GO!FIVE

Validation in the digital age for pharmaceutical and medical industries
Published by Five Validation

Overview

Validation in the digital age, 3x faster

Validation: To avoid risks to the patient or consumer, regulatory agencies such as FDA, EMA, and WHO, require that the pharmaceutical, medical products, and the entire supply chain industries prepare documents that prove the proper functioning of processes, systems, and equipment.


Traditionally, validation is documented on paper contained in many folders and is burdensome, bureaucratic, subject to failure, slow and onerous. Some of the risks are stopped production, delayed product registration, and product fines which recall and affect the brand image.


To solve this problem, we created GO!FIVE, a scalable SaaS platform, where it is possible to validate 3x faster following agile methodology. It has 10+ years of consulting within the software as pre-ready validations built into it. The review and approval of electronic workflow allow remote validations the most times.

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GO!FIVE

Benefits

Save time and increase compliance.
GED Vs GO!FIVE: GED is a platform used to manage the review and approval of documents in a Validation project. GED users are forced to prepare the documentation manually, which increases the risk of nonconformity in the project by not providing the means to create documentation within the platform. By eliminating critical data manual management, GO! FIVE drastically reduces the danger of non-compliance, as well as being designed to allow not only management, but the preparation of documents with greater agility and safety, from the beginning of the project until the Final Validation Report.
Greater agility with Parallel Flow and Validation by Items.

GO!FIVE eliminates the need to complete the review and approval of an entire document, only to start the next one. It is also possible to create packages of items of the same type and send them for review and approval in a Parallel Flow, when the system sends the package items to all those responsible at the same time, and in the Serial Flow, when the items become available for analysis of one Analyst at a time. These are dedicated features to reduce document review and approval time and, consequently, reduce the time to issue Validation Reports.

Greater Compliance with digital data management
The data generated in GO!FIVE is stored on a cloud server, with international certifications, which confirm the commitment to high levels of security, confidentiality and service availability. It is also possible to define roles for users and limit access according to project responsibility and expand platform capacity to accommodate simultaneous, large-scale access without instability.

Product Attributes

Solutions for
Schneider Electric Certification
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