FIVE Validation · Technology, knowledge and services.

Compliance that protects patients, consumers and your team’s trust.

Simplify validation with technology, team development and specialized services. Manage systems, utilities, equipment, infrastructure, IT/OT, processes, cleaning, analytical methods and much more.

Aligned with leading regulatory agencies:

FDA · ANVISA · MHRA · EMA

Quality and compliance references::

WHO · GxP · ISO 13485 · MDR

The choice of more than 250 life sciences companies:

Pfizer
Takeda
O Boticario
Akebia
Hypera Pharma

Our solutions

Knowledge that delivers results.

We understand your challenges. Because we’ve been by your side more than 2,000 times.

For over 18 years, we’ve put risk-based validation into practice, now reinforced by FDA CSA and the EMA’s revision of EU GMP Annex 11.

Technology

Agile and digital validation with GO!FIVE®

A digital platform to manage the entire validation lifecycle.
  • Get started with anonymized templates that are ready to be adapted.
  • Create private templates tailored to your company’s reality.
  • Benefit from fast adoption and responsive support.
  • More than 70 templates to accelerate your work.
“... the training was personalized, which made it easier to fit around a full-time workload... I was very satisfied with both the content and the way the course was delivered, and I would recommend FIVE Validation to anyone looking for introductory CSV training.”.

Aziz Ali - Eurofins PSS

Team Development

FIVE Academy: Knowledge for those leading the evolution of validation.

  • Learn from experts who work with validation every day.
  • Track your team’s progress and professional development.
  • Build skills in CSV, CSA, GAMP 5®, AI, data integrity and regulatory requirements.
+100 lessons available

Specialized Services

Validation services and strategy

From strategy to execution, with the confidence to make decisions.
  • Plan your validation using a risk-based approach.
  • Execute with experienced professionals and responsive support.
  • Bring Quality, IT and the business together around delivery.
  • CSV / CSA
  • Utilities and equipment qualification
  • IT/OT infrastructure
  • Data integrity
  • Consulting and strategy
“... from kick-off to go-live, I had support, answers and flexibility throughout the project. I recommend FIVE Validation and consider the team a reliable partner.”

Diego Almeida - Torrent

“... a team highly committed to deadlines and project quality... using technology to help speed up delivery and meet deadlines.”

Wilson Marson - Ajinomoto

Your challenge is our starting point

Quality and IT.
One delivery that has to get it right.

The challenge

Why does validation become a bottleneck?


The problem rarely lies where it first appears:


What’s behind it:

01

Validation starts too late.
Important decisions have already been made.

02

Fragmented evidence.
Documents, systems, suppliers and people.

03

Unclear responsibilities.
Quality, IT, the business and suppliers working in silos.

04

Manual work.
Capacity consumed by repetitive tasks.

05

Limited visibility.
Risks emerge only when they start affecting delivery.

The causes lie below the surface.


Efficient validation starts earlier. Connect requirements, risks, responsibilities and traceability from the outset.

Validation that moves delivery forward while ensuring compliance.

Accelerate delivery without compromising compliance. Predictability to deliver. Control to decide. Confidence to move forward.

Who it’s for:

How we simplify validation:

  Trabalho consistente

Reduza trabalho manual e retrabalho. Padronize métodos, evidências e rastreabilidade entre profissionais.

Requirements at the right time

Bring validation requirements into the project early to reduce non-compliance risks and the likelihood of go-live delays.

Visibility to take action

Track status, gaps and responsibilities in real time. Improve predictability across Quality, IT and the business.

Evidence within reach

Centralize evidence and find it faster during audits and inspections.

Proven experience. Measurable results.

Numbers that make an impact

+18

years of experience in validation

+250

companies served

+2000

projects delivered

7X*

Keep up with the pace of the AI era with GO!FIVE®

*Faster compared with manual processes, whether electronic or paper-based.

Clients results

“From months to weeks to prepare.

From weeks to days to review.”

Josiane Touta - Geolab

Awards and certifications that back our track record:

14 Sindusfarma Quality Awards1X CPhI Pharma Awards finalistISO 9001 certifiedISO 27001:2022 certified

Clients

Trusted by more than 250 life sciences companies.

From specialized regional organizations to global companies.

Pfizer
Johnson & Johnson
P&G
Takeda
Galderma
3M
Beiersdorf / Nivea
Ajinomoto
Roche
Alkaloid
Akebia
Belupo
EMS
Hypera Pharma
Geolab
O Boticário
Granado

Those who work in validation know.

More than 120 testimonials. Trust proven.

Experiences from people leading validation in regulated environments.

“... Being paperless and having the documents easy to archive... makes it easier to organize everything for audits.”

Hypopharma

“... GO!FIVE®... a ready-to-use system... the platform automates complex tasks, such as generating the Traceability Matrix... and meets key industry data integrity and validation guidelines (GAMP 5, FDA 21 CFR Part 11 and ANVISA Guide 33/2020).”

Renato Santos — Myralis

“The FIVE team demonstrated exceptional professionalism.”

Markieta Stevem — Galderma

Content & insights

Knowledge that drives change

Knowledge that strengthens your decisions and moves your career forward. Deepen your expertise, anticipate trends and discover new ways to overcome challenges. Practical content for those who want to go beyond compliance and become a trusted reference in their field.

Let's talk?

Why is your validation slow,
costly and complex?

Tell us about your situation. We’ll identify where technology, specialized services or professional development can create the most value.

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    Thaís Cargnin

    We really liked the work that was done, and we are satisfied with the services provided. The customer service and the quality of the work met our expectations. We appreciate the team’s professionalism and commitment.

    Solabia - (10/2026)
    Aziz Ali

    Silvia provided an excellent overview of Computer Systems Validation (CSV). The training was self-paced, making it easy to balance with a full-time workload. Overall, I was very satisfied with both the content and the delivery of the course, and I would recommend Five Validation for anyone seeking introductory training in CSV.

    Eurofins - (10/2026)
    Rafael Mendonça

    The project was carried out with a high level of technical expertise and professionalism. Despite the challenges encountered along the way, the FIVE team maintained transparent communication and delivered a solution that fully meets our needs.

    Fagron - (09/2026)
    Vilma Bernardes

    “Excellent support from consultant Marcelo and his supervisor as well. What stands out most is their ability to understand urgent matters and provide support in moving them forward, being quick and practical throughout the qualification activities. This approach is highly valuable and provides significant support to the business.”

    Ferring - (09/2026)
    Karllos

    “I would like to highlight the agility in responding to tickets opened to clarify questions and resolve bugs, as well as the attention and commitment demonstrated throughout the follow-up with the client. I would also like to emphasize the team’s willingness to listen to and consider feedback and suggestions for improvement, demonstrating openness and partnership in the continuous pursuit of solution improvement.”

    Brainfarma - (09/2026)
    Marcos Gabriel

    “We are still in the early stages of the activities; however, FIVE’s support has been extremely important in helping us define our validation scope. I want to thank the FIVE team for their outstanding support and the quality of their work. They are attentive, knowledgeable, and explain the system very clearly.”

    Brainfarma - (09/2026)
    Diego Almeida

    “I had the opportunity to work with FIVE on a WMS system project. From the kick-off to the go-live, I received support, prompt responses, and flexibility throughout the project. I highly recommend FIVE and consider them a reliable partner.”

    Torrent - (09/2026)
    Deborath Salamonczyk

    “The services provided by FIVE are of the highest quality, and they were a great help to our team during the system validation process.”

    Hebe's - (08/2026)
    Márcio Clementino

    “Services provided with integrity and excellence.”

    Torrent - (08/2026)
    Gabriela Parreira

    “It was a great experience to work in partnership with the FIVE Validation team. Their technical expertise, commitment, and collaboration directly contributed to the project’s success and strengthened the relationship between the teams.”

    Farmax S.A - (07/2026)
    Thaís Soares

    “A well-organized, well-structured project with effective communication.”

    Nortec Química - (07/2026)
    Fernando Noronha

    “FIVE’s partnership on the project helped reduce the system validation time”

    Myralis - (06/2026)
    Deborath Salamonczyk

    I am very satisfied with the services provided.

    Hebe's - (05/2026)
    Markieta Stevens

    The team at FIVE demonstrated exceptional professionalism throughout this project. They were consistently encouraging, supportive, and highly effective in executing the validation activities to the highest standards. I look forward to collaborating with them on future projects. On behalf of the entire Galderma team, we sincerely appreciate FIVE’s guidance, commitment, and support throughout this engagement.

    Galderma - (04/2026)
    Murilo Knop

    “I am very pleased with the quality and speed of service for open tickets in the Go!Five system. This effective and efficient support allows us to pass these qualities on to our operations and deliveries. Keep up the good work!”

    Catarinense - (02/2026)
    Karina Souza

    “I appreciate all the support and professionalism that went into delivering this project, which is so important to the company.”

    Rio Biofarma - (03/2026)
    Markieta Stevens

    “I have enjoyed working with the team at FIVE and I am looking forward to future projects with this team.”

    Galderma - (02/2026)
    Victoria Miranda

    “It is a company that has been validating the Omni system for years and has always delivered high-quality service. “

    Takeda - (02/2026)
    Maja Petinac

    “I can say that GO!FIVE® is a very good solution for the validation process and that it makes work much easier. Almost everything the user needs is available and well structured.”

    Infinus - (01/2026)
    Simone Fernandes

    “We express our satisfaction with the service provided, which fully met our expectations and requirements. We highlight the high technical quality and consistency of the risk analysis conducted throughout the work, demonstrating in-depth regulatory, methodological, and operational knowledge.”

    Bio-Manguinhos - (01/2026)