Wer nutzt diese Software?
Especially well suited for regulated industries such as: Medical Device, Life Sciences, FDA Regulated, Manufacturing, Utilities, but ideal for any industry or company size.
Durchschnittliche Bewertung13 Bewertungen
- Gesamt 4.5 / 5
- Benutzerfreundlichkeit 4 / 5
- Kundenservice 5 / 5
- Funktionen 4.5 / 5
- Preis-Leistungs-Verhältnis 4.5 / 5
- Kostenlose Version Nein
- Kostenlose Testversion Nein
Cloud, SaaS, Web
Support währen der Geschäftszeiten
Angaben zum Hersteller
- Gegründet 1993
- Morgan Hill, CA
Simplify quality management + regulatory compliance with one versatile system. The AssurX platform is a software system that automates quality and compliance to help companies streamline workflow, control risk and better manage their operations. Begin with functionality you need now, then implement what you like as you're ready. No other system is easier to deploy, configure, use and modify. Companies of every size and industry - that's 100s of 1000s of users worldwide - rely on AssurX daily.
- Nachverfolgung von Nicht-Einhaltungen
- Compliance Management
- Korrekturmaßnahmen (CAPA)
- Nachverfolgung von Nicht-Einhaltungen
- Verfolgen von Fehlern
Die hilfreichsten Reviews für AssurX
Bewertet am 18.10.2018
An agile solution that doesn't compromise on compliance.
Kommentare: 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.
Vorteile: 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.
Nachteile: 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.
Bewertet am 30.1.2018
Working with the group at AssurX has been great. Very supportive and collaborative.
All of our processes are in one place.
We currently have 7 processes in CATSWeb.
The system is extremely customizable to fit your system requirements.
Working with AssurX is great. They are very responsive to your questions and will work with you to solve a problem you are having.
CATSWeb offers several starting points for a wide number of process that you can then customize to fit your needs.
Nachteile: Every system out there is going to have its quirks. One system may have a few more features than another and that is true with CATSWeb. We have found that because CATSWeb is so customizable, that puts more of a burden on the customer to have an extremely strong requirements document up front. Don't assume that the system will do something for you. Make sure it is listed as a requirement.