Areas of Expertise:
Computerized System Validation
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Process of generating evidence in a documented way to prove that the system operates according to the use for which it was designed (intended use).
Equipment Qualification
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Process of generating evidence in a documented way to prove that production equipment operates according to the use for which it was designed.
Utility Qualification
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Process of generating evidence in a documented way to prove that the generation, treatment and distribution of water and air are in the quality of production required by the Life Sciences industry.
IT and OT Infrastructure Qualification
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Process of generating evidence in a documented way to prove that the systems that support the Information Technology (IT) and Operational Technology (OT) infrastructure have the capacity to adequately sustain the systems that directly impact the quality and traceability (recording of the entire production process from the beginning to the end ) of the product.
Supplier Qualification
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Process of generating evidence in a documented way to prove the supplier's ability to serve the Life Sciences industry under sanitarian regulatory agencies’ regulations.
Data Integrity
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Application of good practices that aims to ensure accurate information and accurate records of electronic data as well as manuals, essential for the traceability process that encompasses research; preclinical and clinical studies; production; quality control; and distribution of products.
Services
FIVE Defined Scope
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We execute the client’s validation, qualification, or data integrity project from start to finish according to the defined project scope for one or more activities, whether with or without the application of tests by the FIVE Validation team.
There's the option to use the software for digital validation through FIVE Validation's resources at no additional cost.
FIVE Consulting
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Guidance provided to the client's technical team (utilizing their own professional resources for validation and qualification).
Mentorship and participation in strategic validation and qualification meetings.
Furthermore, all documents related to validation and qualification are reviewed according to the client's schedule and audits.
There's the option to use the software for digital validation through FIVE Validation's resources at no additional cost. Mentorias e participações em reuniões estratégicas de validação e qualificação Além disso, todos os documentos envolvendo validação e qualificação são revisados de acordo com o cronograma e auditorias do cliente.
Possibilidade de utilização do software para validação digital pelo recurso da FIVE Validation sem cobrança adicional.
There's the option to use the software for digital validation through FIVE Validation's resources at no additional cost. Mentorias e participações em reuniões estratégicas de validação e qualificação Além disso, todos os documentos envolvendo validação e qualificação são revisados de acordo com o cronograma e auditorias do cliente.
Possibilidade de utilização do software para validação digital pelo recurso da FIVE Validation sem cobrança adicional.
FIVE Assessment
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Customer support for evaluating equipment and/or systems suppliers.
Through this service, it's possible to establish vendor qualification processes and/or conduct audits on potential suppliers.
There's the option to use the software for digital validation through FIVE Validation's resources at no additional cost.
There's the option to use the software for digital validation through FIVE Validation's resources at no additional cost.
FIVE Manager
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Project management for validation, production equipment qualification, factory utility qualification, IT/OT infrastructure qualification, supplier qualification, data integrity, and governance aligned with specific industry standards.
FIVE Audit
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Pre-audit service to assess the validation, qualification, and/or data integrity processes, aimed at reducing non-compliance risks during FDA, EMA, ANVISA, and other regulatory audits. FIVE Validation issues an audit report outlining the audited points and indicating necessary actions if applicable.
There's the option to use the software for digital validation through FIVE Validation's resources at no additional cost.
There's the option to use the software for digital validation through FIVE Validation's resources at no additional cost.
FIVE Academy
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FIVE Validation offers corporate education solutions through videos and personalized online support to reduce non-compliance risks, certify the internal team's competence with regulatory bodies, drive strategic development, and enhance the performance of Life Sciences companies. FIVE also provides the option to conduct these courses 'in-company,' tailoring them to the specific needs of businesses.
Contracting Options:
For any service, here's how they can be acquired.
FIVE Time&Material
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Time and cost are pre-defined, while the scope remains flexible.
We provide estimates regarding the required hours for project execution along with the hourly rate.
Activities are carried out based on FIVE Validation team availability, overseen by a FIVE Validation manager, and reported via agreed-upon periodic reports.
There's flexibility to modify the scope within the same project.
There's also the option to use the software for digital validation through FIVE Validation's resources at no additional cost.
We provide estimates regarding the required hours for project execution along with the hourly rate.
Activities are carried out based on FIVE Validation team availability, overseen by a FIVE Validation manager, and reported via agreed-upon periodic reports.
There's flexibility to modify the scope within the same project.
There's also the option to use the software for digital validation through FIVE Validation's resources at no additional cost.
FIVE Turn-Key
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The time, cost, and scope are predetermined.
Document delivery aligns with the agreed-upon contract and includes oversight by a FIVE Validation manager.
There's an option to request 'without FIVE Validation test execution' (which offers the best cost-effectiveness).
There's also the option to use the software for digital validation through FIVE Validation's resources at no additional cost.
Document delivery aligns with the agreed-upon contract and includes oversight by a FIVE Validation manager.
There's an option to request 'without FIVE Validation test execution' (which offers the best cost-effectiveness).
There's also the option to use the software for digital validation through FIVE Validation's resources at no additional cost.
FIVE Allocation
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The time and cost are pre-established while maintaining flexible scope.
Different from Time & Material, a FIVE Validation professional (resource) is exclusively and recurrently available to the client, overseen by a FIVE Validation manager.
The client has the freedom to define scope with monthly payments.
There's an option to allocate resources on a part-time basis (for example, 50% of the time) for remote activities.
There's also the option to use the software for digital validation through FIVE Validation's resources at no additional cost.
Different from Time & Material, a FIVE Validation professional (resource) is exclusively and recurrently available to the client, overseen by a FIVE Validation manager.
The client has the freedom to define scope with monthly payments.
There's an option to allocate resources on a part-time basis (for example, 50% of the time) for remote activities.
There's also the option to use the software for digital validation through FIVE Validation's resources at no additional cost.
Accelerating Validations by 7x
We have developed our own software to create validation and qualification studies efficiently and standardized, with the best possible cost-benefit.
We are a unique company that offers validation services, in addition to making our software available in the SaaS model. The GO!FIVE® can be used when contracting services without additional costs.
We are a unique company that offers validation services, in addition to making our software available in the SaaS model. The GO!FIVE® can be used when contracting services without additional costs.
Empowering Your Team with Validation Software
The GO!FIVE® software enables deliveries 7 times faster, with a license available for purchase by your company, allowing your own team to perform validations/qualifications autonomously.
Furthermore, save more time, as GO!FIVE® requires no implementation! Start your activities from day one!
Explore the different contracting options available for GO!FIVE® software:
GO!FIVE® Full (unlimited number of validations)
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Customized digital validations at scale, completely flexible through a solution designed for this purpose.
Entire workflows within a single platform, with the ability to extract all documents at any given moment.
With a few clicks, import pre-built validations according to the process and system to be validated. Manage inventories, Validation Master Plans (VMPs), create your private libraries (requirements, risks, and tests), or use our library built on the experience of over 1000 executed projects.
Entire workflows within a single platform, with the ability to extract all documents at any given moment.
With a few clicks, import pre-built validations according to the process and system to be validated. Manage inventories, Validation Master Plans (VMPs), create your private libraries (requirements, risks, and tests), or use our library built on the experience of over 1000 executed projects.
GO!FIVE® to maintain
the validated state
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FIVE Validation can assist in the project and also provide access to GO!FIVE® so that the client can maintain the validated state themselves.
Both projects executed in GO!FIVE® by the FIVE Validation team and those occasionally carried out on paper can be easily maintained in the tool. There's no need to version all items every time there's a new update or change.
Both projects executed in GO!FIVE® by the FIVE Validation team and those occasionally carried out on paper can be easily maintained in the tool. There's no need to version all items every time there's a new update or change.
Here's a comparison of what's included in each contracting option for validation and qualification projects:
Discover the ideal service for each of your needs:
Limited Budget
GO!FIVE®
Service:
FIVE Defined Scope (without running tests)
FIVE Consulting
Emergencies with Projects
Service:
FIVE Defined Scope utilizing GO!FIVE®
Contracting Options:
FIVE Turn-Key
FIVE Time&Material
No Validation Team
Service:
FIVE Defined Scope (with test execution)
Contracting Options:
FIVE Turn-Key
FIVE Time&Material
FIVE Allocation
Search for Knowledge
GO!FIVE®
Service:
FIVE Academy
FIVE Consulting
FIVE Audit
FIVE Assessment
Contracting Options:
FIVE Turn-Key
FIVE Time&Material
Reduced Validation Team
GO!FIVE®
Service:
FIVE Defined Scope (with or without running tests)
Contracting Options:
FIVE Turn-Key
FIVE Allocation
FIVE Time&Material