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GMP - Quality Assurance Digital Solution

The solution for digitizing GxP & GMP Compliant processes

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GMP - Quality Assurance Digital Solution

GMP & GXP Digital Solution

The digital transformation of processes in these specific markets, has led to the automation and digitalization of all business processes, with particular attention to the production department and Quality Assurance.
Digitalization in these sectors has allowed companies to equip themselves with new methods in the management of activities that were previously managed on paper. This has made it possible to speed up the management of procedures and daily workflows, while ensuring the quality of products in compliance with good manufacturing practices (GMP and GXP) imposed by national and international supervisory bodies.
GMPs are a set of rules, procedures and guidelines to which every company must adhere, to ensure that the products manufactured are of adequate quality. The application of GMPs should therefore be considered as a dynamic process that progresses with the evolution of the available technology while maintaining the main focus on Product Quality Assurance.

The Adiuto solution has been developed in accordance with GAMP 5 and complies with FDA 21 CFR Part 11 and EU GMP Annex 11.

One platform for 4 systems

The solution integrates and manages 4 document areas and their related processes.

DMS | Document Management System

Documents can be entered in any format (PDF, Word, Excel, jpg, etc.). Non-digital documents are scanned and imported into the software that acts as a document “closet”.

Advantages

• Access to the archive and documents with a click from anywhere and on the go; • speedy consultation and retrieval of information; • time frame management that alerts the user, through an alert system.

Managed Document Areas

Audit reports / Supplier certificates / Evaluation questionnaires / Batch records / Validation reports / Regulations

QMS | Quality Management System

Drafting, verification, approval and distribution of the approved document.

Advantages

• Alert Revisions to be done; -•Constant monitoring of the document status, its progress and possibility to receive notifications about possible delays in the issuance of the document; • Publication of the various documents and storage of the different versions as required by law; • Approval with electronic signature; • Viewing documents directly from mobile devices without having to print them; • Printing documents with a controlled printing system; • Document reconciliation.

Managed Document Areas

SOP – I.O. / Modules / Monographs / Validation protocols / Master Batch records / Reconciliation / Operational batch records

ECM | Content and Process Management System

The documents necessary to ensure the company's quality system and coordinate information related to document processes.

Advantages

• Transformation of the form from paper to digital and compilation of all the parts of the document pertaining to the various managers involved in the process; • Management of lists of managed processes, alerts and tasks; • Electronic signatures.

Managed Document Areas

CAPA / Change Control / Deviations / Complaints / Audit reports / Non-compliance

TMS | Training Management System

The profiles managed by the organization chart are combined with the various training plans, keeping the training needs of each managed user under control.

Advantages

• Proactive system in that it proposes what training needs to be done based on new SOP procedures, revisions made, new employees hired or those who have changed roles; • Develops the training list for each user and monitors the training needed; • Schedules the expiring training list and allows for scheduling of new courses.

Managed Document Areas

Quality Training / Safety Training / Environment Training

Resilient

Configurations and processes are designed to facilitate business and process changes, it will no longer be traumatic to deal with change requests, because Adiuto accommodates what is needed, seamlessly.

Compliant

The reference standards and the validation required to use a software in the regulated world are not an obstacle; on the contrary, Adiuto is compliant and offers a 360 degree view of the data and full adherence to data integrity. It complies with the requirements of 21 CFR Part 11 of the FDA and Annex 11 (Annex 11) to Volume 4 of the EU-GMP and is able to be validated. The platform is equipped with Electronic Signatures, Audit Trails, and Controlled Printing. It ensures compliance with data integrity regulations and cornerstones by increasing reliability for regulators and customers. It is a system that allows you to always have the progress of your processes (audit trail) and access under control.

Scalable

It is possible to customize the different streams directly from the web interface. It was developed natively as a web-based and mobile solution. The "server side" solution can reside indifferently on a physical server or on virtual server, giving the customer maximum freedom on infrastructure choices.

This means that nothing is installed on the customer's devices, making maintenance on the users' machines much easier. The interface is adaptive; therefore, it is configured according to the device from which you access the system. Thanks to all of these main features, it is a fast product to bring to go-live. It is scalable and suitable for companies of any type and size, which makes it attractive even to companies that because of implementation cost or timing reasons have not yet been equipped with such systems.

Simple

Adiuto users of the pharmaceutical world are the most satisfied among the users of the Platform and this is because the reference regulations make historically very complex the adoption and then the use of software for critical processes, with Adiuto instead the logic of the product make daily use simple and immediate.

The simple system administration interface contains all the configuration features. Nothing is written in code, everything is configured by system parameters. The ease of configuration means that the administration skills of the system can also be transmitted to the customer in order to make it autonomous in the configuration of subsequent flows