GO DIGITAL, GO!FIVE®.

We work to minimize the risks of products and services that impact on the health, safety and well-being of families.

VALIDATION

To avoid risks to the patient or consumer, regulatory agencies such as FDA, EMA, ANVISA and WHO,
require that the pharmaceutical, medical products and the entire supply chain industries prepare documents
that prove the proper functioning of processes, systems, and equipment.

WE PROVIDE

INDUSTRIES

Biotech | Pharmaceutical | Medical Devices | Pharma-chemical | Herbal medicines | Medicinal Gases | Sanitizing | Clinical Research | Cosmetic | Personal hygiene | Perfumes | Distribution and storage | Veterinary | Food | Farming | Clinical lab | Calibration lab | Testing lab | Equipment and systems | suppliers of these companies

WHAT

SaaS software for all validation types (paperless) | Computer System Validation | Equipment Qualification | Utilities Qualification | IT/OT Infrastructure Qualification (including cybersecurity items) | Implementation of Integrity and Data | Governance projects | Supplier | Qualification | Project management

HOW

Software paperless GO!FIVE® | Resource allocation | Training and consulting | Turn-key projects (closed scope for the execution of qualifications and validations) | Audit

FIVE Validation carries out validation and qualification projects using GO!FIVE® software 100% paperless.

FIVE client has option (or not) to continue using the paperless model after the project is completed.

The validation documents are delivered in electronic format.

We also provide traditional paper-based services in accordance with the guidelines and procedures of each client.

FIVE IN NUMBERS

6

Quality and/or Innovation Awards*

+1000

Market professionals trained by Five

+15

Years of experience

+1000

Hours of training provided to the market

+190

Companies served

+2000

Hours of training for Five's internal team

+1000

Executed projects

+200

Hours of training that the Five team received abroad

*5 SINDUSFARMA Quality Awards – SINDUSFARMA is the largest pharmaceutical industries association in Brazil, representing more than 90% of the market.

*1 CPhI PHARMA AWARDS SHORTLIST 2022, Category Regulatory Procedures & Compliance – Europe

FIVE HAS THE COMPLETE

SOLUTION IN VALIDATION

Efficient compliance through customer focus with complete validation Solution

Traditionally, validation is documented on paper contained in many folders

ISSUES

  • Burdensome
  • Bureaucratic
  • Subject to failure
  • Slow
  • Onerous

RISKS

  • Stop production
  • Delay product registration
  • Cause fines
  • Product recall
  • Affect the brand image

DIGITAL VALIDATION

GO!FIVE Validation™
Software and consulting services. Contact us today!

Greater Compliance

Streamline compliance with FDA, EMA, ANVISA, WHO.

6x faster

Reduce validation and qualification time by 6x with agile projects.

Lower cost

Avoid rework and lower validation and qualification costs, fully paperless, in the cloud, enabling remote work.

Faster time to market

With no validation, biopharma and medical device industries cannot register or produce their products.

Validate with GO!FIVE®

Get more speed in product time-to-market

THE VALUE

WE GENERATE

Click here to view our testimonial page

Fabiana Toledo

It was the first work experience using the GO!FIVE® tool. I considered it excellent mainly in the aspect of agility and data integrity. Great tool, mainly when teams are allocated to physically separate plants. Hypera Pharma

João Paulo

We have FIVE as a great partner and consultant. I strongly say that FIVE professionals brought a new culture of information security and data integrity to Fagron. Thank you very much. Fagron

Graziela Amaral

There is a great ease in doing business and work with FIVE, due to the high level of understanding and training of collaborators. Ceva

Thais Ushikusa

Seriousness and competence. Bayer

Janine Machado

Excellent job! Galderma

Gabriela Alencar

The work was carried out in an agile and assertive manner. We always had the support of FIVE  during the project. Galderma

Abel Henrique Silva

A company committed and always meeting all the deadlines proposed for the project. Gemini

Luciana Pereira

Very satisfactory, with compliance with the deadlines and specialized team. Gemini

Jair Calixto

FIVE is a serious company and committed to the quality of medicines through the systems validation services provided to the pharmaceutical industries. Refined expertise and a high degree of knowledge in ​​validation. IBBPF

Carina Brolazo

We had all meetings attended and proposals delivered on time. Galderma

Lucas Reinaldi

Very didactic and attentive tutor. Congratulations. Forlogic

Thayana Gimenez

We had positive feedback from many people who attended the webinar. The subject was specific, according to our reality. They dominate the subject a lot! Very good! Forlogic

Mila Palamidovska

The GO!FIVE® platform is easy to use, documents are easily accessed. Alkaloid AD

Darko Atanasoski

The remote validation with FIVE was quite a rewarding experience all together. Alkaloid AD

Nikola Dimovski

The partnership proved to be a complete success. Alkaloid AD

Graziela Amaral

There is a great ease of doing business and working with FIVE, due to the high level of understanding and training of their employees. Ceva

Ricardo Margonato

The FIVE team, besides their great knowledge, is always very committed to the tasks, facilitating the progress of the project. Globe Química

Tatiana Cardozo

I am very grateful to the "FIVE" team for their excellent leadership with the project. FIVE's success is due to the commitment and efficiency of its work. Thank you very much for your help in our many questions and defining courses for actions. BIOMM

Letícia Trova

The FIVE team gave all the necessary support so that the validation happened as planned and within the agreed deadlines. It was an excellent team work. Catalent

Fernanda Ferreira

Once again I would like to thank FIVE for their understanding and professionalism, especially our project colleagues who were extremely assertive and dedicated, contributing a lot to the success of this project! Torrent

Kelly Ido

Working with FIVE on this project was an amazing experience! Ipanema

Adriana Costa

I thank the entire FIVE team for their attention and commitment. The analysts and supervisors are wonderful professionals. Fundação Bahiafarma

Everton Donel

I would like to congratulate the FIVE team for being extremely professional. Pfizer

Augusto Mendonça

FIVE's team is to be congratulated for the guidance and support with our computerized system validation project, the use of the GO!FIVE® platform also helped a lot in the success of this project. Laboratório Wesp

Ricardo Margonato

This project ran effortlessly and the FIVE team was always available to help. This type of project was, by its idiosyncracies and complexity, a real drain of time, so a realistic, well-managed and well-trained team, along with the programming are just some of the reasons for our success. The GO!FIVE® platform helped to give speed and confidence. Globe Química

Rodrigo Endo

Efficient and assertive, excellent! The portal of GO!FIVE® is very good, congratulations! Great validation analysts and we must congratulate the management. Toledo / P&G

Lais Yamamoto

We had an urgent project with a short deadline and the FIVE team met our needs and delivered all the requirements on time with the desired quality. Thanks for your partnership. Thank you very much! Galderma

Fernanda Ferreira

The realization of the project by the FIVE team was of extreme dedication and cooperation. On behalf of Torrent, I would like to thank all the specialists for their professionalism, and being efficient! The GO!FIVE® system is intuitive and was of great value. We are very happy to have finished this journey with FIVE, and hope that soon we will be together for other successful projects in the future. Torrent

Leni Carvalho

Congratulations, very helpful staff. BIOMM

Rubens Fernandes

One of the most important challenges in any computer system validation project is the control and management of the documents captured in the project, as well as the generation of documents and their mandatory approvals. In the RBBL project, with the use of the GO!FIVE® platform from FIVE Validation, this challenge is no longer a problem. The platform properly managed all the documents and their versions, as well as all the required approvals at each stage of the project. We used the GO!FIVE® platform during 9 months of our project, without the occurrence of any systemic bug. EMS

Ingrid Oliveira

It was a very valuable training for me, especially in the automation part, which I didn't know much about. Fresenius Kabi

Lucas Rodrigues

Excellent training, very didactic and interactive. Being conducted onsite facilitated the interaction and learning a lot. Fresenius Kabi

Tatiana Cardozo

The FIVE employees' expertise, who were involved in the project, especially the system to be validated and the validation concepts, helped BIOMM to carry out the project effortlessly. BIOMM

Ellen Costa

It was a challenging and very difficult project for the company, Five's support and critical vision were essential for this project's success. HalexIstar

Graziela Amaral

The entire project was well-organized in all its facets, meeting all of Ceva's needs. The conducting of the validation activities occurred pro-actively, objectively and quickly, both in the aspects of interpersonal relationships and the technical discussions to resolve problems encountered during the project. The whole process of documentation was logical. Review and execution with GO!FIVE® was very easy to do. Ceva

Isabella Azevedo

This project was my first experience with FIVE, and I have nothing but praise for them. I was given the project in the middle of the process and the people at FIVE gave me all the support that I needed to understand the stage where our group was at, and were very patient in showing me how to execute the tasks in the application. I thank FIVE for all their commitment and dedication. Thank you so much! Catalent

Cristiane Vargas

We were always very well treated during the meetings and during the execution phase of the project. Those responsible demonstrated total mastery of the subject and competence. Congratulations to the team! Espírito Santo Distribuidora

Carlos Junior

Very satisfied. Prati Donaduzzi

Sibeli Soares

Simply efficient Catalent

Vinicius Neugebauer

I think the system is nice and easy to use from the point of view of those who go into it to approve documentations. Takeda

Luciana Gonçalves

It was our first experience with external validation and it was great; very easy and well organized. Laboratório Wesp

Breno Gine

Very productive contents. Ibramed

Juliano Oliveira

Very valuable content. Ibramed

Vinicius Neugebauer

The process change of document elaboration, items discussion and tests execution was more efficient, because the strategy was to follow the matrix lines, speeding up the validation process and activities management, while working on improvements in parallel. The work of the validation professionals was exceptional. Takeda

Gabriela Sanches

I chose FIVE due to the good reputation in the market and due to previous participation in trainings that were very well conducted. Boehringer Ingelheim

Felipe Almeida

I was attended to by a great professional who explained very clearly and patiently the whole process to our team. Pharmalog

Diego Araujo

I was very well attended to and had great support. Pharmalog

Rafael Moraes

The technical knowledge of the FIVE team and FIVE's exclusive management tools enable the validation of computerized systems to be conducted safely and systematically. Eckert & Ziegler

Maurício Barth

First-rate team! The GO!FIVE® platform is a very good tool for System Validation. Prati Donaduzzi

Tiago Conceição

Working with GO!FIVE® was a great experience; it significantly streamlined the 'bureaucratic' documentation processes, and its traceability features were very beneficial. Prati Donaduzzi

Cassiana Mazzer

I would like to thank the FIVE team very much for all the care they had in this project. You were truly exceptional in meeting deadlines, attention, patience, planning, among other aspects. Solabia

Lais Yamamoto

Thanks for your partnership. Galderma

Rodrigo Endo

Great job. Toledo / P&G

Gerusa da Silva Lopes

I emphasize the dedication of the professionals involved in the project, including their professionalism and willingness to answer questions and propose solutions. Porto Seco Centro Oeste

Rafaella Nascimento

In general, this project was very good, FIVE's team provided all necessary assistance during the project. They clarified all questions and provided several alternatives during the discussion, helping us to solve our problems. Cargill

Cristiane Vargas

We were always very well-handled by FIVE consultants. They were very helpful in assisting us with our project and questions. Espírito Santo Distribuidora

Priscila Gouveia

An easily accessible system for both approving evidence and navigating O Boticario

Gabriela Theis

Really interesting software! FGM Dentalgroup

Evangelos Mantadakis

Great presentation! Great overview! Cannavigia

Polyana Marçal

The use of GO!FIVE®, as well as the libraries provided in the system, has resulted in a significant improvement in the efficiency of generating subject-specific documents and simplification of review and approval routines. Our expectation is to manage all validations in the software, as well as maintenance and periodic reviews in the future Hypofarma

Camila Joaquim

Great commitment from the team in delivering the project, along with excellent interpersonal relationships Prati Donaduzzi

Vanessa Scaldelai

A team that assisted us was very helpful Stryker

Thalyta Almeida

The whole team is very friendly and helpful. They also have great technical expertise Ortofarma

EXCLUSIVE

CONTENT

GAMP5® 2nd edition and CSA FDA: Why they can be good for business.

Some important points that the second edition of GAMP5® and CSA bring and make us think about ‘how system validations will be from now on.

Read more

Cloud Computing Validation in a Regulated Environment

Cloud Computing plays an essential role in the digital revolution that most companies are now experiencing.

Read more

System Validation leaves paper behind, projecting us into the digital era.

Probably we still validate using paper because we are used to it because it is the only way we know how to do it or because most companies still do so.

Read more

LEARN MORE ABOUT

OUR PROGRAMS

Be our Sales Rep!

If your company works for corporate clients in the Life Sciences area, already has contacts with this market to sell products or services, and understands that validation can add value to your business; maybe your company is just the one we’re looking for to be our sales rep!

Partner Client

Is your company seeking innovation and quality in the provision of its services?

FIVE Validation offers a special condition that enables our Partner clients to monetize considerably.

GO!Startup Program

A complete package that gives you access to software, training, support, and consulting hours to meet your FDA, EMA, and WHO validation compliance requirements: 6x faster.
Save 75% of time and money while increasing compliance.