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:
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 GO!FIVE® system is good and easy to use from the perspective of someone who logs in to approve documentation.”.
“The fact that GO!FIVE® is already validated and offered as SaaS, along with the fast support, is a plus. The content libraries are also a key differentiator.”.
“... there is much more value being delivered... the support team and customer follow-up are exceptional...”.

“... 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.”.
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.
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.”
“... a team highly committed to deadlines and project quality... using technology to help speed up delivery and meet deadlines.”
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:
Go-live under pressure
Deadlines at risk.
Rework and unpredictability
Wasted time and resources.
Audit pressure
Evidence that is hard to find and defend.
What’s behind it:
01
02
03
04
05
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:
For leaders
Demonstrate control, efficiency and compliance.
With GO!FIVE®, show senior management the progress of validation, responsibilities and evidence behind your team’s results. Strengthen your credibility and professional reputation. Get recognized for your leadership and results, opening up opportunities for career growth and promotion.
For operations
Deliver on time. Maintain compliance.
Accelerate delivery without sacrificing compliance, and gain confidence in meeting the agreed go-live date and facing audits and inspections. Fewer surprises and less regulatory risk; more clarity and control.
For the team
Collaborate better. Demonstrate results.
Strengthen collaboration between Quality and IT and make successful delivery visible to senior management.
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
years of experience in validation
companies served
projects delivered
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:
Clients
Trusted by more than 250 life sciences companies.
From specialized regional organizations to global companies.
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.”
“... 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).”
“The FIVE team demonstrated exceptional professionalism.”
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.
Secure Data Sharing Between Units: Best Practices in Regulated Environments
In many Life Sciences organizations, sharing data between business units, manufacturing sites, or legal entities is essential for operational efficiency and regulatory reporting.
Read the article
Risk-Based Validation: The Shift Has Begun. Is Your Organization Ready?
What if the greatest risk in computerized system validation is not doing too little, but spending too much effort on the wrong things?
Read the article
Why Are Global Sponsors Looking at Brazil Differently?
Brazil is bringing together an increasingly relevant combination for global clinical research: scientific expertise, population diversity, operational competitiveness, and an evolving regulatory environment.
Read the articleLet'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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