About FIVE

 

Five has a highly qualified and experienced staff of pharmaceutical, engineering and technology areas. The team is leaded by the engineers Silvia Martins e João Gomes. Five provides services Computer System Validation, Equipment and Utilities Validation, Infrastructure Qualification, Data Integrity and Data Governance as outsourcings (allocation), audits, consultancies, training, supplier assessment, turn-key documents preparation and project management. The focus is align the production systems of the clients with the demands and requirements of major regulatory agencies in the world, such as FDA, EMA and WHO.
Five is flexible to serve the clients in turn-key projects or time material format.
Five provides is efficient carrying out the activities because it uses Software GO!FIVE® – Validation Lifecycle Management System and serve it as SaaS model.

 
About Five
1

Flexibility

Proposal of working models that best fit the needs of each company. FIVE is open to different working formats.
About Five
2

Team Work

FIVE works with their own team making it easier to solve project issues that are risk-based. It operates with supervision to define validation strategies and documents review.
About Five
3

Quality

FIVE's quality policy is based on the updated versions of ISO 9001:2015, seeking customer satisfaction and improvement of FIVE processes
About Five
4

Conformity

Compliance with legal requirements, regulations and guidelines of the main regulatory worldwide agencies, such as FDA, EMA, WHO, etc., guides such as GAMP5® and the procedures of each company.
About Five
5

Specialty

FIVE works exclusively in the areas of its Expertise, seeking alignment with the life science Global market and knowledge updating.

GAMP5® is a guide that has its intellectual rights reserved by ISPE™. Available for purchase at ispe.org