Our Services

What are your business challenges?

Our services focus on critical business needs as: performance improvement, capability development, and compliant growth.

We can help you!

We customize our services according to your specific needs and goals.

Quality System & Compliance
Proactive Supplier Management
Validation activities
Organization Capability
Human Error

Quality & Compliance

Link quality and business strategy

Our consultancy aims to optimize the efficiency and efficacy of your Quality Management System in compliance with applicable regulatory requirements and, most important, your business needs. We can support you in developing a strategy and action plan to address your processes, procedures, and talent capabilities.

We’re here to help you to:

Sterilization Process Management & Control

Ensure quality while improving operational efficiency.

Providing a customized solution to your purchasing control, including SQM process assessment, supports you to develop an action plan to mitigate risks, improve your system's efficiency, improve your supplier base capability in alignment with applicable regulatory requirements and industry best practices.

We’re here to help you to:

Microbiology

Ensure quality while improving operational efficiency.

We can support you to analyze your labs, process, practices to identify gaps or improvement opportunities in the laboratory, that means to have a traceable and accurate test result. Accordingly, any level of inaccuracy can result in FDS 483's and/or warning letters or worse, the products will not be safe for their intended use.

We're here to help you if:

Proactive Supplier Management

We can help your suppliers meet business needs while being cost-effective.

Providing a customized solution to your purchasing control, including SQM process assessment, supports you to develop an action plan to mitigate risks, improve your system's efficiency, improve your supplier base capability in alignment with applicable regulatory requirements and industry best practices.

We’re here to help you to:

Validation activities​

Do you have more processes to manage with fewer resources?

Lower your burden and boost your operational efficiency.

We’re here to help you to:

e-Validation Software

GO!FIVE™ is a Paperless Validation Software, based in Cloud Computing, with unique features that will optimize time and reduce costs of validation activities. The e-Validation Software is compatible with mobile devices and can also be accessed by computer, with the most used browsers.

Solutions in Validation

• We provide a broad range of reliable and cost-effective services for your validation needs.
• The FIVE Validation services is a reliable and cost-effective solution to your needs in compliance with regulatory agencies such as FDA.
• We also can perform the validation activities remotely with our experienced professionals, our unique software platform (GO!FIVE™), and a completely paperless validation system.

Organization Capability

Improve the value proposition of your Quality Organization

We can help you to deliver against the quality objectives, short-term and long-term business goals through our unique process. The organizational structure and capability assessment consider planned changes, compliance/performance, company strategy, and goals.

We’re here to help you to:

Human Error Reduction

Are you tired of addressing the same human errors in your organization?

We can help you to free-up valuable resources, improve safety, quality, and business performance by reducing human errors. This action learning process will provide a systemic view of human errors, why they occur, their different types, contributing factors, how to investigate them, and guidance towards productive strategies and human error prevention and reduction solutions.

We’re here to help you to:

Let’s connect on a FREE consultation call to see how I can help you.

Contact us

Send me a quick message and I will get back to you in 24 business hours.

Mailing address:
4250 Alafaya Trail,Suite 122 #133, Oviedo
Postal Code: FL 32765
Florida, USA
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