing validations and follow-ups on more than 370 batches
• Installation qualifications: 21 qualified manufacturing areas
• Cleaning validations: 157 cleaning validations (101 for orals, 56 for injectables)
• Aseptic filling process validations: 24 aseptic filling process simulations