The right software for your Digital Quality Management

Increase and accelerate the security of your processes with digital QM solutions

Maximum quality is essential in your business - especially if you operate in a regulated environment. A digital QM solution can help you maintain this long-term.

QM system in compliance
with regulations

Transparent
processes

Traceability of
individual steps

Automated handling
of processes

Components of a good quality management

Control quality processes

Quality processes are always critical. That’s why they must be controlled and well documented. But how can you measure your contribution to the quality of your products and services?

You quickly and securely have up-to-date work specifications in the right place

Document Control

Your employees have the appropriate qualifications

Qualification
Management

Your quality records are documented securely and can be located later

Document
Management

You implement your quality-relevant changes in a controlled and targeted manner

Change Management

You handle processes quickly and to the satisfaction of your customers, even if something has gone wrong

Complaint
Management

CAPA-Management also helps you learn from experience and drives targeted improvements. Before long, that means reduced costs.

For this reason, it’s crucial that the associated processes run smoothly. The top priority: Preventing deviations and being able to react quickly and appropriately in an emergency - the right QM software makes this possible.

What is Quality Management software?

QM software helps companies to control and optimize their quality management and to meet the associated regulatory requirements. The aim is to simplify processes because QM procedures are often still processed on paper. There is a great deal of concern that this paper-based approach is the only way to comply with the relevant regulations, but this worry is unfounded. Suitable software solutions are fully compliant with the relevant specifications in the regulated environment.

For you, this means digital workflows at the click of a mouse instead of time-consuming, complicated paper processes.

Pauline_Explaining

The 6 key benefits of QM software:

QM laws, guidelines and standards

with partnerships

YAVEON relies on the QM solutions of our partner d.velop Life Sciences

Consulting expertise meets proven features: YAVEON and d.velop Life Sciences - the perfect combination. YAVEON has years of experience and expertise in the regulated environment and serves numerous clients in the pharmaceutical and medical technology industries. The d.velop Life Science modules are precisely aligned to the needs of customers from the regulated environment and provide a solid foundation. The combination of professional consulting and smooth-running products is unbeatable. Take a closer look.

Logo d.velop Life Sciences

QM software that delivers what it promises

Get to know the following modules

Controlled Documents

Create, revise, check, sign: You can do all this with the appropriate module for controlled document routing - regardless of the document type. Find out how to reduce resources as well as manage them digitally, increase data security, and much more.

Training Management & E-Learning

Take advantage of even more features by expanding the "Document Control" module to include training management. Plan and record employee qualifications digitally from now on. Ensure training activities take place, manage document linkage, increase data security, and much more.

With e-learning, you train employees digitally. Create e-learning content using Microsoft PowerPoint with a wide range of media such as videos, audio files, or documents. Alternatively, you can integrate existing presentations directly. Find out how you can minimize process run times, conveniently evaluate them, and easily access e-Learnings at any time.

Complaint Management

Do you want to control production-related QM processes, such as complaints, with digital workflows? You can achieve this with the Complaint module for Digital Complaint Management. Find out how you can meet regulatory and internal requirements, work transparently, reduce process costs, and much more.

Deviation Management

Deviation reports and other QM processes around the production can be reliably controlled with digital workflows. Instead of using paper, you can handle your deviation management completely digitally. Find out how you can prevent accidental loss of deviation messages, reduce process cycle times, configure modules to your liking, and much more.

CAPA Management

Control Corrective and Preventive Actions (CAPA) digitally? This works with the appropriate workflows - and you get them with the CAPA module. Find out how to ensure complete traceability, operate transparently, generate reports and statistics on your CAPAs, and much more.

Change Management

Digital workflows for QM processes around the production, for example, change controls. Yes, you can do this with the right Change Management software. Find out how to meet internal and regulatory requirements, how to link change management to other processes, how to configure the module individually, and much more.

Curious to learn more?

YAVEON QM modules - partner solutions of d.velop life sciences

In our YAVEON QM modules factsheet, you will learn

  • how to organize controlled documents,
  • how to respond if something goes wrong,
  • how to plan and record qualifications of your employees
  • how to integrate modules and systems,
  • how to train your employees
  • and much more.
Preview Factsheet Digital Quality Management

Questions are there to be answered.

The most important FAQs about Quality Management

What is quality management?

Quality management addresses the meeting of requirements. In this context, a quality management system describes a structured, planned, and continually repeatable procedure for meeting these requirements.

Which requirements should be met by quality management?

First and foremost, it is about what customers expect from a company's products and services. In the company itself, it is advisable to also consider colleagues as customers. This ensures that the requirements of the stakeholders are prioritized for every service.

What are the tasks of quality management?

Quality management shows how quality is generated in the company. This works based on a collection of aligned rules, responsibilities and processes, and the definition of responsibilities and accountabilities. Together, this creates a quality management system.

What is a quality management system?

A quality management system denotes the activities with which the predefined or specified objectives can be achieved. Software solutions are a particularly efficient, time-saving, and reliable way to achieve these goals.

What are the components of a quality management system?

Everyone in the company bears responsibility for quality. A central quality management (in the sense of a responsible department) ensures a holistic view of processes and responsibilities, identifies strengths and weaknesses, and supports employees and management in the strategic and operational alignment of the quality management system.

What is the key to successful quality management?

It is crucial that everyone agrees to cooperate on functional quality management and to adhere to, and constantly improve, the agreed conventions. The aim is to facilitate transparency of processes and procedures. Associated with this is the training of employees and the effectiveness of the quality management system.

Do I need to purchase a base to install the QM modules?

The basis is the Document Management System d.3ecm. Combined with the QM modules, the result is a QM system. If you don’t need a complete DMS, reduce the number of licenses required. You can buy or rent licenses as you prefer.

Can I also buy individual QM modules?

Yes, the QM modules can be purchased individually. However, some modules complement each other perfectly, for example, e-learning and training management.

What will digital quality management cost me?

The price of a QM solution depends on individual factors such as the number of users, modules, and special requirements. Your YAVEON consultant will help you to determine the ideal project scope and provide a customized offer.

Can the QM modules be introduced in a validated manner?

Yes, the solutions focus in particular on companies from the regulated and validated GxP environment.

Can I simply add more modules to my quality management system?

Yes, if required, you can expand your QM solution piece by piece with additional modules.

Do the QM modules work in compliance with regulations, and which ISO standards are fulfilled?

The software solutions are compliant with relevant laws, directives, and standards in the regulated environment: FDA 13485 CFR Part 2017/745, EU GMP Guide Swissmedic, MPG ISO 15189 MDR 17025, ISO 9001, 14001, 16949 and 17025, ISO 9001, 14001, 16949, IFS, BRC, GMP+.

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