Our Most Successful Projects

What makes our projects achieve extraordinary results?

At FIVE Validation, we are global specialists in validation for the Life Sciences industry. We deliver high-impact projects with technical excellence, continuous innovation, and total regulatory compliance.

We combine deep sector knowledge and focus on digital transformation, information security, and sustainable practices to ensure solutions that generate real value, reduce risks, and accelerate the success of our clients.

Validation without complication, wherever and whenever you need it

We offer a complete solution that combines experienced professionals and advanced digital platform to accelerate validation projects anywhere in the world. This solution is ideal for companies that do not have a validation team, have reduced teams, face budget constraints, need to meet challenging deadlines, or simply want to go digital and agile.

With our support, the lack of specialists or resources will not be an obstacle to the success of your projects.

 

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+17

Years of experience

+230

Clients

+1000

Executed projects

85%

Reduction of validation effort

Explore some of the projects delivered by FIVE Validation

 

IT Solutions and Digital Transformation

  • Artificial Intelligence – AI / Machine Learning - ML
  • ERPs like SAP®, Protheus®, Dynamics®, among others.
  • Warehouse Management – WMS
  • IT and OT Infrastructure Qualification
  • Master data management
See more:
• Custom applications
• Automated workflows platform
• Digital validation
• Purchasing management
• Spreadsheets
• Electronic Batch Record – EBR
• Label management system
• Metrology management system
• MES - Manufacturing Execution System
• Enterprise Content Management – ECM
• Maintenance management system
• Clinical data management and clinical research
• Weighing and dispensing
• Traceability
• Stability management system
• Calibration management system
• Sample control
• Statistical analysis
• Method validation platform
• Order picking
• Environmental management – EHSM
• Extended Warehouse Management – EWM
• Transportation management – TMS
• Content management – KMS
• Governance, risk, and compliance – GRC
• Access control

Quality and Compliance System

  • Training management - LMS
  • Electronic Document Management – eDMS
  • Non-conformity, deviation, and CAPA management (part of QMS)
  • Audit management (part of QMS)
  • Change management (part of QMS)
See more:
• Quality management (part of QMS)
• Indicator management (part of QMS)
• Risk management (part of QMS)
• Customer Service – call center and pharmacovigilance (complaints)
• Supplier management system
• Regulatory affairs management system

Automation Systems / Automated Equipment

  • Autoclaves
  • Blow Fill Seal - BFS (IV infusion bags - polymers)
  • Building Management System – BMS/HVAC
  • Door interlocking system
  • EtO Sterilization Chamber
See more:
• Cold and stability chambers
• Vision chambers
• Checkweigher
• Chillers
• Coders
• Labelers
• Compactors
• Distillers
• Blistering machines
• Fillers
• Conveyors control
• Form Fill Seal - FFS (IV infusion bags - film)
• Ampoule and bottle washers
• Fluidized bed
• Lyophilizers
• Mixers
• Environmental monitoring system
• Purified water generation and distribution system (PW)
• Water for injection generation and distribution system (WFI)
• Pure steam (PS)
• Liquid and semi-solid reactor
• Temperature recorders for equipment qualification
• Dryer
• Automation systems - PLCs, HMIs, supervisory systems
• Clean In Place - CIP
• Sterilization In Place - SIP
• Depyrogenation tunnel
• Palletizing system

Laboratories and
Quality Control

  • Endotoxin analyzer
  • Particle analyzer
  • Colony counter
  • Colorimeter
  • Microorganism detector
See more:
• Dissolution tester
• Spectrophotometer
• Mass spectrometer
• Laboratory Information System - LIMS
• Microplate reader
• Raman - portable spectrophotometer
• CDS: HPLC, GC, UPLC management systems such as OpenLab (Agilent), LabSolutions (Shimadzu), and Empower (Waters), among others.
• UV-Vis
• Karl Fischer titrators and others
• Test report management system
• TOC - Total Organic Carbon
• Potentiometer
• pH meter
• Viscometer
• Test system – traction and compression

The benefits of hiring the FIVE team

  • In-house team with broad validation knowledge across different areas.
  • FIVE shares knowledge with the client throughout the validation project.
  • The team knows the GO!FIVE® tool well and uses it for fast, digital validation.
  • GO!FIVE® includes ready-to-use content that speeds up work and keeps validation solid.
  • Projects can be done in phases, following Agile methods.
  • A manager reviews the work to catch issues early, avoid rework, and improve quality.
  • Multiple team members are involved and informed, so the project runs smoothly even if something unexpected happens.

 Get a free consultation with the FIVE Validation team for personalized guidance.

Check more information on the registration page;

What the market says about us

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    "I have enjoyed working with the team at FIVE and I am looking forward to future projects with this team."
    Markieta Stevens
    Galderma - (02/2026)
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    "It is a company that has been validating the Omni system for years and has always delivered high-quality service. "
    Victoria Miranda
    Takeda - (02/2026)
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    "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."
    Maja Petinac
    Infinus - (01/2026)
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    "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."
    Simone Fernandes
    Bio-Manguinhos - (01/2026)
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    "FIVE was essential in enabling us to conduct this validation satisfactorily. I would like to congratulate the team for their organization, clarity in the steps, and willingness to assist us with any questions we had. Without a doubt, it was a time of great exchange and learning, and I would recommend FIVE to any laboratory wishing to implement and validate a new system."
    Mayara Sá
    Bio-Manguinhos - (01/2026)
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    "The project was completed successfully and with commitment."
    Jéssica Alves
    Solabia - (12/2025)
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    "Excellence in service provided"
    Eliane Aguiar
    Takeda - (12/2025)
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    "Excellent work by FIVE, all the support provided was sensational! Everyone involved was patient, available, helpful, and objective. They clarified all doubts and suggested possibilities, always with justification and high-level technical knowledge."
    Fernando Alves
    Besins Healthcare - (12/2025)
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    FIVE presented a solid technical foundation, resulting in a robust and safe project.
    Helda Machado
    Fagron - (11/2025)
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    The project was handled very well by Fagron's validation team. We have always relied on FIVE's expertize for our projects, which is why Fagron has been a FIVE partner for over 8 years. Here's to the next projects!
    João Mendes
    Fagron - (11/2025)
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    I only took part in the project for a short time, in the final stages of the reports, but I was satisfied with the support provided and the guidance given. Meetings were agile and clear about the objective.
    Paôla Oliveira
    ADCOS - (09/2025)
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    Exceptional service.
    Luana Lemes
    R2PHARMA - (09/2025)
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    The project was delivered with quality, as expected, and the team's service was always agile and helpful, promptly assisting with any doubts or problems. We were very satisfied with the partnership.
    Agnes Morgana Gomes Candido
    Farmarin - 08/2025
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    I would like to express my special thanks to FIVE team for all the exchanges of experience and the challenges shared throughout this validation, which enabled us to finalize and prepare a consistent and well-structured document.
    Murillo Henrique Araujo Eloy
    Farmarin - 08/2025
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    I liked the service provided, it was satisfactory and inclusive.
    Bruno Dias Camargo
    IBMP - 08/2025
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    FIVE employees have always been willing to do their work in the best possible way. I would like to thank FIVE team for their services.
    Pedro Miguel Cabrera Ruschel
    R2Pharma - (08/2025)
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    The project was a success, with FIVE providing all the support and guidance necessary to ensure the quality of the project.
    Sara Rhaissa Rezende dos Reis
    R2Pharma - (07/2025)
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    My thanks to those involved in the project for their availability and support in resolving doubts along the way.
    Maurício Dias
    Logic - (07/2025)
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    FIVE contributed a great deal to bringing this project to a successful conclusion. I would especially like to thank Luana for her patience and dedication.
    Tatiana Cardozo
    BIOMM - (06/2025)
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    Great cooperation with FIVE Validation despite the fact that we were sometimes intrusive with our requests and often asked FIVE Validation to execute some of our requests extremely quickly.
    Sanda Bozicevic
    Belupo - (05/2025)
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    Another excellent job
    Giovana Cesar
    EMS - (05/2025)
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    Browser in GO!FIVE was arranged very good so that each user could very quickly find solution and way to solve his task. Each additional question was resolved in very short time and that is very important in this kind of projects.
    Ana Vlah
    Belupo - (04/2025)
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    Appreciation for great cooperation, prompt responses, and timely communication.
    Jasenka Balić-Hajro
    FARMAVITA d.o.o - (04/2025)
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    Appreciation for great collaboration, prompt responses, and timely communication.
    Suzana Golenja
    FARMAVITA d.o.o - (04/2025)
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    Eu, Suzana Golenja, agradeço a grande colaboração, as respostas rápidas e a comunicação oportuna.
    Hakija Ćidić
    FARMAVITA d.o.o - (04/2025)
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    It was my first project with FIVE. It was a great experience. An exchange of knowledge and a good partnership.
    Giovana Cesar
    EMS - (03/2025)
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    Without comment, EMS was very well supported by FIVE.
    Paulo Machado
    EMS - (03/2025)
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    Good presentation, dynamic on the subject raised, with clear and objective answers on the content.
    Mauricio Sousa
    Geolab - (03/2025)
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    FIVE specialist has always been very prompt with her deliveries
    Victoria Miranda
    Takeda - (02/2025)
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    The quality of the services provided by FIVE was excellent, deadlines were met and the necessary support was provided. The professionals demonstrated in-depth knowledge of validation processes and helped us through a number of challenging scenarios.
    Eliane Aguiar
    Takeda - (02/2025)
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    Very rich training and complements theoretical information with practical experiences of system validation.
    Victor Santos
    Geolab - (02/2025)
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    I'd like to thank you for the excellent validation service. The quality, commitment and attention to detail were fundamental to the success of the project. I'm grateful for the relocation of activities, which allowed us to complete allstages. Dedication and flexibility were essential for us to achieve the result. Congratulations on your professionalism!
    Edilaine Ferreira
    Rio Biofarma - (02/2025)
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    There is peace of mind in knowing that we are not in the hands of a professional, but of a company that provides us with a quality validation service and, if necessary, will help us to resolve any problems that may arise, such as delays in deliveries, professionals leaving and many other issues that we face when carrying out a project.
    Jozie de Souza
    Organon - (12/2024)
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    I would like to thank FIVE for a job well done at Galderma US to develop the CSV documentation. It was a pleasure to work with the team. The project team was available for any questions we had, and the documentation was completed within the agreed timeframe. We look forward to continued collaboration between Galderma US and FIVE.
    Markieta Stevens
    Galderma - (01/2025)
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    Everyone was always very helpful and provided solutions for the smooth running of the project.
    Vivian Velloso Hernandez
    Takeda - (10/2024)
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    Excellent support and response time, along with expertise in processes that help us maintain the quality of the service provided to our clients.
    Natália da Silva
    Voxline - (08/2024)
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    Overall, the FIVE team showed great commitment to the project and was a valuable partner in solving the challenges encountered. It has been a pleasure working with you during this time.
    Ana Ulbrich
    Megalabs - (07/2024)
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    FIVE has a team highly committed to project deadlines and quality.
    Wilson Marson
    Ajinomoto - (07/2024)
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    The validation service provided by the contracted company was a learning experience for us at Ajinomoto, exceeding our expectations in every aspect and contributing to our learning. The team demonstrated technical knowledge, commitment, and efficiency throughout the entire process. We are pleased with the results achieved and recommend your services without hesitation.
    Fabiana Gaspar
    Ajinomoto - (07/2024)
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    A company highly committed to delivering a validation package with a high level of excellence, sometimes even exceeding our validation vision, using technological resources as support to expedite deliveries promptly.
    Wilson Marson
    Ajinomoto - (07/2024)
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    I deeply appreciate the entire team for the quality in delivering the entire validation package and for meeting the deadlines of our challenging schedule. Congratulations on the work and tools used. It was a pleasure working with you!
    Daiane Moreira
    Ajinomoto - (07/2024)
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    Excellent work and validation completed in a short time.
    Luiz Zacharias
    Ajinomoto - (07/2024)
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    I appreciate the support and dedication of FIVE Validation to help us successfully complete this project!
    Leonardo Schneider
    Ajinomoto - (07/2024)
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    I want to use this opportunity to thank FIVE and to praise your work on Belupo validation project so far. I understand that FIVE validation is a good partner for Belupo and that the team is really quick and fast in providing the service. Special thanks to the validation analyst with who we have a great collaboration and communication.
    Heđever Tihomir
    Belupo - (06/2024)
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    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.
    Fabiana Toledo
    Hypera Pharma - (04/2020)
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    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!
    Thayna Gimenez
    Forlogic - (09/2019)
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    A company committed and always meeting all the deadlines proposed for the project.
    Abel Silva
    Gemini - (05/2020)
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    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.
    Jair Calixto
    IBBPF - (03/2019)
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    There is a great ease of doing business and working with FIVE, due to the high level of understanding and training of their employees.
    Graziela Amaral
    Ceva - (02/2020)
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    The FIVE team, besides their great knowledge, is always very committed to the tasks, facilitating the progress of the project.
    Ricardo Margonato
    Globe Química - (01/2022)
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    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.
    Tatiana Cardozo
    BIOMM - (01/2022)
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    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.
    Letícia Trova
    Catalent - (03/2023)
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    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!
    Fernanda Ferreira
    Torrent - (04/2022)
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    I thank the entire FIVE team for their attention and commitment. The analysts and supervisors are wonderful professionals.
    Adriana Costa
    Fundação Bahiafarma - (06/2022)
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    I would like to congratulate the FIVE team for being extremely professional.
    Everton Donel
    Pfizer - (08/2022)
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    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.
    Ricardo Margonato
    Globe Química - (01/2022)
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    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.
    Fernanda Ferreira
    Torrent - (03/2022)
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    Congratulations, very helpful staff.
    Leni Carvalho
    BIOMM - (09/2022)
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    It was a very valuable training for me, especially in the automation part, which I didn't know much about.
    Ingrid Oliveira
    Fresenius Kabi - (12/2022)
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    Excellent training, very didactic and interactive. Being conducted onsite facilitated the interaction and learning a lot.
    Lucas Rodrigues
    Fresenius Kabi - (12/2022)
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    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.
    Tatiana Cardozo
    BIOMM - (12/2022)
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    It was a challenging and very difficult project for the company, Five's support and critical vision were essential for this project's success.
    Ellen Costa
    HalexIstar - (12/2022)
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    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.
    Graziela Amaral
    Ceva - (11/2022)
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    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!
    Isabella Azevedo
    Catalent - (11/2022)
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    Very satisfied.
    Carlo Junior
    Prati Donaduzzi - (12/2022)
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    Simply efficient
    Sibeli Soares
    Catalent - (03/2023)
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    I think the system is nice and easy to use from the point of view of those who go into it to approve documentations.
    Vinicius Neugebauer
    Takeda - (03/2023)
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    Very productive contents.
    Breno Gine
    Ibramed - (05/2023)
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    Very valuable content.
    Juliano Oliveira
    Ibramed - (05/2023)
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    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.
    Vinicius Neugebauer
    Takeda - (03/2023)
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    "Project carried out excellently, always in touch and taking into consideration the scores given by Hypofarma."
    Polyana Oliveira
    Hypofarma - (05/2024)
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    "Just grateful to the FIVE team for their support and dedication to our project."
    Tatiane Gonçalves
    Farmax - (05/2024)
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    "Extremely organized work, what was agreed upon was provided."
    Rafael Lima
    LM Farma - (01/2020)
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    "We carried out a high-impact project in partnership with FIVE, which, through the use of the GO!FIVE® software in the execution of qualification and validation tests, provided us with a 20% reduction in workload allocated to these activities, as well as saving one month of work from various teams while meeting internal quality standards."
    Victor Rodrigues
    Organon - (05/2023)
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    "Great professionals, have a broad validation knowledge, produce excellent documents, have initiative and take the right decisions when needed, and help the rest of the team above what should be expected from them. Happy to work with FIVE!"
    Estanis Ferrater
    BeiGene - (03/2024)
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    The whole team is very friendly and helpful. They also have great technical expertise
    Thalyta Almeida
    Ortofarma - (02/2024)
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    A team that assisted us was very helpful
    Vanessa Scaldelai
    Stryker - (01/2024)
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    Great commitment from the team in delivering the project, along with excellent interpersonal relationships
    Camila Joaquim
    Prati Donaduzzi - (12/2023)
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    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
    Polyana Marçal
    Hypofarma - (12/2023)
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    Great presentation! Great overview!
    Evangelos Mantadakis
    Cannavigia - (09/2023)
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    Really interesting software!
    Gabriela Theis
    FGM Dentalgroup - (09/2023)
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    An easily accessible system for both approving evidence and navigating
    Priscila Gouveia
    O Boticario - (09/2023)
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    We were always very well-handled by FIVE consultants. They were very helpful in assisting us with our project and questions.
    Cristiane Vargas
    Espírito Santo Distribuidora - (06/2023)
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    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.
    Rafaella Nascimento
    Cargill - (06/2023)
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    I emphasize the dedication of the professionals involved in the project, including their professionalism and willingness to answer questions and propose solutions.
    Gerusa da Silva Lopes
    Porto Seco Centro Oeste - (06/2023)
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    Great job.
    Rodrigo Endo
    Toledo / P&G - (06/2023)
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    Thanks for your partnership.
    Lais Yamamoto
    Galderma - (10/2022)
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    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.
    João Paulo
    Fagron - (02/2019)
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    Very didactic and attentive tutor. Congratulations.
    Lucas Reinaldi
    Forlogic - (02/2020)
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    We had all meetings attended and proposals delivered on time.
    Carina Brolazo
    Galderma - (12/2019)
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    The work was carried out in an agile and assertive manner. We always had the support of FIVE  during the project.
    Gabriela Alencar
    Galderma - (10/2019)
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    Excellent job!
    Janine Machado
    Galderma - (10/2019)
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    Seriousness and competence.
    Thais Ushikusa
    Bayer - (07/2019)
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    Very satisfactory, with compliance with the deadlines and specialized team.
    Luciana Pereira
    Gemini - (05/2020)
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    Working with FIVE on this project was an amazing experience!
    Kelly Ido
    Ipanema - (05/2022)
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    Efficient and assertive, excellent! The portal of GO!FIVE® is very good, congratulations! Great validation analysts and we must congratulate the management.
    Rodrigo Endo
    Toledo / P&G - (03/2022)
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    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!
    Lais Yamamoto
    Galderma - (03/2022)
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    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.
    Augusto Mendonça
    Laboratório Wesp - (09/2022)
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    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!
    Cristiane Vargas
    Espírito Santo Distribuidora - (11/2022)
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    It was our first experience with external validation and it was great; very easy and well organized.
    Luciana Gonçalves
    Laboratório Wesp - (03/2023)
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    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.
    Cassiana Mazzer
    Solabia - (11/2023)
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    Working with GO!FIVE® was a great experience; it significantly streamlined the 'bureaucratic' documentation processes, and its traceability features were very beneficial.
    Tiago Conceição
    Prati Donaduzzi - (11/2023)
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    First-rate team! The GO!FIVE® platform is a very good tool for System Validation.
    Maurício Barth
    Prati Donaduzzi - (11/2023)
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    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.
    Rafael Moraes
    Eckert & Ziegler - (10/2023)
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    I was very well attended to and had great support.
    Diego Araujo
    Pharmalog - (07/2023)
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    I was attended to by a great professional who explained very clearly and patiently the whole process to our team.
    Felipe Almeida
    Pharmalog - (07/2023)
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    I chose FIVE due to the good reputation in the market and due to previous participation in trainings that were very well conducted.
    Gabriela Sanches
    Boehringer Ingelheim - (07/2023)
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    The control, management, generation, and mandatory approval of documents are significant challenges during the validation process. GO!FIVE® prevented this from becoming an issue in the RBBL project due to proper management and approval of document versions. Throughout the 9 months of the project, there were no systemic bugs.
    Rubens Fernandes
    EMS - (11/2022)
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    The partnership proved to be a complete success.
    Nikola Dimovski
    Alkaloid AD - (11/2022)
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    The remote validation with FIVE was quite a rewarding experience all together.
    Darko Atanasoski
    Alkaloid AD - (11/2022)
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    The GO!FIVE® platform is easy to use, documents are easily accessed.
    Mila Palamidovska
    Alkaloid AD - (11/2022)
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