For this customer in the highly regulated life sciencesit was essential to have reliable, reputable QMS software capable ofeliminating multiple sources of information, eradicating human error, reducing risk and costly delays, and ensuring that employees, customers, partners and regulators all had confidence in the quality management system (QMS).
In addition, the management of audits, inspections as well as the processing of events (non-conformities, customer complaints, deviations, ...), changes (change-control), and action plans (CAPA) mobilized a lot of resources with little result, due to a manual management of the continuous improvement loop carried out for the most part via Excel files and emailing
After evaluating several software packages, this pharmaceutical laboratory finally chose QMS Quality Manager Life Science software from Avanteam, which perfectly met their specifications (URS), both in terms of functional coverage, and its ability to meet regulatory(GxP, FDA 21 CFR Part 11, ISO) and IT security(ISO 27001, RGPD) requirements.
Today, over 1,200 users in 6 European countries rely on Quality Manager - Avanteam's Pharma & Cosmetics quality software - to manage document life cycles, process non-conformities, deviations, complaints, change-control, manage audits, training and authorizations, prevent risks, monitor action plans, and steer process performance.
The return on investment
For the group's Quality Director, Avanteam's Quality Manager Life Science solution offers the following benefits:
- Integrated Quality Management System : a single, reliable quality reference system (QMS), capable of ensuring the conformity of products and services at all the group's sites and countries.
- Better involvement of employees in the continuous improvement process: thanks to an ergonomic portal that gives them immediate and personalized access to important information and reminds them if they are late.
- A 360° vision of the action plans whatever the origin of the events, observations and incidents.
- Comfort and simplicity of use: thanks to an ergonomic interface, everyone can access their documents, tasks and actions in real time, even when on the move.
- Reliability and traceability : thanks to the centralization of information, the strict application of access rights as well as audit-trail and digital signature.
- A proven and scalable solution: based on the best practices of the pharmaceutical and cosmetic industry, Quality Manager already equips hundreds of companies in the life sciences sector by allowing them to manage their management system (QMS) with more comfort and reliability. For the customer it is the guarantee to invest in a quality tool that will be constantly in phase with the state of the art as well as the various regulatory requirements of the Life Science sector: FDA 21 CFR Part 11, GxP, EU MDR, EU RDIV, ISO 13485 and ISO.
- Openness and evolution: beyond quality, the forms and workflow generator integrated in the solution will allow the computerization of other processes such as the follow-up of destructions, derogations, manufacturing rework, supplier returns, customer analysis requests, pilot lots and equivalence tests.
To go further
Today, there are more and more quality management players and offers on the market with different functionalities and approaches.
It is therefore important when making your choice, to take into account the following criteria:
- Choose a solution capable of meeting the various normative and regulatory requirements : with Quality Manager, you opt for an integrated and scalable management tool, which will be constantly in phase with the various standards and regulatory requirements: ISO 9001, ISO 14001, OHSAS 18001, ILO-OSH 2001, EN 9100, ISO 22000, ISO 26000, ISO 13485, ISO 15378, EN 15986, ISO 28620, ISO 17025, ISO 15189, MASE, FDA 21 CFR 11, QUALIBAIL, etc.
- Choose software that is accessible to operational staff, allowing you to maintain your management system and, if necessary, reconfigure your forms and workflows, without going through heavy and expensive development.
- Do not forget the user interface and the ergonomics of the application. Your users should be able to use it after a one-hour training, or even a simple online training.
Our clients testify
What seduced the users and myself, are the modernity of the interface and the functional richness of Avanteam solutions.
With Avanteam Process Studio, we have already automated around ten value-added business workflows for the company.
We chose Avanteam for the speed of implementation and the ability to customize the solution independently.
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