Quality Manager Life Science

The leadingQMS software
for the Life Science sector

We already help over 200 companies in the life sciences sector to support their operational efficiency, control risks and ensure compliance with standards and regulatory requirements such as ISO, GxP and FDA 21 CFR Part 11 with QMS software dedicated to the Life-Science sector.

Dematerialization of your EHSQ management system
With Avanteam Mobile, take your solution on the field 

500+ companies trust us

A turnkey QMS solution !

Mastered documentation | Automated processes | Trained employees

QMS - Avanteam Quality Manager software is based on market best practices and capitalizes on over 20 years of collaboration with companies in the Life-Science sector.

As standard, it offers you all the key functions to simplify the management of your quality & regulatory documents and processes.

Document management

Document Life Cycle Management
Customizable document templates and templates
Centralized distribution to all actors

Events and action plans

Management of non-conformities, customer complaints, deviations and change-control
 360° vision of the action plans in relation to the original events
KPI and steering indicators

Risks

Managing all types of occupational hazards
Mapping according to your organization: establishments, zones, work units and activities, etc.
Centralized governance linked to action plans

Health, Safety, Environment

  • Centralized database for managing Health, Safety and Environment data
  • Declaration of health, safety and environmental events and their analysis using the cause tree approach
  • Action tracking and automatic report generation

Supplier evaluation

  • Extranet and centralized supplier register
  • Initial and periodic assessments 
  • Non-conformity monitoring and action plans
  • Mobile audits and inspections with customizable questionnaires available on all iOS, Android and Windows devices

Training and authorizations

  • Mapping trades and skills in relation to your employee reference systems
  • Training planning and follow-up
  • Management of authorizations and certificates
  • Follow-up to periodic interviews and assessments

Modular Life-Science QMS software to support your operational excellence

Build your QMS solution according to your needs, combining one or more of the following modules:

Quality Document Manager

Document Management

Collaborative drafting of documents

Version control, releases and acknowledgements

Microsoft Office and Google Workspace integration

Management and follow-up of requests for review

Quality Improvement Manager

Continuous Improvement

Management of non-conformities, customer complaints, deviations, change-control and action plans

Planning and follow-up of internal, external and supplier audits

Monitoring of training, skills and authorizations

Real-time monitoring of actions by process, event, stakeholder, site, entity, customer, etc.

Quality  Risk manager

Risk Management

Centralized repository of occupational hazards and their mapping according to your organization: establishments, zones, work units and activities, etc.

Assessment of occupational risks of all kinds: physical, chemical, biological, radioactive, quality, etc., using the appropriate method: severity, probability, frequency of exposure, duration, detectability, FMECA, 5M, etc.

Planning and collaborative follow-up of corrective and preventive actions

Automatic generation of Single Documents and other documents for occupational health and safety professionals.

A more proactive quality thanks to Artificial Intelligence

Avanteam is one of the first QMS software companies to offer AI to support quality managers in their daily decision making.

Avanteam AI, 🤖 applies natural language processing (NLP) and machine learning (ML) to all of your quality management system (QMS) data in order to propose action plans that have proven to be effective in dealing with similar past events: non-conformances, complaints, deviations, accident reporting, audits, etc.

With Avanteam AI, you will benefit from intelligent recommendations, reduce investigation and decision-making time and resolve quality incidents faster.

Criteria for choosing your QMS software

QMS software always in line with ISO, GxP and FDA 21 CFR Part 11 requirements

When you choose Quality Manager, you're opting for integrated, scalable QMS software that's constantly in step with the various ISO 9001, 14001, 45001 and 18001 standards, as well as sector-specific requirements: ISO 13485, 17025, 17020, 15189, 9100, and regulatory requirements: GxP.

What's more, thanks to its ability to manage dual electronic signatures and ensure full traceability of modifications via audit-trail, in compliance with FDA 21 CFR Part 11 requirements, Quality Manager is perfectly suited to players in the Life-Science sector: pharmaceuticals, cosmetics, biotechnologies and medical devices.

Download our white paper which explains the 10 key criteria for choosing the QMS solution that meets the requirements of Life-Science players. 

Avanteam Mobile

Unleash the potential of your teams on the field, providing them with secure access to their processes, documents and tasks from any iOS, Android or Windows Phone device.

Benefits of the solution

Guarantee your compliancewith regulatory requirements: ISO, GxP, FDA 21 CFR Part 11, etc.

Cut the cost of handling non-conformities, complaints, deviations and action plans by a factor of 5 .

Involve your staff in your improvement process and create a "results culture".

Real-time access to constantly updated indicators and dashboards

More proactive quality and more relevant decisions, thanks to l'artificial intelligence

Accelerate your digital transformation and give your company a modern image

They talk about it better than we do

What seduced the users and myself, are the modernity of the interface and the functional richness of Avanteam solutions.

Claude BOUR
RAQ
@SERMS

With Avanteam Process Studio, we have already automated around ten value-added business workflows for the company.

Matthieu Niclot
Digital Coordinator
@Aplix

We chose Avanteam for the speed of implementation and the ability to customize the solution independently.

Mathilde Borel
Head of IT - Finance
@SAMSE

Why Avanteam?

Find out why customers choose Avanteam

Ergonomic

We think first of the end user with the objective of simplifying his life.

Customizable

Our solutions adapt to your organization and grow with your strategy, not the other way around.

Open

Avanteam integrates easily with the main software of the market: CRM, ERP, HRIS, etc.

Our total commitment to your success

Beyond software, Avanteam's success lies in the expertise of its teams in the Life-Science sector and their commitment to the success of customer projects.

Mobile

Access Avanteam anywhere, anytime, from any iOS, Android or Windows terminal.

Autonomy and freedom

Avanteam is accessible to functional users, who can manage their application autonomously and without any technical skills.

Cross-functional approach

Dematerialize all your business processes with a single platform, reducing licensing and training costs.

Innovation & Leadership

Thanks to its innovative software suite and the loyalty of its customers, Avanteam has enjoyed double-digit growth for many years, and is now a market leader with over 500 customers in Europe.

 

Our experts are at your service

A question? a quote? a request for a demonstration? it's quick and easy...

Aren't you comparing several QMS software packages?

Save time by downloading the QMS software comparison kit.

How to choose your quality management software (QMS)?

What is the advantage of Life-Science QMS software over the quality modules of certain ERP or CRM software packages?

  • It depends on your needs and what your ERP or CRM software can cover as standard. Some ERP or CRM software offer quality modules that manage part of the quality process, in particular the management of non-conformities or the follow-up of customer complaints. However, these softwares are far from offering the same functional coverage or the same ergonomics as a dedicated quality software that has been designed to meet all your normative and regulatory requirements, by involving the largest number of users in your progress and continuous improvement processes.
  • Integrated, turnkey QMS software such as Avanteam Quality Manager lets you manage all your quality documents and processes from a single tool, giving you a 360° view of all your action plans in real time. It can also evolve autonomously and more easily than ERP or CRM software.

Do I have to subscribe to all Quality Manager modules?

  • No, as we often say to our customers "Think big, but start small". You can deploy each module at your own pace by subscribing to the service you need the most at first.
  • If necessary, you can then deploy the other modules to create a complete quality management system (QMS), capable of managing and controlling all your normative and regulatory requirements.

How to compare quality management solutions?

  • It is always tempting to want to compare a lot of software. In practice, we advise you to draw up a functional and technical checklist and fill in the key features you need. Then look for quality software that matches your checklist. This will considerably simplify your work and make it more efficient. Three to forty software packages are usually enough to make a relevant comparison.

  • In addition to your checklist, check the editor's customer references, particularly in your sector of activity, as well as their ability to advise and support you in the implementation of your project.

  • The existence of an active "User Club" is also an important criterion. This allows you to verify that the editor devotes sufficient time and energy to the evolution of its solution so that it is constantly in phase with the state of the art, as well as the latest regulatory and professional requirements.

How to calculate the ROI of a quality software?

  • There are many methods to calculate the return on investment of a software. Here is a relatively simple one for quality software:

    - How many employees are in charge of managing QHSE documents and processes? What is their average hourly wage, including charges?
    - How many hours per day, on average, do they devote to the management of quality documents and events: audits, RC, NC, action plans, etc.?
    - Number of employees X Average hourly wage X Number of hours devoted to quality = Daily cost dedicated to quality management.
    - Multiply this daily cost by the number of working days in your company to get the annual cost dedicated to quality management.

    A quality software can generally divide this cost by 3 by automating all the manual and time-consuming tasks. Now you have to calculate your return on investment, by deducting from the annual cost of the quality software, the 2/3 of management time saved thanks to the software. Do not hesitate to contact our customer service to have a small ROI calculator that you can customize according to the context of your organization.

    This calculation only takes into account the quantifiable gains, but the "qualitative" benefits of dematerializing your QMS should not be overlooked:

    - More time available for higher value-added tasks
    - Better quality of life for your employees and more involvement in your continuous improvement process
    - Team autonomy
    - Better overall process management.

Can I use the tool on the move on the field?

  • Yes, Avanteam's mobile application, offers your teams in the field, secure access to their processes, documents and tasks, from any iOS, Android or Windows Phone device. This allows them to :

    - To seize and go up from the field, including in disconnected mode, any type of information:
    . declaration of incident, complaint customer, card of intervention,
    . audit or inspection, visit customer, report of activity,
    . follow-up of building site, state of the places, statement of hours, ...
    - To follow the state of progress of a file, from everywhere and constantly.
    - Participate in workflows and make decisions: process an action plan, validate a document, ... but also intervene in other collaborative processes that can be digitized by Avanteam: purchase request, leave, expense reports, contract signing, etc.

Does the solution allow for a recovery of the existing?

  • Yes, Avanteam will help you for the recovery of your existing documents and records, by associating the competences of its teams of experts to a very powerful tool of mass import of the external data and documents.
  • The recovery of existing documents and records is often a critical step. It is not only a matter of retrieving the documents or files and loading them into the Quality Manager tool, but above all of entering the metadata (document title, reference, process concerned, internal signatory, third party signatory, signature date, expiry date, etc.) which will enable them to be classified and found easily.

What are the main benefits of an electronic quality management solution (eQMS)?

  • Full visibility of your management system 

  • Real-time monitoring of action plans: what? who? when? why?

  • 3-fold reduction in processing time and costs

  • Eliminate the risks associated with manual quality management

  • Quick and relevant decisions thanks to immediate access to information

  • Better involvement of employees in your progress initiatives

  • Strengthened relationship with your customers and suppliers 

  • Traceability and compliance of your management system

  • Integrated and centralized management of your EHSQ processes.

Can I dematerialize and automate other processes than quality with Avanteam?

  • Yes, beyond its business solutions such as Quality Manager, Avanteam provides you with a modern platform for document digitization (EDM) and business processes (BPM) which is Process Studio.

  • With Process Studio, you can create in record time and without coding, your own collaborative applications: purchasing, supplier invoices, mail, customer service, vacations, expense reports, recruitment, staff entry/exit, legal, IT, etc. This way,your teams will no longer have to juggle spreadsheets, emails and other tools to manage and coordinate their activities.

  • The tool is accessible to both business decision makers and technical experts. This guarantees that your application will easily adapt to organizational changes or functional requests from users, without additional development costs and without soliciting external or internal IT teams.