Description de AssurX
Simplifiez la gestion de la qualité et la conformité réglementaire avec un seul système polyvalent. La plateforme AssurX est un système logiciel qui automatise la qualité et la conformité pour aider les entreprises à rationaliser leurs workflows, contrôler les risques et mieux gérer leurs opérations. Commencez par les fonctionnalités dont vous avez besoin maintenant et implémentez celles qui vous plaisent dès que vous serez prêt. Aucun autre système n'est aussi facile à déployer, à configurer, à utiliser et à modifier. Des entreprises de toutes tailles et de tous secteurs d'activité (c'est-à-dire des centaines de milliers d'utilisateurs dans le monde) font quotidiennement confiance à AssurX.
Qui utilise AssurX ?
Cette solution est particulièrement bien adaptée aux secteurs réglementés comme les dispositifs médicaux, les sciences de la vie, ceux sous réglementation FDA, la fabrication et les services publics, mais elle est idéale pour toutes tailles de secteurs ou d'entreprises.
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An agile solution that doesn't compromise on compliance.
Commentaires : We are a global drug company with manufacturing sites all over the world. Due to nature of the data in our system (product complaint investigations), we are continuously under inspection. In the 10+ years that we’ve been using CATSWeb, there hasn’t been a single observation regarding any of the system functionalities. The compliance features (record archiving, audit trails, eSig controls etc.) are comprehensive, easy to use, and reliable. In addition to compliance, the big benefit of CATSWeb is its agility. As a low code platform, we were able to train 1-2 Business Analysts (non-programmers) to develop and maintain our own applications without relying on software developers and our internal IT organization. With good process controls in place, workflow modifications happen in days (not weeks or months), thus avoiding costly development and software validation efforts. We have the capacity to deliver new functionality to users quicker than internal procedures can get updated, and without software engineers, DBAs, and project managers getting involved.
A low-code, agile software tool, with the ability to customize workflow applications without relying on software developers. Comes with comprehensive 21CFRPart11 compliance features that – when implemented correctly - satisfy FDA computer system compliance requirements. We report using Crystal, with end users entering their own parameters and executing without any software needed on client machines – which has worked very well for us. AssurX support has been outstanding. CATSWeb can be as simple or as complex as you need it to be, and with a comprehensive API, the possibilities are limitless for customizations and integration with other systems. We have yet to encounter any technical constraints with this tool. If implemented correctly, CATSWeb can automate many of your internal business processes and return great value to your organization.
Due to its highly configurable nature, requires solid, internal process controls for development activities (standardizing naming conventions, documentation of changes, governance etc.). To deal with this, we built an internal change management workflow directly within CATSWeb that captures all system changes – big and small – which has been incredibly effective. Any modification to our applications is linked to a change record that documents the reason for change, the actual change plan, the verification steps, and the review signatures. This has made the evolution of our workflows clean and efficient. Any software with extensive functionality is going to come with a significant learning curve, and CATSWeb is no different. Our recommendation is to assign a dedicated CATSWeb SME to learn the system and develop your applications. Investing in training early will pay back in spades down the road.
Alternatives envisagées :
Great flexible solution and a great team to work with from selection to implementation & use
We are hoping to transform our whole QMS with AssurX. Everything is currently manual on paper forms, but also because we are a growing company through various acquisitions, all sites work in different ways. So we are taking this as an opportunity to standardise where we can.
We will be taking various approaches of configuring and using some pre-configured solutions. We went live earlier this year with our NC and CAPA solution and working on Document Management and Complaints this year. Overall its probably a five year plan.
Overall we are really happy and they are great people to work with, they never complain about the many questions we ask, and we ask a lot, sometimes the same question because there is so much we are learning.
The pre-configured solutions were a bonus and helped make our decision on selection, even though the initial solutions we wanted to go-live with weren't good fits, the ease of configuration won us over. We selected this product on seeing an older interface, but when we came to implementation AssurX had developed a new interface which has been a huge help in making the system more user friendly and making it appear more modern to the users. I must say the AssurX team have been great to work with, from initial contact with Sales, to the onboarding, install, implementation support from their Professional Services and Validation support. Everyone has been so helpful and supportive and we couldn't have met our objective set by our senior management without them.
Whilst the configuration and flexibility has been great, I suppose its a double edged sword. We have been fortunate to have our own software developer at AMS, who has helped us navigate some of the advanced configuration which we would have probably struggled with. Whilst the initial training was necessary to gain and understanding of the fundamentals there is actually so much more to learn from the system, so I'm glad there seems to be more advanced training topics on specific areas. We could have built a process on the basic training but we have such a better process now from using the advanced tools, especially when we had a wide range of multiple sites as our customers. The Graphics for charts and KPI metrics whilst being functional, do look outdated in comparison to what is out there from some of the other suppliers. I believe there is a project to improve this which I can't wait to see. The Validation is a lot more manual, some suppliers offered what looked like a more automated package, although we will never know if this was the case. Again, there is some good work coming from the Validation team on improvements and looking forward to seeing a project they are working on to make validation more automated.
Réponse de l'équipe de AssurX
AssurX has since updated its graphics for charts and KPI metrics.
Ease of program
Commentaires : setting up new modules
the ease for queries. we can have this build to meet our needs.
Better merge with company ERP system. should have more training once up and running admins should have the know ow to make format changes.
Powerful Flexable Tool
Commentaires : My utility first developed a manual system built around AssurX to identify and trigger event driven tasks when the software, later with the help of AssurX services, an automated system was implemented based on the manual system that we developed. AssurX support and development is first rate and my experience has been overwhelmingly positive. My Representative [SENSITIVE CONTENT HIDDEN] has always provided quick response and has always provided a solution that resolves the issue or request.
The basic EUEM Electric Utility Package allows easy compliance evidence collection task scheduling and oversight. The software is powerful and flexible enough to allow configuration and customization to allow complex automated notifications and evidence collection based on circumstances.
Because it is so powerful and can be configured to do almost anything, the configuration process and learning curve can be intimidating. Although the EUEM utilities package is well developed for basic use. AssurX was unable to provide a roadmap for implementing it for my system. Basically I was handed the software and told to implement it. There was little guidance as to what questions I needed to ask myself about what I wanted the software to do or guidance as to best practices for implementation. I felt like I was reinventing the wheel.
Commentaires : We are using for corrective and preventative actions, manufacturing and supplier non-conforming part tracking, internal ISO9001 audits and RMA repair activity. Tracking CAPA progress, reporting activity to suppliers and customers and exporting data for reporting is all much easier with the software. Customer audits score higher due to controls established with software.
Great flexibility in configuration, covers complete range of quality and compliance needs. Cloud base saves on support issues. Ability to tailor implementation to specific needs. Link to ERP system is seamless. When proper time is spent planning implementation and configuring to specific needs the product is very easy to use and well received.
Key is with implementation, the software is very flexible and can lead to issues if not configured to match business needs. Configuration tools are easily accesses but documentation is light, requires resource training and time or use of consulting services. Consulting services are very good but have cost associated. Pricing structure is less attractive as user licenses increase.