The Quality Assurance and the digital management of quality processes
New technologies are a key tool for compliance and can greatly simplify the work of QA.
Quality Assurance and IT are the areas most affected by digital transformation. This is also confirmed by a survey published by KPMG.
The study, based on a sample of more than 75 industry leaders, provides insights into the effects of digitalization in the life sciences industry, the changes underway at individual companies, and how the sector is shaping the future.
Source:“Digitalization in Life Sciences – Integrating the Patient Pathway into the Technology Ecosystem”
Quality Assurance
Overview of the Implementation of Digitization Projects in Internal Departments (multiple choice, in %)
Source: KPMG in Germany
According to industry leaders, the benefits resulting from the implementation of digital technologies are:
Internal efficiency; Optimization of quality and compliance processes; Increased patient engagement and loyalty (patient-centricity); A broader range of products and services.
Source:“Digitalization in Life Sciences – Integrating the Patient Pathway into the Technology Ecosystem”
Paperless
A GxP mantra is: “If it’s not written down, then it didn’t happen.”
Quality Assurance is a field in which, to ensure product quality and safety, it is essential to track every activity, document it, and go through approval (signature) cycles that involve various areas and departments within the company.
To do this, many companies still rely on paper, or at least on tracking systems that are not fully structured.
Paperless
A GxP mantra is: “If it’s not written down, then it didn’t happen.”
Quality Assurance is a field in which, to ensure product quality and safety, it is essential to track every activity, document it, and go through approval (signature) cycles that involve various business areas and departments.
To do this, many companies still rely on paper, or at least on tracking systems that are not fully structured.
Using a methodology that relies on paper or hybrid (paper/digital) documentation exposes companies to the risk of inefficiency and compliance issues. This is because documents could be lost, tampered with, or not always up to date. It is in this context that having access to
technologies capable of keeping documentation up-to-date, traceable, and secure—
—plays a key role for the QA department.
Technologies Supporting the Quality System
Document Management Software (DMS)
Technology designed to track, store, manage, and control a company’s documents and files. There are many Document Management Software (DMS) solutions available on the market, some more suitable than others depending on the type of business, as well as the applicable laws and regulations.
Quality Management Software (QMS)
Technology capable of centralizing and facilitating the sharing of quality information, as well as the management and analysis of data, documentation, and responsibilities. It typically allows for the management of quality processes such as: audits, change control, deviations, equipment maintenance, nonconformities, complaints, employee qualifications, and procedures.
Quality Management Software (QMS)
Technology capable of centralizing and facilitating the sharing of quality information, as well as the management and analysis of data, documentation, and responsibilities. It typically allows for the management of quality processes such as: audits, change control, deviations, equipment maintenance, nonconformities, complaints, employee qualifications, and procedures.
Quality Management Software (QMS)
Technology capable of centralizing and facilitating the sharing of quality information, as well as the management and analysis of data, documentation, and responsibilities. It typically allows for the management of quality processes such as: audits, change control, deviations, equipment maintenance, nonconformities, complaints, employee qualifications, and procedures.
Workflow Management Software (WFMS)
Often, companies choose to integrate DMS and QMS into an all-in-one solution that leverages workflow management software (WFMS) to achieve comprehensive digitization of all workflows and documentation within the company. The WFMS allows users to capture data, share information, perform tasks, attach documentation, and manage communication and the handoff of tasks from one employee to another according to a set of procedural rules.
Technology Integration
Just a few years ago, it was unthinkable to automatically receive data from production machinery and automate processes. Today, however, thanks to Industry 4.0, we are moving increasingly toward the integration and interconnection of different technologies. This makes work easier across all areas of the company, enhances quality control, and even allows us to explore new ways to utilize the vast amount of data available.
In order to navigate the ongoing changes, the Quality Assurance Department is expected to develop a stronger digital culture, a holistic approach to data analysis, and a dynamic mindset capable of adapting to ever-evolving technological changes.
Given this commitment, the benefits in terms of data processing, quality assurance, efficiency, and increased compliance are truly significant.
PRAGMA4U integrates all of the technologies mentioned into a single platform.