GO!FIVE® - Validation Lifecycle Management System
Paperless Systems Validation Platform, cloud-based, for computers, notebooks and/or mobile devices, such as tablets. GO!FIVE® is responsive, runs on the most commonly used browsers and complies with FDA 21 CFR Part 11, GAMP5® and ANVISA requirements. READ MORE
In this modality, the client can hire FIVE for a pre-audit, reducing risk in audits by the FDA and other regulatory agencies. FIVE issues an Audit Report that includes the audited points, indicating the actions to be taken, if applicable.
FIVE supports its customers in the evaluation of their equipment and/or systems suppliers. FIVE provides services for the definition of vendors and/or on-site audit qualification process of potential suppliers. A basic service to be performed, mainly in case of acquisition of equipment and/or systems partially or totally customized for the client's process.
FIVE offers training and lectures on-site or in our offices, tailored specifically to each company in all the subjects which FIVE is a specialist on. With the objective of consolidating the theoretical and practical concepts of Validation, Qualification and Data Integrity. FIVE organizes the guidelines of its events respecting the specificity and necessity of each client.
FIVE guides the internal Technical team of the client, who then uses his own professional resources to work in the areas of Validation and Qualification. Working in person and remotely, with regularly scheduled visits and meetings. We can host team trainings including orientations in work model definition with editable templates and procedures. All Validation and Qualification documents are reviewed following the customers’ needs, schedules, and audits. FIVE document models are robust and consolidated, bringing regulatory security to the production process.
FIVE manages validation and qualification projects aligned with the specific standards of the regulations and laws of the region. Regardless of the size of your project, FIVE can plan and monitor team's activities in order to achieve the expected results, ensuring the delivery of the implementation project or equipment and system installation in compliance with regulatory requirements.
Closed project or turn-key models. The client contracts FIVE to prepare one or more previously specified documents. FIVE acts in the validation and qualification life cycle, preparing to provide all the documents foreseen in the GAMP5® (Good Automated Manufacturing Practice guideline), including the application of tests in all phases. There is also the possibility of preparing specific documents, such as but not limited to Master Plans for System Validation or Equipment Qualification, Validation or Qualification Plans or Protocols, Risk Assessment, Inventory and Procedures, among others.