BREAKTHROUGH

GO!FIVE is a responsive, cloud-based Paperless Systems Validati on platf orm designed for use on computers, laptops and tablets. Our breakthrough technology is changing the way validati on is done. In additi on to making zero use of paper, GO!FIVE enables you to reduce project completi on ti me by up to 65% - securely and effi ciently.

GO!FIVE’s Agile structure facilitates team integra� on and speeds up document exchange among project collaborators. Its fl exible pla� orm enables each individual project item to be managed independently, allowing valida� on reports to be released by module, by specifi c equipment, or area of produc� on.

GO!FIVE

Validation for Life Sciences

www.fi vevalida� on.com

Reduce Valida� on Time by up to 65% with GO!FIVE

Paperless GxP

Backed by Experience - Backed by FIVEUnlike the compe� � on, who are latecomers in the fi eld, or who off er so� ware which “also does” valida� on, GO!FIVE has the benefi t of Five Valida� on’s deep experience. For over a decade, we’ve been doing nothing but valida� on, earning an Interna� onal reputa� on that is unsurpassed in the industry. Year in, year out, we have seen the disadvantages of paper-based valida� on, which has given us valuable insight from which to solve the challenges of valida� on.

The GO!FIVE paperless validati on platf orm is simply the logical next step in FIVE’s eff ort to off er the world’s best validati on service.

Tested, Proven & Compliant! Valida� on is what we do best - and when we set out to create the world’s most fl exible, secure, and intui� ve paperless VLMS, we applied the same mindset, me� culously following GAMP5 best prac� ces, and incorpora� ng fi lters for access control, electronic signature, audit trail, and data integrity as required by FDA 21 CFR Part11. GO!FIVE is GAMP5 and ANVISA compliant, with special a� en� on to important items related to ISO 27000 standard, data integrity and privacy, as well as risks related to hos� ng the so� ware with Amazon (AWS) in the United States. The product has been proven compliant at every phase, with documents having been extensively authored and validated throughout the process to ensure op� mal performance, stability and effi ciency.

Superior Knowledge Base LibraryOnce a system is registered in GO!FIVE, a pre-ready knowledge set is created, appropriate to the task at hand. GO!FIVE’s Knowledge Base Library then suggests relevant content about the system to be validated, based on data which has been entered. The library can be pre-selected to address compliance and regulatory items (i.e. FDA 21 CFR Part11 and data integrity) specific to computer systems and applications commonly used in Life Sciences companies. The library is continuously learning and updating as new systems and technologies emerge, helping to accelerate the validation process and reduce potential errors of omission.

100% Digital Review/Approval Workfl owGO!FIVE has the ability to easily gather items from diff erent deliverables and form them into new packages, and send them out for review and approval. Once a package is reviewed, it can then be securely approved via electronic signature, making the en� re review/approval process digital. Upon approval, the package gains “approved” status, is automa� cally updated and re-versioned, and cannot be altered unless a new version is jus� fi ed and traceable to a Change Management ID.

GO!FIVE - the next step in paperless validati on

We assessed all the challenges and issues faced during the validati on process and identi fi ed the key components required to create an opti mal digital VLMS. This led to the development of a Superior Knowledge Base Library containing pre-ready validati on/qualifi cati on documents compati ble with the most common computer systems used by Pharma, Biotech, and Life Sciences companies.

Automati c Traceability MatrixWhen GO!FIVE is used, all ac� ons taken are automa� cally recorded, iden� fi ed, gathered and assembled into a Traceability Matrix. This eliminates the need for the Analyst to manually search through mul� ple documents for informa� on, thereby reducing the risk of data inconsistency and human error. Most importantly, the automa� c traceability matrix greatly reduces valida� on � me, yielding drama� c savings in overall project cost.

PaperlessValidati on

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ITEM-BASED VALIDATIONEasy Management Change Control – Agile Valida� on 4.0

Reduced Time - Increased Effi ciencyDuring the valida� on process, Analysts typically take part in many mee� ngs to collect informa� on, and study countless systems and user guides. Addi� onal � me is spent running IQ (Installa� on Qualifi ca� on), OQ (Opera� on Qualifi ca� on) and PQ (Performance Qualifi ca� on) tests and fi lling the results into various worksheets and documents. In the tradi� onal paper model, the valida� on process produces long documents which take a long � me to author and test. Moreover, it is challenging to control and maintain valida� on status through such a complex process. GO!FIVE greatly reduces � me and increases effi ciency by elimina� ng the high degree of manual labor required for these tasks, streamlining the most repe� � ve processes, and crea� ng a robust yet highly usable tool for informa� on management.

Customizable Client Template LayoutThe pla� orm off ers document templates that can be customized to client specifi ca� ons for each deliverable. Tags are inserted in the template, each corresponding to a par� cular piece of informa� on. GO!FIVE automa� cally searches for the informa� on and displays it in the correct posi� on within the confi gured layout (some technical restric� ons apply).

Agile Release of DeliverablesGO!FIVE can easily assemble and release a group of review/approval packages, comprised of items that are any parts of the traceability matrix, be they requirements, specifi ca� ons, risks, or tests. These releases are then used to perform a por� on of the whole valida� on, according to the criteria defi ned by the team, whether by so� ware development phase, area, system, equipment, or other, and a valida� on report can be generated for each release.

PaperlessValidati on

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With current models, if any changes are required in the validati on documentati on at an advanced stage,

all the previous documents must be updated and manually versioned, costi ng ti me and money.

With GO!FIVE, the items in each document are treated independently, while maintaining their links and audit trail throughout the changes. Items can

be grouped in Releases, greatly reducing cost.

CURRENT MODELSWaterfall

GO!FIVE AGILE MODELItem-based

Informati on Security & Data PrivacyFIVE is commi� ed to the highest levels of security and confi den� ality. All project documenta� on generated by GO!FIVE is property of the client, and is stored on a dedicated high-performance server with interna� onal cer� fi ca� ons and qualifi ca� ons. Each client has a par� � oned sec� on of the database, and it is not possible for one company to access another’s data. Clear security policies assure that FIVE employees are not authorized and should not access client’s valida� on data to generate the knowledge base library, except when requested by the client to be involved or to collaborate.

Supported by FIVE - The GxP Validati on ExpertsAs interna� onal legisla� on for GxP is constantly changing, FIVE Valida� on has developed programs targe� ng Life Sciences which help companies comply with the most current regula� ons. FIVE assists companies in fully preparing for audits and inspec� ons by customers, or by the government. We perform valida� on of computer systems, equipment and facili� es automa� on, infrastructure qualifi ca� on, data integrity, data governance and data protec� on. Five can be contracted to provide valida� on services ranging from defi ned scope to complete lifecycle, consultancy services, pre-audits, supplier’s assessment, valida� on projects management, as well as the GO!FIVE SaaS VLMS Valida� on Lifecycle Management System.

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Handy Offl ine ModeGO!FIVE Offl ine was designed to allow you to use the pla� orm even when an internet connec� on is not available. Two ac� vi� es can be performed in offl ine mode, and then synchronized at a later � me with the cloud: Risk Analysis and Test Execu� on.

User-Friendly DashboardThe dashboard is your GO!FIVE home, providing important informa� on about projects such as project progress and status, total items, percentage of comple� on (from a single valida� on or a set of them), number of incidents, and fundamental func� onality to monitor team performance. The GO!FIVE dashboard is designed to be fl exible, useful, and intui� ve.

Visit our website for more informati on www.fi vevalidati on.com.

www.fi vevalida� on.com