Bluenext

Why Choose Adiuto 4 Life Sciences

Compliant and validatable

Developed in accordance with GAMP 5, it complies with FDA CFR 21 Part 11 and EU-GMP Annex11 regulations.

Reliable

Ensures compliance with regulations and data integrity, including for regulatory bodies and clients.

Complete

A single platform to manage the Quality system and involve external stakeholders in processes.

Scalable and Modular

Easily adapts to the needs of companies of any type and size.

Web and Responsive

Natively web-based and mobile solution, accessible from PC and smartphone.

User Friendly

Easy to use for both internal users and external collaborators.

Simple to Configure

Easily configurable through the dedicated interface.

Easy Integration

Communicates with other software solutions in the company.

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OVERVIEW

Our Expertise Serving the Pharma and Life Sciences World

In the pharmaceutical world and Life Science sector, data uniqueness and traceability are fundamental.

Companies operating in these contexts rely on structured processes and need expert partners and consultants who can help them meet the organizational and efficiency challenges their market demands.

For over 20 years, we have been supporting Pharma and Life Sciences companies in their digital transformation journey, helping them manage critical processes involving Quality and Production personnel.

With Adiuto 4 Life Sciences, technology and expertise combine to create solutions for digitizing Processes, Documents and Content, serving businesses in regulated environments.

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FEATURES

The Modular Platform for all your Processes

Solutions for Digitizing GxP processes in Life Sciences, Pharma and Medical Device industries, configurable for every need.

The platform allows you to:

  • simplify and guide the management of complex processes
  • speed up the management of daily procedures and workflows
  • ensure product quality in compliance with national and international GMP and GxP practices.

 

How? Discover the modules available in Adiuto 4 Life Sciences:

ECM | Content and Process Management System

Allows you to manage all documents and processes necessary to ensure the company quality system and compliance in regulated environments.

 

Benefits

  • Transformation of forms from paper to digital format.
  • Digital completion of all document sections by various responsibles involved in the process.
  • Management of managed processes lists, alerts and tasks.
  • Electronic Signatures.

 

Examples of managed processes

CAPA / Change Control / Deviations / Complaints / Audit Reports / Non-conformities …and much more

QMS | Quality Management System

The module dedicated to drafting, reviewing, approving, and distributing approved documents.

 

Benefits

  • Revision Alerts.
  • Constant monitoring of document status and configurable notifications about possible delays in document issuance.
  • Publication of documents and retention of different versions as required by regulations.
  • Electronic signature approval.
  • Document viewing on mobile devices without printing requirement.
  • Document printing with controlled printing system.
  • Document reconciliation.

 

Examples of managed processes

SOPs – Work Instructions / Forms / Monographs / Validation Protocols / Master Batch Records / Reconciliation / Operational Batch Records …and much more

DMS | Document Management System

The module that allows you to acquire, index, catalog, and archive all your documents, including paper documents digitized through scanning.

 

Benefits

  • One-click access to archives and documents anywhere and on mobile.
  • Quick consultation and information retrieval.
  • Schedule management that notifies users through an alert system.

 

Examples of managed documents

Audit reports / Supplier certificates / Evaluation questionnaires / Batch Records / Validation Reports / Regulations …and much more

TMS | Training Management System

This module allows you to match training plans to organizational chart profiles and always keep track of each user’s training needs.

 

Benefits

  • Proactive system: suggests training based on new SOPs, revisions made, new employees hired or those who have changed roles
  • Develops training lists for each user and monitors required training.
  • Plans the list of expiring training and allows planning of new courses.
  • Electronic Signature and Audit Trail functions
  • Archives all training courses documents related to user training
  • Enables digitization of all training management activities

 

Examples of managed processes:

Quality Training / Safety Training / Environmental Training

CMS Web Composer | Web Portals from Adiuto Content

The module for creating configurable web portals to share content, data, documents, and processes with external parties.

 

Benefits

  • Real-time internal and external sharing of projects, documents, notes, and attachments.

  • Internal and external approval cycles for projects, documents, notes, and attachments.

  • Secure document publication for clients/suppliers/third parties or any entity the company needs to interact with.
  • Secure and parameterized upload of information or documents by external entities.
  • Simple or qualified electronic signatures with OTP for orders, files and other documents.

 

Examples of managed processes

Complete Supplier Qualification Management / Order collection / Proof of delivery / Return process initiation / Customer anomaly reporting …and much more

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Contact us for more information about Bluenext solutions for the Life Science sector, to schedule a free demo, or to request a quote.

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